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NCT Number: NCT04375280

Evaluation of Impaired Mobility in Chronic Illness Constitution of a Cohort

Chronic illness is a public health issue and mobility loss is frequent in this population. Among its' multiple physical and psychological consequences, increased mortality and cardiovascular morbidity seem the main concern. Therefore, the exploration of locomotor deficiencies, physical capacities and metabolism of patients with chronic illnesses constitutes a major challenge both for the treatment of causal pathologies, as well as for evaluating the impact of therapeutic interventions, the benefit of which will be an improvement in physical capacities and ultimately mobility. In view of the hypothesis of an increase in the prevalence of mobility disorders in this population, this approach is part of a logic of screening and improving the effectiveness of the care of these patients with a multidisciplinary evaluation of individual risks. The EVALMOB protocol was designed in order to try to determine a standard profile of "dysmobility" in patients with chronic illness

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Key information

Conditions

Joint Osteoarthritis Atherosclerosis of the Distal Arteries, Without Gangrene Basal Ganglia Diseases Body Weight Brain Diseases Central Nervous System Diseases Chronic Disease Chronic Obstructive Pulmonary Disease, Unspecified Disease Attributes Lung Diseases Lung Diseases, Obstructive Movement Disorders Nervous System Diseases Neurodegenerative Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Unspecified Overnutrition Overweight Parkinson Disease Parkinsonian Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases Signs and Symptoms Synucleinopathies

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chu Clermont Ferrand

Clermont-Ferrand, 63003, France

Location status: Recruiting

Location contact

Frédéric Costes

PRINCIPAL_INVESTIGATOR

Lise Laclautre

CONTACT

[email protected]

About this study

We propose to constitute a prospective cohort of subjects carrying chronic disease. The objective is to explore all the different components of mobility (balance, muscle force, body composition, walking ability, metabolism, etc.), to assess their impact on the functional capacity of individuals and to identify their potential interactions. Processing this data could ultimately allow the development of a model to determine a composite standard profile of "dysmobility" in patients with chronic disease.

In the present protocol, parameters will be measured on five occasions (at inclusion, at 6 months from the inclusion day, at 1,2 and 5 year(s) from the inclusion day). All tests will be performed on the same day. New assessments will be done on the same principle as the initial evaluation.

Statistical analyses will be carried out using Stata software (version 13, StataCorp, College Station, USA). Data will be described by frequencies and percentages for categorical variables and by means and standard deviation (or median and interquartile range if data are not normally distributed) for continuous variables. The normality of continuous data will be assessed graphically and using the Shapiro-Wilk test. The main analysis will consist in determining patient profiles regarding their mobility. Clustering-type approaches (supervised or not) will be proposed: k-means, vector machine support, machine learning, factor analysis. For example, factor analyses on mixed data will allow the main components of mobility to be characterized. They can be followed by an ascending hierarchical classification in order to determine homogeneous groups of patients.

These groups will be described and compared on the main criteria evaluated using standard statistical tests: chi2 test (or Fisher's exact test if applicable) for the categorical criteria and using an analysis of variance (or Kruskal-Wallis if data are not normally distributed) for continuous criteria. The main analysis will be broken down more specifically for each of the pathologies considered. In addition, the sensitivity to change will be assessed in each pathology and for each assessment criterion. The search for factors related to the evolution of the different criteria will be carried out using usual tests and mixed multivariate models (logistics for categorical / linear criteria for continuous criteria) considering the subject as a random effect, and adjusting on the time criteria (inclusion / follow-up) and the criteria highlighted in the univariate analyses and in light of the elements reported in the literature. A sensitivity analysis will be proposed in order to study the statistical nature of the missing data and to propose, if necessary, the most suitable method of imputing the data: multiple imputation, maximum bias or LOCF in the case of longitudinal data.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Man or woman aged 18 to 90.
  • Patients with chronic pathology contributing to impaired mobility.
  • Volunteers who have given their written consent.
  • Affiliated to French health care system (for France)

Exclusion criteria

  • Patients suffering from progressive psychiatric pathologies (active psychosis, hallucinations, etc.) or the presence of another serious unstabilized pathology (decompensated heart failure, progressive terminal cancer, etc.).
  • People with poorly controlled or unstable cardiovascular disease.
  • Major osteoarticular or neurological problems completely preventing the proper performance of the various tests.
  • Non-autonomous patient
  • Persons under guardianship, curatorship, deprived of liberty or safeguarding justice.
  • People excluded from another study.
  • Pregnant or lactating women.

Treatment and study plan

Development of a screening algorithm designed to determine a "dysmobility" profile in patients with chronic illness.

Other

Firstly, volunteers will be invited to complete online questionnaires on a secure platform. The mobility assessment will be carried out initially (t1) and up to a maximum of 4 times (t1 to t4) as part of a day hospitalization. Questionnaires will be diverse (SF36, KOOS, HOOS, BROCKER, MNA, TAMPA, etc.) in order to assess several aspects that compose mobility.

Physical evaluations will include various validated tests (isokinetic strength measure, TUG, 6MWT, Berg Balance Scale, etc.)

Primary outcomes

  1. dismobility score calculated from the results reported in secondary outcomes

    Time frame: Day 0

    The main objective being to determine patient profiles with regard to "dysmobility", all the criteria detailed as secondary outcomes will be considered for the definition of the profiles

  2. dismobility score calculated from the results reported in secondary outcomes

    Time frame: Month 6

    The main objective being to determine patient profiles with regard to "dysmobility", all the criteria detailed as secondary outcomes will be considered for the definition of the profiles

  3. dismobility score calculated from the results reported in secondary outcomes

    Time frame: Year 1

    The main objective being to determine patient profiles with regard to "dysmobility", all the criteria detailed as secondary outcomes will be considered for the definition of the profiles

  4. dismobility score calculated from the results reported in secondary outcomes

    Time frame: Year 2

    The main objective being to determine patient profiles with regard to "dysmobility", all the criteria detailed as secondary outcomes will be considered for the definition of the profiles

  5. dismobility score calculated from the results reported in secondary outcomes

    Time frame: Year 5

    The main objective being to determine patient profiles with regard to "dysmobility", all the criteria detailed as secondary outcomes will be considered for the definition of the profiles

Secondary outcomes

  1. The main objective being to determine patient profiles with regard to "dysmobility", all the criteria detailed as secondary outcomes will be considered for the definition of the profiles

    Time frame: Day 0

    Demographics information will be obtained using a single questionnaire including questions on age, gender, qualification, personal work status, ethnicity, life and occupational events.

  2. Weight (Kg).

    Time frame: Day 0

    Weight will be measured with the medical body weight scale SECA® and according to the ISAK recommendations.

  3. Weight (Kg).

    Time frame: Month 6

    Weight will be measured with the medical body weight scale SECA® and according to the ISAK recommendations.

  4. Weight (Kg).

    Time frame: Year 1

    Weight will be measured with the medical body weight scale SECA® and according to the ISAK recommendations.

  5. Weight (Kg).

    Time frame: Year 2

    Weight will be measured with the medical body weight scale SECA® and according to the ISAK recommendations.

  6. Weight (Kg).

    Time frame: Year 5

    Weight will be measured with the medical body weight scale SECA® and according to the ISAK recommendations.

  7. Height (cm).

    Time frame: Day 0

    Height will be measured with a wall mounted tape measure and according to the ISAK recommendations

  8. Height (cm).

    Time frame: Month 6

    Height will be measured with a wall mounted tape measure and according to the ISAK recommendations

  9. Height (cm).

    Time frame: Year 1

    Height will be measured with a wall mounted tape measure and according to the ISAK recommendations

  10. Height (cm).

    Time frame: Year 2

    Height will be measured with a wall mounted tape measure and according to the ISAK recommendations

  11. Height (cm).

    Time frame: Year 5

    Height will be measured with a wall mounted tape measure and according to the ISAK recommendations

  12. Body fat percentage (%).

    Time frame: Day 0

    Body fat percentage will be measured with the Harpenden skinfold caliper by measuring skinfold thickness in four different sites (triceps; biceps, suprailiac, subscapular).

  13. Body fat percentage (%).

    Time frame: Month 6

    Body fat percentage will be measured with the Harpenden skinfold caliper by measuring skinfold thickness in four different sites (triceps; biceps, suprailiac, subscapular).

  14. Body fat percentage (%).

    Time frame: Year 1

    Body fat percentage will be measured with the Harpenden skinfold caliper by measuring skinfold thickness in four different sites (triceps; biceps, suprailiac, subscapular).

  15. Body fat percentage (%).

    Time frame: Year 2

    Body fat percentage will be measured with the Harpenden skinfold caliper by measuring skinfold thickness in four different sites (triceps; biceps, suprailiac, subscapular).

  16. Body fat percentage (%).

    Time frame: Year 5

    Body fat percentage will be measured with the Harpenden skinfold caliper by measuring skinfold thickness in four different sites (triceps; biceps, suprailiac, subscapular).

  17. Waist circumference (cm).

    Time frame: Day 0

    Waist circumference will be measured with a medical body tape measure and according to the ISAK recommendations

  18. Waist circumference (cm).

    Time frame: Month 5

    Waist circumference will be measured with a medical body tape measure and according to the ISAK recommendations

  19. Waist circumference (cm).

    Time frame: Year 1

    Waist circumference will be measured with a medical body tape measure and according to the ISAK recommendations

  20. Waist circumference (cm).

    Time frame: Year 2

    Waist circumference will be measured with a medical body tape measure and according to the ISAK recommendations

  21. Waist circumference (cm).

    Time frame: Year 5

    Waist circumference will be measured with a medical body tape measure and according to the ISAK recommendations

  22. Hip circumference (cm).

    Time frame: Day 0

    Hip circumference will be measured with a medical body tape measure and according to the ISAK recommendations.

  23. Hip circumference (cm).

    Time frame: Month 6

    Hip circumference will be measured with a medical body tape measure and according to the ISAK recommendations.

  24. Hip circumference (cm).

    Time frame: Year 1

    Hip circumference will be measured with a medical body tape measure and according to the ISAK recommendations.

  25. Hip circumference (cm).

    Time frame: Year 2

    Hip circumference will be measured with a medical body tape measure and according to the ISAK recommendations.

  26. Hip circumference (cm).

    Time frame: Year 5

    Hip circumference will be measured with a medical body tape measure and according to the ISAK recommendations.

  27. Brachial circumference (cm).

    Time frame: Day 0

    Brachial circumference will be measured with a medical body tape measure and according to the ISAK recommendations.

  28. Brachial circumference (cm).

    Time frame: Month 6

    Brachial circumference will be measured with a medical body tape measure and according to the ISAK recommendations.

  29. Brachial circumference (cm).

    Time frame: Year 1

    Brachial circumference will be measured with a medical body tape measure and according to the ISAK recommendations.

  30. Brachial circumference (cm).

    Time frame: Year 2

    Brachial circumference will be measured with a medical body tape measure and according to the ISAK recommendations.

  31. Brachial circumference (cm).

    Time frame: Year 5

    Brachial circumference will be measured with a medical body tape measure and according to the ISAK recommendations.

  32. Calf circumference (cm).

    Time frame: Day 0

    Calf circumference will be measured with a medical body tape measure and according to the ISAK recommendations

  33. Calf circumference (cm).

    Time frame: Month 6

    Calf circumference will be measured with a medical body tape measure and according to the ISAK recommendations

  34. Calf circumference (cm).

    Time frame: Year 1

    Calf circumference will be measured with a medical body tape measure and according to the ISAK recommendations

  35. Calf circumference (cm).

    Time frame: Year 2

    Calf circumference will be measured with a medical body tape measure and according to the ISAK recommendations

  36. Calf circumference (cm).

    Time frame: Year 5

    Calf circumference will be measured with a medical body tape measure and according to the ISAK recommendations

  37. Body Mass Index (Kg/m²).

    Time frame: Day 0

    BMI will be calculated (weight in kilograms divided by height in meters squared).

  38. Body Mass Index (Kg/m²).

    Time frame: Month 6

    BMI will be calculated (weight in kilograms divided by height in meters squared).

  39. Body Mass Index (Kg/m²).

    Time frame: Year 1

    BMI will be calculated (weight in kilograms divided by height in meters squared).

  40. Body Mass Index (Kg/m²).

    Time frame: Year 2

    BMI will be calculated (weight in kilograms divided by height in meters squared).

  41. Body Mass Index (Kg/m²).

    Time frame: Year 5

    BMI will be calculated (weight in kilograms divided by height in meters squared).

  42. Body composition

    Time frame: Day 0

    Body composition (muscle and fat) will be measured using he Bodystat® Impedance-meter.

  43. Body composition

    Time frame: Month 6

    Body composition (muscle and fat) will be measured using he Bodystat® Impedance-meter.

  44. Body composition

    Time frame: Year 1

    Body composition (muscle and fat) will be measured using he Bodystat® Impedance-meter.

  45. Body composition

    Time frame: Year 2

    Body composition (muscle and fat) will be measured using he Bodystat® Impedance-meter.

  46. Body composition

    Time frame: Year 5

    Body composition (muscle and fat) will be measured using he Bodystat® Impedance-meter.

  47. T-score (DS).

    Time frame: DAy 0

    • Description: T-score will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.

  48. T-score (DS).

    Time frame: Month 6

    • Description: T-score will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.

  49. T-score (DS).

    Time frame: Year 1

    • Description: T-score will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.

  50. T-score (DS).

    Time frame: Year 2

    • Description: T-score will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.

  51. T-score (DS).

    Time frame: Year 5

    • Description: T-score will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.

  52. Z-score (DS).

    Time frame: Day 0

    Z-score will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer

  53. Z-score (DS).

    Time frame: Month 6

    Z-score will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer

  54. Z-score (DS).

    Time frame: Year 1

    Z-score will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer

  55. Z-score (DS).

    Time frame: Year 2

    Z-score will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer

  56. Z-score (DS).

    Time frame: Year 5

    Z-score will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer

  57. Fat mass

    Time frame: Day 0

    Fat mass will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.

  58. Fat mass

    Time frame: Month 6

    Fat mass will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.

  59. Fat mass

    Time frame: Year 1

    Fat mass will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.

  60. Fat mass

    Time frame: Year 2

    Fat mass will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.

  61. Fat mass

    Time frame: Year 5

    Fat mass will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.

  62. Fat-free mass (%).

    Time frame: Day 0

    : Fat free mass will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.

  63. Fat-free mass (%).

    Time frame: Month 6

    : Fat free mass will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.

  64. Fat-free mass (%).

    Time frame: Year 1

    : Fat free mass will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.

  65. Fat-free mass (%).

    Time frame: Year 2

    : Fat free mass will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.

  66. Fat-free mass (%).

    Time frame: Year 5

    : Fat free mass will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.

  67. Fat mas index (Kg/m²).

    Time frame: Day 0

    Fat mas index will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.

  68. Fat mas index (Kg/m²).

    Time frame: Month 6

    Fat mas index will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.

  69. Fat mas index (Kg/m²).

    Time frame: Year 1

    Fat mas index will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.

  70. Fat mas index (Kg/m²).

    Time frame: Year 2

    Fat mas index will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.

  71. Fat mas index (Kg/m²).

    Time frame: Year 5

    Fat mas index will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.

  72. Ratio of android to gynoid fat mass.

    Time frame: Day 0

    Ratio of android to gynoid fat mass will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer

  73. Ratio of android to gynoid fat mass.

    Time frame: Month 6

    Ratio of android to gynoid fat mass will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer

  74. Ratio of android to gynoid fat mass.

    Time frame: Year 1

    Ratio of android to gynoid fat mass will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer

  75. Ratio of android to gynoid fat mass.

    Time frame: Year 2

    Ratio of android to gynoid fat mass will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer

  76. Ratio of android to gynoid fat mass.

    Time frame: Year 5

    Ratio of android to gynoid fat mass will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer

  77. Visceral adipose tissue (Kg).

    Time frame: Day 0

    Visceral fat mass will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.

  78. Visceral adipose tissue (Kg).

    Time frame: Month 6

    Visceral fat mass will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.

  79. Visceral adipose tissue (Kg).

    Time frame: Year 1

    Visceral fat mass will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.

  80. Visceral adipose tissue (Kg).

    Time frame: Year 2

    Visceral fat mass will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.

  81. Visceral adipose tissue (Kg).

    Time frame: Year 5

    Visceral fat mass will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.

  82. Fat-free mass index (kg/m²).

    Time frame: Day 0

    : Fat-free mass index will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.

  83. Fat-free mass index (kg/m²).

    Time frame: Month 6

    : Fat-free mass index will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.

  84. Fat-free mass index (kg/m²).

    Time frame: Year 1

    : Fat-free mass index will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.

  85. Fat-free mass index (kg/m²).

    Time frame: Year 2

    : Fat-free mass index will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.

  86. Fat-free mass index (kg/m²).

    Time frame: Year 5

    : Fat-free mass index will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.

  87. Appendicular fat-free mass index (Kg/m²).

    Time frame: Day 0

    Appendicular fat-free mass will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.

  88. Appendicular fat-free mass index (Kg/m²).

    Time frame: Month 6

    Appendicular fat-free mass will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.

  89. Appendicular fat-free mass index (Kg/m²).

    Time frame: Year 1

    Appendicular fat-free mass will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.

  90. Appendicular fat-free mass index (Kg/m²).

    Time frame: Year 2

    Appendicular fat-free mass will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.

  91. Appendicular fat-free mass index (Kg/m²).

    Time frame: Year 5

    Appendicular fat-free mass will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.

  92. Bone mass (Kg)

    Time frame: Day 0

    • Description: Bone mass will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.

  93. Bone mass (Kg)

    Time frame: Month 6

    • Description: Bone mass will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.

  94. Bone mass (Kg)

    Time frame: Year 1

    • Description: Bone mass will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.

  95. Bone mass (Kg)

    Time frame: Year 2

    • Description: Bone mass will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.

  96. Bone mass (Kg)

    Time frame: Year 5

    • Description: Bone mass will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.

  97. Daily caloric intake (Kcal/24h).

    Time frame: Day 0

    Daily caloric intake will be estimated with a 24-hour (all foods and beverages consumed by the respondent in the past 24 hours).

  98. Daily caloric intake (Kcal/24h).

    Time frame: Month 6

    Daily caloric intake will be estimated with a 24-hour (all foods and beverages consumed by the respondent in the past 24 hours).

  99. Daily caloric intake (Kcal/24h).

    Time frame: Year 1

    Daily caloric intake will be estimated with a 24-hour (all foods and beverages consumed by the respondent in the past 24 hours).

  100. Daily caloric intake (Kcal/24h).

    Time frame: Year 2

    Daily caloric intake will be estimated with a 24-hour (all foods and beverages consumed by the respondent in the past 24 hours).

  101. Daily caloric intake (Kcal/24h).

    Time frame: Year 5

    Daily caloric intake will be estimated with a 24-hour (all foods and beverages consumed by the respondent in the past 24 hours).

  102. Daily protein intake (in g and as a percentage of total caloric intake).

    Time frame: Day 0

    Daily protein intake will be estimated with a 24-hour (all foods and beverages consumed by the respondent in the past 24 hours).

  103. Daily protein intake (in g and as a percentage of total caloric intake).

    Time frame: Month 6

    Daily protein intake (in g and as a percentage of total caloric intake).

  104. Daily protein intake (in g and as a percentage of total caloric intake).

    Time frame: Year 1

    Daily protein intake will be estimated with a 24-hour (all foods and beverages consumed by the respondent in the past 24 hours).

  105. Daily protein intake (in g and as a percentage of total caloric intake).

    Time frame: Year 2

    Daily protein intake will be estimated with a 24-hour (all foods and beverages consumed by the respondent in the past 24 hours).

  106. Daily protein intake (in g and as a percentage of total caloric intake).

    Time frame: Year 5

    Daily protein intake will be estimated with a 24-hour (all foods and beverages consumed by the respondent in the past 24 hours).

  107. Daily carbohydrate intake (in g and as a percentage of total caloric intake).

    Time frame: Day 0

    Daily carbohydrate intake will be estimated with a 24-hour (all foods and beverages consumed by the respondent in the past 24 hours).

  108. Daily carbohydrate intake (in g and as a percentage of total caloric intake).

    Time frame: Month 6

    Daily carbohydrate intake will be estimated with a 24-hour (all foods and beverages consumed by the respondent in the past 24 hours).

  109. Daily carbohydrate intake (in g and as a percentage of total caloric intake).

    Time frame: Year 1

    Daily carbohydrate intake will be estimated with a 24-hour (all foods and beverages consumed by the respondent in the past 24 hours).

  110. Daily carbohydrate intake (in g and as a percentage of total caloric intake).

    Time frame: Year 2

    Daily carbohydrate intake will be estimated with a 24-hour (all foods and beverages consumed by the respondent in the past 24 hours).

  111. Daily carbohydrate intake (in g and as a percentage of total caloric intake).

    Time frame: Year 5

    Daily carbohydrate intake will be estimated with a 24-hour (all foods and beverages consumed by the respondent in the past 24 hours).

  112. Daily fat intake (in g and as a percentage of total caloric intake).

    Time frame: Day 0

    Daily fat intake will be estimated with a 24-hour (all foods and beverages consumed by the respondent in the past 24 hours).

  113. Daily fat intake (in g and as a percentage of total caloric intake).

    Time frame: Month 6

    Daily fat intake will be estimated with a 24-hour (all foods and beverages consumed by the respondent in the past 24 hours).

  114. Daily fat intake (in g and as a percentage of total caloric intake).

    Time frame: Year 1

    Daily fat intake will be estimated with a 24-hour (all foods and beverages consumed by the respondent in the past 24 hours).

  115. Daily fat intake (in g and as a percentage of total caloric intake).

    Time frame: Year 2

    Daily fat intake will be estimated with a 24-hour (all foods and beverages consumed by the respondent in the past 24 hours).

  116. Daily fat intake (in g and as a percentage of total caloric intake).

    Time frame: Year 5

    Daily fat intake will be estimated with a 24-hour (all foods and beverages consumed by the respondent in the past 24 hours).

  117. Nutritional status assessment

    Time frame: Day 0

    Nutritional status assessment will be assessed with the Mini Nutritional Assessment Questionnaire.

  118. Nutritional status assessment

    Time frame: Month 6

    Nutritional status assessment will be assessed with the Mini Nutritional Assessment Questionnaire.

  119. Nutritional status assessment

    Time frame: Year 1

    Nutritional status assessment will be assessed with the Mini Nutritional Assessment Questionnaire.

  120. Nutritional status assessment

    Time frame: Year 2

    Nutritional status assessment will be assessed with the Mini Nutritional Assessment Questionnaire.

  121. Nutritional status assessment

    Time frame: Year 5

    Nutritional status assessment will be assessed with the Mini Nutritional Assessment Questionnaire.

  122. Risk of undernutrition.

    Time frame: Day 0

    Risk of undernutrition will be assessed with the Brocker Questionnaire

  123. Risk of undernutrition.

    Time frame: Month 6

    Risk of undernutrition will be assessed with the Brocker Questionnaire

  124. Risk of undernutrition.

    Time frame: Year 1

    Risk of undernutrition will be assessed with the Brocker Questionnaire

  125. Risk of undernutrition.

    Time frame: Year 2

    Risk of undernutrition will be assessed with the Brocker Questionnaire

  126. Risk of undernutrition.

    Time frame: Year 5

    Risk of undernutrition will be assessed with the Brocker Questionnaire

  127. Basic biology.

    Time frame: Day 0

    : Basic biology will be measured using endocrine assays (fasting blood glucose, HbA1c, HDL-c and LDL-c, TG, CPK)

  128. Basic biology.

    Time frame: Month 6

    : Basic biology will be measured using endocrine assays (fasting blood glucose, HbA1c, HDL-c and LDL-c, TG, CPK)

  129. Basic biology.

    Time frame: Year 1

    : Basic biology will be measured using endocrine assays (fasting blood glucose, HbA1c, HDL-c and LDL-c, TG, CPK)

  130. Basic biology.

    Time frame: Year 2

    : Basic biology will be measured using endocrine assays (fasting blood glucose, HbA1c, HDL-c and LDL-c, TG, CPK)

  131. Basic biology.

    Time frame: Year 5

    : Basic biology will be measured using endocrine assays (fasting blood glucose, HbA1c, HDL-c and LDL-c, TG, CPK)

  132. Maximum voluntary isometric strength of the quadriceps muscles at 45° (Nm).

    Time frame: Day 0

    : Maximum voluntary isometric strength of the quadriceps muscles will be measured with the HUMA® /NORM™ device.

  133. Maximum voluntary isometric strength of the quadriceps muscles at 45° (Nm).

    Time frame: Month 6

    : Maximum voluntary isometric strength of the quadriceps muscles will be measured with the HUMA® /NORM™ device.

  134. Maximum voluntary isometric strength of the quadriceps muscles at 45° (Nm).

    Time frame: Year 1

    : Maximum voluntary isometric strength of the quadriceps muscles will be measured with the HUMA® /NORM™ device.

  135. Maximum voluntary isometric strength of the quadriceps muscles at 45° (Nm).

    Time frame: Year 2

    : Maximum voluntary isometric strength of the quadriceps muscles will be measured with the HUMA® /NORM™ device.

  136. Maximum voluntary isometric strength of the quadriceps muscles at 45° (Nm).

    Time frame: Year 5

    : Maximum voluntary isometric strength of the quadriceps muscles will be measured with the HUMA® /NORM™ device.

  137. Maximum voluntary isokinetic strength of the quadriceps muscles at 60°/s (Nm).

    Time frame: Day 0

    • Description: Maximum voluntary isokinetic strength of the quadriceps muscles at 60°/s will be measured with the HUMA® /NORM™ device.

  138. Maximum voluntary isokinetic strength of the quadriceps muscles at 60°/s (Nm).

    Time frame: Month 6

    • Description: Maximum voluntary isokinetic strength of the quadriceps muscles at 60°/s will be measured with the HUMA® /NORM™ device.

  139. Maximum voluntary isokinetic strength of the quadriceps muscles at 60°/s (Nm).

    Time frame: Year 1

    • Description: Maximum voluntary isokinetic strength of the quadriceps muscles at 60°/s will be measured with the HUMA® /NORM™ device.

  140. Maximum voluntary isokinetic strength of the quadriceps muscles at 60°/s (Nm).

    Time frame: Year 2

    • Description: Maximum voluntary isokinetic strength of the quadriceps muscles at 60°/s will be measured with the HUMA® /NORM™ device.

  141. Maximum voluntary isokinetic strength of the quadriceps muscles at 60°/s (Nm).

    Time frame: Year 5

    • Description: Maximum voluntary isokinetic strength of the quadriceps muscles at 60°/s will be measured with the HUMA® /NORM™ device.

  142. Maximum voluntary isokinetic strength of the quadriceps muscles at 240°/s (Nm).

    Time frame: Day 0

    Maximum voluntary isokinetic strength of the quadriceps muscles at 240°/s will be measured with the HUMA® /NORM™ device.

  143. Maximum voluntary isokinetic strength of the quadriceps muscles at 240°/s (Nm).

    Time frame: Month 6

    Maximum voluntary isokinetic strength of the quadriceps muscles at 240°/s will be measured with the HUMA® /NORM™ device.

  144. Maximum voluntary isokinetic strength of the quadriceps muscles at 240°/s (Nm).

    Time frame: Year 1

    Maximum voluntary isokinetic strength of the quadriceps muscles at 240°/s will be measured with the HUMA® /NORM™ device.

  145. Maximum voluntary isokinetic strength of the quadriceps muscles at 240°/s (Nm).

    Time frame: Year 2

    Maximum voluntary isokinetic strength of the quadriceps muscles at 240°/s will be measured with the HUMA® /NORM™ device.

  146. Maximum voluntary isokinetic strength of the quadriceps muscles at 240°/s (Nm).

    Time frame: Year 5

    Maximum voluntary isokinetic strength of the quadriceps muscles at 240°/s will be measured with the HUMA® /NORM™ device.

  147. Maximum voluntary isokinetic strength of the quadriceps muscles at 30°/s (eccentric contraction) (Nm).

    Time frame: Day 0

    Maximum voluntary isokinetic strength of the quadriceps muscles at 30°/s will be measured with the HUMA® /NORM™ device.

  148. Maximum voluntary isokinetic strength of the quadriceps muscles at 30°/s (eccentric contraction) (Nm).

    Time frame: Month 6

    Maximum voluntary isokinetic strength of the quadriceps muscles at 30°/s will be measured with the HUMA® /NORM™ device.

  149. Maximum voluntary isokinetic strength of the quadriceps muscles at 30°/s (eccentric contraction) (Nm).

    Time frame: Year 1

    Maximum voluntary isokinetic strength of the quadriceps muscles at 30°/s will be measured with the HUMA® /NORM™ device.

  150. Maximum voluntary isokinetic strength of the quadriceps muscles at 30°/s (eccentric contraction) (Nm).

    Time frame: Year 2

    Maximum voluntary isokinetic strength of the quadriceps muscles at 30°/s will be measured with the HUMA® /NORM™ device.

  151. Maximum voluntary isokinetic strength of the quadriceps muscles at 30°/s (eccentric contraction) (Nm).

    Time frame: Year 5

    Maximum voluntary isokinetic strength of the quadriceps muscles at 30°/s will be measured with the HUMA® /NORM™ device.

  152. Maximum voluntary isokinetic strength of the hamstring muscles at 60°/s (Nm).

    Time frame: Day 0

    Maximum voluntary isokinetic strength of the hamstring muscles at 60°/s will be measured with the HUMA® /NORM™ device.

  153. Maximum voluntary isokinetic strength of the hamstring muscles at 60°/s (Nm).

    Time frame: Month 6

    Maximum voluntary isokinetic strength of the hamstring muscles at 60°/s will be measured with the HUMA® /NORM™ device.

  154. Maximum voluntary isokinetic strength of the hamstring muscles at 60°/s (Nm).

    Time frame: Year 1

    Maximum voluntary isokinetic strength of the hamstring muscles at 60°/s will be measured with the HUMA® /NORM™ device.

  155. Maximum voluntary isokinetic strength of the hamstring muscles at 60°/s (Nm).

    Time frame: Year 2

    Maximum voluntary isokinetic strength of the hamstring muscles at 60°/s will be measured with the HUMA® /NORM™ device.

  156. Maximum voluntary isokinetic strength of the hamstring muscles at 60°/s (Nm).

    Time frame: Year 5

    Maximum voluntary isokinetic strength of the hamstring muscles at 60°/s will be measured with the HUMA® /NORM™ device.

  157. Maximum voluntary isokinetic strength of the hamstring muscles at 240°/s (Nm).

    Time frame: Day 0

    • Description: Maximum voluntary isokinetic strength of the hamstring muscles at 240°/s will be measured with the HUMA® /NORM™ device.

  158. Maximum voluntary isokinetic strength of the hamstring muscles at 240°/s (Nm).

    Time frame: Month 6

    • Description: Maximum voluntary isokinetic strength of the hamstring muscles at 240°/s will be measured with the HUMA® /NORM™ device.

  159. Maximum voluntary isokinetic strength of the hamstring muscles at 240°/s (Nm).

    Time frame: Year 1

    • Description: Maximum voluntary isokinetic strength of the hamstring muscles at 240°/s will be measured with the HUMA® /NORM™ device.

  160. Maximum voluntary isokinetic strength of the hamstring muscles at 240°/s (Nm).

    Time frame: Year 2

    • Description: Maximum voluntary isokinetic strength of the hamstring muscles at 240°/s will be measured with the HUMA® /NORM™ device.

  161. Maximum voluntary isokinetic strength of the hamstring muscles at 240°/s (Nm).

    Time frame: Year 5

    • Description: Maximum voluntary isokinetic strength of the hamstring muscles at 240°/s will be measured with the HUMA® /NORM™ device.

  162. Maximum voluntary isokinetic strength of the hamstring muscles at 30°/s (eccentric contraction) (Nm).

    Time frame: Day 0

    Maximum voluntary isokinetic strength of the hamstring muscles at 30°/s will be measured with the HUMA® /NORM™ device.

  163. Maximum voluntary isokinetic strength of the hamstring muscles at 30°/s (eccentric contraction) (Nm).

    Time frame: Month 6

    Maximum voluntary isokinetic strength of the hamstring muscles at 30°/s will be measured with the HUMA® /NORM™ device.

  164. Maximum voluntary isokinetic strength of the hamstring muscles at 30°/s (eccentric contraction) (Nm).

    Time frame: Year 1

    Maximum voluntary isokinetic strength of the hamstring muscles at 30°/s will be measured with the HUMA® /NORM™ device.

  165. Maximum voluntary isokinetic strength of the hamstring muscles at 30°/s (eccentric contraction) (Nm).

    Time frame: Year 2

    Maximum voluntary isokinetic strength of the hamstring muscles at 30°/s will be measured with the HUMA® /NORM™ device.

  166. Maximum voluntary isokinetic strength of the hamstring muscles at 30°/s (eccentric contraction) (Nm).

    Time frame: Year 5

    Maximum voluntary isokinetic strength of the hamstring muscles at 30°/s will be measured with the HUMA® /NORM™ device.

  167. Endurance coefficient of the quadriceps muscles at 180°/s.

    Time frame: Day 0

    Endurance coefficient will be estimated as a Σ Peak torque ratio of the last 3 contractions on the first 3 at 180°/s with the HUMA® /NORM™ device.

  168. Endurance coefficient of the quadriceps muscles at 180°/s.

    Time frame: Month 6

    Endurance coefficient will be estimated as a Σ Peak torque ratio of the last 3 contractions on the first 3 at 180°/s with the HUMA® /NORM™ device.

  169. Endurance coefficient of the quadriceps muscles at 180°/s.

    Time frame: Year 1

    Endurance coefficient will be estimated as a Σ Peak torque ratio of the last 3 contractions on the first 3 at 180°/s with the HUMA® /NORM™ device.

  170. Endurance coefficient of the quadriceps muscles at 180°/s.

    Time frame: Year 2

    Endurance coefficient will be estimated as a Σ Peak torque ratio of the last 3 contractions on the first 3 at 180°/s with the HUMA® /NORM™ device.

  171. Endurance coefficient of the quadriceps muscles at 180°/s.

    Time frame: Year 5

    Endurance coefficient will be estimated as a Σ Peak torque ratio of the last 3 contractions on the first 3 at 180°/s with the HUMA® /NORM™ device.

  172. Endurance coefficient of the hamstring muscles at 180°/s.

    Time frame: Day 0

    Endurance coefficient will be estimated as a Σ Peak torque ratio of the last 3 contractions on the first 3 at 180°/s with the HUMA® /NORM™ device..

  173. Endurance coefficient of the hamstring muscles at 180°/s.

    Time frame: Month 6

    Endurance coefficient will be estimated as a Σ Peak torque ratio of the last 3 contractions on the first 3 at 180°/s with the HUMA® /NORM™ device..

  174. Endurance coefficient of the hamstring muscles at 180°/s.

    Time frame: Year 1

    Endurance coefficient will be estimated as a Σ Peak torque ratio of the last 3 contractions on the first 3 at 180°/s with the HUMA® /NORM™ device..

  175. Endurance coefficient of the hamstring muscles at 180°/s.

    Time frame: Year 2

    Endurance coefficient will be estimated as a Σ Peak torque ratio of the last 3 contractions on the first 3 at 180°/s with the HUMA® /NORM™ device..

  176. Endurance coefficient of the hamstring muscles at 180°/s.

    Time frame: Year 5

    Endurance coefficient will be estimated as a Σ Peak torque ratio of the last 3 contractions on the first 3 at 180°/s with the HUMA® /NORM™ device..

  177. Functional ratio

    Time frame: Day 0

    Functional ratio will be estimated by dividing the maximum voluntary isokinetic strength of the hamstring muscles at 60°/s with the maximum voluntary isokinetic strength of the quadriceps muscles at 60°/s.

  178. Functional ratio

    Time frame: Month 6

    Functional ratio will be estimated by dividing the maximum voluntary isokinetic strength of the hamstring muscles at 60°/s with the maximum voluntary isokinetic strength of the quadriceps muscles at 60°/s.

  179. Functional ratio

    Time frame: Year 1

    Functional ratio will be estimated by dividing the maximum voluntary isokinetic strength of the hamstring muscles at 60°/s with the maximum voluntary isokinetic strength of the quadriceps muscles at 60°/s.

  180. Functional ratio

    Time frame: Year 2

    Functional ratio will be estimated by dividing the maximum voluntary isokinetic strength of the hamstring muscles at 60°/s with the maximum voluntary isokinetic strength of the quadriceps muscles at 60°/s.

  181. Functional ratio

    Time frame: Year 5

    Functional ratio will be estimated by dividing the maximum voluntary isokinetic strength of the hamstring muscles at 60°/s with the maximum voluntary isokinetic strength of the quadriceps muscles at 60°/s.

  182. Mixed ratio

    Time frame: Day 0

    • Mixed ratio will be estimated by dividing the maximum voluntary isokinetic strength of the hamstring muscles at 30°/s (eccentric contraction) with the maximum voluntary isokinetic strength of the quadriceps muscles at 240°/s Title: Maximum voluntary strength of the quadriceps muscles at 60°/s.

  183. Mixed ratio

    Time frame: Month 6

    • Mixed ratio will be estimated by dividing the maximum voluntary isokinetic strength of the hamstring muscles at 30°/s (eccentric contraction) with the maximum voluntary isokinetic strength of the quadriceps muscles at 240°/s Title: Maximum voluntary strength of the quadriceps muscles at 60°/s.

  184. Mixed ratio

    Time frame: Year 1

    • Mixed ratio will be estimated by dividing the maximum voluntary isokinetic strength of the hamstring muscles at 30°/s (eccentric contraction) with the maximum voluntary isokinetic strength of the quadriceps muscles at 240°/s Title: Maximum voluntary strength of the quadriceps muscles at 60°/s.

  185. Mixed ratio

    Time frame: Year 2

    • Mixed ratio will be estimated by dividing the maximum voluntary isokinetic strength of the hamstring muscles at 30°/s (eccentric contraction) with the maximum voluntary isokinetic strength of the quadriceps muscles at 240°/s Title: Maximum voluntary strength of the quadriceps muscles at 60°/s.

  186. Mixed ratio

    Time frame: Year 5

    • Mixed ratio will be estimated by dividing the maximum voluntary isokinetic strength of the hamstring muscles at 30°/s (eccentric contraction) with the maximum voluntary isokinetic strength of the quadriceps muscles at 240°/s Title: Maximum voluntary strength of the quadriceps muscles at 60°/s.

  187. Maximum voluntary hand grip strength (Kg).

    Time frame: Day 0

    Maximum voluntary hand grip strength will be measured with the Jamar® hydraulic dynamometer and with the Baseline® pneumatic dynamometer.

  188. Maximum voluntary hand grip strength (Kg).

    Time frame: Month 6

    Maximum voluntary hand grip strength will be measured with the Jamar® hydraulic dynamometer and with the Baseline® pneumatic dynamometer.

  189. Maximum voluntary hand grip strength (Kg).

    Time frame: Year 1

    Maximum voluntary hand grip strength will be measured with the Jamar® hydraulic dynamometer and with the Baseline® pneumatic dynamometer.

  190. Maximum voluntary hand grip strength (Kg).

    Time frame: Year 2

    Maximum voluntary hand grip strength will be measured with the Jamar® hydraulic dynamometer and with the Baseline® pneumatic dynamometer.

  191. Maximum voluntary hand grip strength (Kg).

    Time frame: Year 5

    Maximum voluntary hand grip strength will be measured with the Jamar® hydraulic dynamometer and with the Baseline® pneumatic dynamometer.

  192. Maximum voluntary pinch strength (Kg).

    Time frame: Day 0

    Maximum voluntary pinch strength will be measured with the Baseline® pinch gauche test mechanical dynamometer.

  193. Maximum voluntary pinch strength (Kg).

    Time frame: Month 6

    Maximum voluntary pinch strength will be measured with the Baseline® pinch gauche test mechanical dynamometer.

  194. Maximum voluntary pinch strength (Kg).

    Time frame: Year 1

    Maximum voluntary pinch strength will be measured with the Baseline® pinch gauche test mechanical dynamometer.

  195. Maximum voluntary pinch strength (Kg).

    Time frame: Year 2

    Maximum voluntary pinch strength will be measured with the Baseline® pinch gauche test mechanical dynamometer.

  196. Maximum voluntary pinch strength (Kg).

    Time frame: Year 5

    Maximum voluntary pinch strength will be measured with the Baseline® pinch gauche test mechanical dynamometer.

  197. Hip passive joint range

    Time frame: Day 0

    Hip joint range will be measured with a medical goniometer.

  198. Hip passive joint range

    Time frame: Month 6

    Hip joint range will be measured with a medical goniometer.

  199. Hip passive joint range

    Time frame: Year 1

    Hip joint range will be measured with a medical goniometer.

  200. Hip passive joint range

    Time frame: Year 2

    Hip joint range will be measured with a medical goniometer.

  201. Hip passive joint range

    Time frame: Year 5

    Hip joint range will be measured with a medical goniometer.

  202. Knee passive joint range.

    Time frame: Day 0

    Knee joint range will be measured with a medical goniometer.

  203. Knee passive joint range.

    Time frame: Month 6

    Knee joint range will be measured with a medical goniometer.

  204. Knee passive joint range.

    Time frame: Year 1

    Knee joint range will be measured with a medical goniometer.

  205. Knee passive joint range.

    Time frame: Year 2

    Knee joint range will be measured with a medical goniometer.

  206. Knee passive joint range.

    Time frame: Year 5

    Knee joint range will be measured with a medical goniometer.

  207. Ankle passive joint range

    Time frame: Day 0

    Ankle joint range will be measured with a medical goniometer.

  208. Ankle passive joint range

    Time frame: Month 6

    Ankle joint range will be measured with a medical goniometer.

  209. Ankle passive joint range

    Time frame: Year 1

    Ankle joint range will be measured with a medical goniometer.

  210. Ankle passive joint range

    Time frame: Year 2

    Ankle joint range will be measured with a medical goniometer.

  211. Ankle passive joint range

    Time frame: Year 5

    Ankle joint range will be measured with a medical goniometer.

  212. Lower and upper limb muscle power assessment (MRC)

    Time frame: Day 0

    Lower and upper limb muscle power assessment will be performed by an experienced physician.

  213. Lower and upper limb muscle power assessment (MRC)

    Time frame: Month 6

    Lower and upper limb muscle power assessment will be performed by an experienced physician.

  214. Lower and upper limb muscle power assessment (MRC)

    Time frame: Year 1

    Lower and upper limb muscle power assessment will be performed by an experienced physician.

  215. Lower and upper limb muscle power assessment (MRC)

    Time frame: Year 2

    Lower and upper limb muscle power assessment will be performed by an experienced physician.

  216. Lower and upper limb muscle power assessment (MRC)

    Time frame: Year 5

    Lower and upper limb muscle power assessment will be performed by an experienced physician.

  217. Statokinesigram surface area (mm²)

    Time frame: Day 0

    Statokinesigram surface area will be measured with the STATIPRO® static posturography platform.

  218. Statokinesigram surface area (mm²)

    Time frame: Month 6

    Statokinesigram surface area will be measured with the STATIPRO® static posturography platform.

  219. Statokinesigram surface area (mm²)

    Time frame: Year 1

    Statokinesigram surface area will be measured with the STATIPRO® static posturography platform.

  220. Statokinesigram surface area (mm²)

    Time frame: Year 2

    Statokinesigram surface area will be measured with the STATIPRO® static posturography platform.

  221. Statokinesigram surface area (mm²)

    Time frame: Year 5

    Statokinesigram surface area will be measured with the STATIPRO® static posturography platform.

  222. Stabilogram length (mm).

    Time frame: Day 0

    Stabilogram length will be measured with the STATIPRO® static posturography platform

  223. Stabilogram length (mm).

    Time frame: Month 6

    Stabilogram length will be measured with the STATIPRO® static posturography platform

  224. Stabilogram length (mm).

    Time frame: Year 1

    Stabilogram length will be measured with the STATIPRO® static posturography platform

  225. Stabilogram length (mm).

    Time frame: Year 2

    Stabilogram length will be measured with the STATIPRO® static posturography platform

  226. Stabilogram length (mm).

    Time frame: Year 5

    Stabilogram length will be measured with the STATIPRO® static posturography platform

  227. Maximal deflection (forward, backward left and right).

    Time frame: Day 0

    Maximal deflection will be measured with the STATIPRO® static posturography platform.

  228. Maximal deflection (forward, backward left and right).

    Time frame: Month 6

    Maximal deflection will be measured with the STATIPRO® static posturography platform.

  229. Maximal deflection (forward, backward left and right).

    Time frame: Year 1

    Maximal deflection will be measured with the STATIPRO® static posturography platform.

  230. Maximal deflection (forward, backward left and right).

    Time frame: Year 2

    Maximal deflection will be measured with the STATIPRO® static posturography platform.

  231. Maximal deflection (forward, backward left and right).

    Time frame: Year 5

    Maximal deflection will be measured with the STATIPRO® static posturography platform.

  232. Velocity variations (mm/s).

    Time frame: Day 0

    : Velocity variations will be measured with the STATIPRO® static posturography platform.

  233. Velocity variations (mm/s).

    Time frame: Month 6

    : Velocity variations will be measured with the STATIPRO® static posturography platform.

  234. Velocity variations (mm/s).

    Time frame: Year 1

    : Velocity variations will be measured with the STATIPRO® static posturography platform.

  235. Velocity variations (mm/s).

    Time frame: Year 2

    : Velocity variations will be measured with the STATIPRO® static posturography platform.

  236. Velocity variations (mm/s).

    Time frame: Year 5

    : Velocity variations will be measured with the STATIPRO® static posturography platform.

  237. : Romberg ratio according to sway area

    Time frame: Day 0

    Romberg ratio will be measured with the STATIPRO® static posturography platform.

  238. : Romberg ratio according to sway area

    Time frame: Month 6

    Romberg ratio will be measured with the STATIPRO® static posturography platform.

  239. : Romberg ratio according to sway area

    Time frame: Year 1

    Romberg ratio will be measured with the STATIPRO® static posturography platform.

  240. : Romberg ratio according to sway area

    Time frame: Year 2

    Romberg ratio will be measured with the STATIPRO® static posturography platform.

  241. : Romberg ratio according to sway area

    Time frame: Year 5

    Romberg ratio will be measured with the STATIPRO® static posturography platform.

  242. Romberg ratio according to center of pressure path length

    Time frame: Day 0

    Romberg ratio will be measured with the STATIPRO® static posturography platform.

  243. Romberg ratio according to center of pressure path length

    Time frame: Month 6

    Romberg ratio will be measured with the STATIPRO® static posturography platform.

  244. Romberg ratio according to center of pressure path length

    Time frame: Year 1

    Romberg ratio will be measured with the STATIPRO® static posturography platform.

  245. Romberg ratio according to center of pressure path length

    Time frame: Year 2

    Romberg ratio will be measured with the STATIPRO® static posturography platform.

  246. Romberg ratio according to center of pressure path length

    Time frame: Year 5

    Romberg ratio will be measured with the STATIPRO® static posturography platform.

  247. : Plantar pressure ratio sway area.

    Time frame: Day 0

    Plantar pressure ratio sway area will be measured with the STATIPRO® static posturography platform.

  248. : Plantar pressure ratio sway area.

    Time frame: Month 6

    Plantar pressure ratio sway area will be measured with the STATIPRO® static posturography platform.

  249. : Plantar pressure ratio sway area.

    Time frame: Year 1

    Plantar pressure ratio sway area will be measured with the STATIPRO® static posturography platform.

  250. : Plantar pressure ratio sway area.

    Time frame: Year 2

    Plantar pressure ratio sway area will be measured with the STATIPRO® static posturography platform.

  251. : Plantar pressure ratio sway area.

    Time frame: Year 5

    Plantar pressure ratio sway area will be measured with the STATIPRO® static posturography platform.

  252. Plantar pressure ratio length.

    Time frame: Day 0

    Plantar pressure ratio length will be measured with the STATIPRO® static posturography platform.

  253. Plantar pressure ratio length.

    Time frame: Month 6

    Plantar pressure ratio length will be measured with the STATIPRO® static posturography platform.

  254. Plantar pressure ratio length.

    Time frame: Year 1

    Plantar pressure ratio length will be measured with the STATIPRO® static posturography platform.

  255. Plantar pressure ratio length.

    Time frame: Year 2

    Plantar pressure ratio length will be measured with the STATIPRO® static posturography platform.

  256. Plantar pressure ratio length.

    Time frame: Year 5

    Plantar pressure ratio length will be measured with the STATIPRO® static posturography platform.

  257. Walking velocity (cm/s).

    Time frame: Day 0

    Walking velocity will be measured with the GAITRite® Electronic Walkway.

  258. Walking velocity (cm/s).

    Time frame: Month 6

    Walking velocity will be measured with the GAITRite® Electronic Walkway.

  259. Walking velocity (cm/s).

    Time frame: Year 1

    Walking velocity will be measured with the GAITRite® Electronic Walkway.

  260. Walking velocity (cm/s).

    Time frame: Year 2

    Walking velocity will be measured with the GAITRite® Electronic Walkway.

  261. Walking velocity (cm/s).

    Time frame: Year 5

    Walking velocity will be measured with the GAITRite® Electronic Walkway.

  262. Cadence (steps/min).

    Time frame: Day 0

    : Cadence will be measured with the GAITRite® Electronic Walkway.

  263. Cadence (steps/min).

    Time frame: Month 6

    : Cadence will be measured with the GAITRite® Electronic Walkway.

  264. Cadence (steps/min).

    Time frame: Year 1

    : Cadence will be measured with the GAITRite® Electronic Walkway.

  265. Cadence (steps/min).

    Time frame: Year 2

    : Cadence will be measured with the GAITRite® Electronic Walkway.

  266. Cadence (steps/min).

    Time frame: Year 5

    : Cadence will be measured with the GAITRite® Electronic Walkway.

  267. Step length (left and right foot) (cm)

    Time frame: DAy 0

    Step length will be measured with the GAITRite® Electronic Walkway.

  268. Step length (left and right foot) (cm)

    Time frame: Month 6

    Step length will be measured with the GAITRite® Electronic Walkway.

  269. Step length (left and right foot) (cm)

    Time frame: Year 1

    Step length will be measured with the GAITRite® Electronic Walkway.

  270. Step length (left and right foot) (cm)

    Time frame: Year 2

    Step length will be measured with the GAITRite® Electronic Walkway.

  271. Step length (left and right foot) (cm)

    Time frame: Year 5

    Step length will be measured with the GAITRite® Electronic Walkway.

  272. Stride length (cm).

    Time frame: Day 0

    Stride length will be measured with the GAITRite® Electronic Walkway.

  273. Stride length (cm).

    Time frame: month 6

    Stride length will be measured with the GAITRite® Electronic Walkway.

  274. Stride length (cm).

    Time frame: year 1

    Stride length will be measured with the GAITRite® Electronic Walkway.

  275. Stride length (cm).

    Time frame: year 2

    Stride length will be measured with the GAITRite® Electronic Walkway.

  276. Stride length (cm).

    Time frame: year 5

    Stride length will be measured with the GAITRite® Electronic Walkway.

  277. Single support time left and right foot (s).

    Time frame: Day 0

    Single support time will be measured with the GAITRite® Electronic Walkway.

  278. Single support time left and right foot (s).

    Time frame: Month 6

    Single support time will be measured with the GAITRite® Electronic Walkway.

  279. Single support time left and right foot (s).

    Time frame: Year 1

    Single support time will be measured with the GAITRite® Electronic Walkway.

  280. Single support time left and right foot (s).

    Time frame: Year 2

    Single support time will be measured with the GAITRite® Electronic Walkway.

  281. Single support time left and right foot (s).

    Time frame: Year 5

    Single support time will be measured with the GAITRite® Electronic Walkway.

  282. Double support time (s).

    Time frame: Day 0

    : Double support time will be measured with the GAITRite® Electronic Walkway.

  283. Double support time (s).

    Time frame: Month 6

    : Double support time will be measured with the GAITRite® Electronic Walkway.

  284. Double support time (s).

    Time frame: YEar 1

    : Double support time will be measured with the GAITRite® Electronic Walkway.

  285. Double support time (s).

    Time frame: Year 2

    : Double support time will be measured with the GAITRite® Electronic Walkway.

  286. Double support time (s).

    Time frame: Year 5

    : Double support time will be measured with the GAITRite® Electronic Walkway.

  287. Swing time (s).

    Time frame: Day 0

    : Swing time will be measured with the GAITRite® Electronic Walkway.

  288. Swing time (s).

    Time frame: Month 6

    : Swing time will be measured with the GAITRite® Electronic Walkway.

  289. Swing time (s).

    Time frame: Year 1

    : Swing time will be measured with the GAITRite® Electronic Walkway.

  290. Swing time (s).

    Time frame: Year 2

    : Swing time will be measured with the GAITRite® Electronic Walkway.

  291. Swing time (s).

    Time frame: Year 5

    : Swing time will be measured with the GAITRite® Electronic Walkway.

  292. Swing phase (as a % of walking cycle).

    Time frame: DAy 0

    : Swing phase will be measured with the GAITRite® Electronic Walkway.

  293. Swing phase (as a % of walking cycle).

    Time frame: Month 6

    : Swing phase will be measured with the GAITRite® Electronic Walkway.

  294. Swing phase (as a % of walking cycle).

    Time frame: Year 1

    : Swing phase will be measured with the GAITRite® Electronic Walkway.

  295. Swing phase (as a % of walking cycle).

    Time frame: Year 2

    : Swing phase will be measured with the GAITRite® Electronic Walkway.

  296. Swing phase (as a % of walking cycle).

    Time frame: Year 5

    : Swing phase will be measured with the GAITRite® Electronic Walkway.

  297. Stance phase (as a % of walking cycle).

    Time frame: Day 0

    Stance phase will be measured with the GAITRite® Electronic Walkway.

  298. Stance phase (as a % of walking cycle).

    Time frame: Month 6

    Stance phase will be measured with the GAITRite® Electronic Walkway.

  299. Stance phase (as a % of walking cycle).

    Time frame: Year 1

    Stance phase will be measured with the GAITRite® Electronic Walkway.

  300. Stance phase (as a % of walking cycle).

    Time frame: Year 2

    Stance phase will be measured with the GAITRite® Electronic Walkway.

  301. Stance phase (as a % of walking cycle).

    Time frame: Year 5

    Stance phase will be measured with the GAITRite® Electronic Walkway.

  302. Vo2max (maximal oxygen consumption) (mL/Kg/min).

    Time frame: Day 0

    : Vo2max will be obtained by performing a cardiopulmonary exercise testing at maximal effort during incremental exercise on a cycle ergometer.

  303. Vo2max (maximal oxygen consumption) (mL/Kg/min).

    Time frame: Month 6

    : Vo2max will be obtained by performing a cardiopulmonary exercise testing at maximal effort during incremental exercise on a cycle ergometer.

  304. Vo2max (maximal oxygen consumption) (mL/Kg/min).

    Time frame: Year 1

    : Vo2max will be obtained by performing a cardiopulmonary exercise testing at maximal effort during incremental exercise on a cycle ergometer.

  305. Vo2max (maximal oxygen consumption) (mL/Kg/min).

    Time frame: Year 2

    : Vo2max will be obtained by performing a cardiopulmonary exercise testing at maximal effort during incremental exercise on a cycle ergometer.

  306. Vo2max (maximal oxygen consumption) (mL/Kg/min).

    Time frame: Year 5

    : Vo2max will be obtained by performing a cardiopulmonary exercise testing at maximal effort during incremental exercise on a cycle ergometer.

  307. Maximum heart rate (bpm).

    Time frame: Day 0

    Maximum heart rate will be obtained by performing a cardiopulmonary exercise testing at maximal effort during incremental exercise on a cycle ergometer.

  308. Maximum heart rate (bpm).

    Time frame: Month 6

    Maximum heart rate will be obtained by performing a cardiopulmonary exercise testing at maximal effort during incremental exercise on a cycle ergometer.

  309. Maximum heart rate (bpm).

    Time frame: Year 1

    Maximum heart rate will be obtained by performing a cardiopulmonary exercise testing at maximal effort during incremental exercise on a cycle ergometer.

  310. Maximum heart rate (bpm).

    Time frame: Year 2

    Maximum heart rate will be obtained by performing a cardiopulmonary exercise testing at maximal effort during incremental exercise on a cycle ergometer.

  311. Maximum heart rate (bpm).

    Time frame: Year 5

    Maximum heart rate will be obtained by performing a cardiopulmonary exercise testing at maximal effort during incremental exercise on a cycle ergometer.

  312. Maximum power (Watts).

    Time frame: Day 0

    Maximum power will be obtained by performing a cardiopulmonary exercise testing at maximal effort during incremental exercise on a cycle ergometer.

  313. Maximum power (Watts).

    Time frame: Month 6

    Maximum power will be obtained by performing a cardiopulmonary exercise testing at maximal effort during incremental exercise on a cycle ergometer.

  314. Maximum power (Watts).

    Time frame: Year 1

    Maximum power will be obtained by performing a cardiopulmonary exercise testing at maximal effort during incremental exercise on a cycle ergometer.

  315. Maximum power (Watts).

    Time frame: Year 2

    Maximum power will be obtained by performing a cardiopulmonary exercise testing at maximal effort during incremental exercise on a cycle ergometer.

  316. Maximum power (Watts).

    Time frame: Year 5

    Maximum power will be obtained by performing a cardiopulmonary exercise testing at maximal effort during incremental exercise on a cycle ergometer.

  317. Threshold power (Watts).

    Time frame: Day 0

    Threshold power will be obtained by performing a cardiopulmonary exercise testing at maximal effort during incremental exercise on a cycle ergometer.

  318. Threshold power (Watts).

    Time frame: Month 6

    Threshold power will be obtained by performing a cardiopulmonary exercise testing at maximal effort during incremental exercise on a cycle ergometer.

  319. Threshold power (Watts).

    Time frame: Year 1

    Threshold power will be obtained by performing a cardiopulmonary exercise testing at maximal effort during incremental exercise on a cycle ergometer.

  320. Threshold power (Watts).

    Time frame: Year 2

    Threshold power will be obtained by performing a cardiopulmonary exercise testing at maximal effort during incremental exercise on a cycle ergometer.

  321. Threshold power (Watts).

    Time frame: Year 5

    Threshold power will be obtained by performing a cardiopulmonary exercise testing at maximal effort during incremental exercise on a cycle ergometer.

  322. Threshold heart rate (bpm).

    Time frame: DAy 0

    Threshold heart will be obtained by performing a cardiopulmonary exercise testing at maximal effort during incremental exercise on a cycle ergometer.

  323. Threshold heart rate (bpm).

    Time frame: Month 6

    Threshold heart will be obtained by performing a cardiopulmonary exercise testing at maximal effort during incremental exercise on a cycle ergometer.

  324. Threshold heart rate (bpm).

    Time frame: Year 1

    Threshold heart will be obtained by performing a cardiopulmonary exercise testing at maximal effort during incremental exercise on a cycle ergometer.

  325. Threshold heart rate (bpm).

    Time frame: Year 2

    Threshold heart will be obtained by performing a cardiopulmonary exercise testing at maximal effort during incremental exercise on a cycle ergometer.

  326. Threshold heart rate (bpm).

    Time frame: Year 5

    Threshold heart will be obtained by performing a cardiopulmonary exercise testing at maximal effort during incremental exercise on a cycle ergometer.

  327. Forced vital Capacity (L).

    Time frame: Day 0

    : Forced vital Capacity will be measured with a spirometry test.

  328. Forced vital Capacity (L).

    Time frame: Month 6

    : Forced vital Capacity will be measured with a spirometry test.

  329. Forced vital Capacity (L).

    Time frame: Year 1

    : Forced vital Capacity will be measured with a spirometry test.

  330. Forced vital Capacity (L).

    Time frame: Year 2

    : Forced vital Capacity will be measured with a spirometry test.

  331. Forced vital Capacity (L).

    Time frame: Year 5

    : Forced vital Capacity will be measured with a spirometry test.

  332. Forced Expiratory volume (L)

    Time frame: Day 0

    Forced Expiratory volume will be measured with a spirometry test.

  333. Forced Expiratory volume (L)

    Time frame: Month 6

    Forced Expiratory volume will be measured with a spirometry test.

  334. Forced Expiratory volume (L)

    Time frame: Year 1

    Forced Expiratory volume will be measured with a spirometry test.

  335. Forced Expiratory volume (L)

    Time frame: Year 2

    Forced Expiratory volume will be measured with a spirometry test.

  336. Forced Expiratory volume (L)

    Time frame: Year 5

    Forced Expiratory volume will be measured with a spirometry test.

  337. Tiffeneau ratio (%).

    Time frame: Day 0

    Tiffeneau ratio will be calculated by dividing the Forced Expiratory volume to the Forced vital Capacity.

  338. Tiffeneau ratio (%).

    Time frame: Month 6

    Tiffeneau ratio will be calculated by dividing the Forced Expiratory volume to the Forced vital Capacity.

  339. Tiffeneau ratio (%).

    Time frame: Year 1

    Tiffeneau ratio will be calculated by dividing the Forced Expiratory volume to the Forced vital Capacity.

  340. Tiffeneau ratio (%).

    Time frame: Year 2

    Tiffeneau ratio will be calculated by dividing the Forced Expiratory volume to the Forced vital Capacity.

  341. Tiffeneau ratio (%).

    Time frame: Year 5

    Tiffeneau ratio will be calculated by dividing the Forced Expiratory volume to the Forced vital Capacity.

  342. Ventilatory reserve (%).

    Time frame: Day 0

    Ventilatory reserve will be obtained by performing a cardiopulmonary exercise testing at maximal effort during incremental exercise on a cycle ergometer.

  343. Ventilatory reserve (%).

    Time frame: Month 6

    Ventilatory reserve will be obtained by performing a cardiopulmonary exercise testing at maximal effort during incremental exercise on a cycle ergometer.

  344. Ventilatory reserve (%).

    Time frame: Year 1

    Ventilatory reserve will be obtained by performing a cardiopulmonary exercise testing at maximal effort during incremental exercise on a cycle ergometer.

  345. Ventilatory reserve (%).

    Time frame: Year 2

    Ventilatory reserve will be obtained by performing a cardiopulmonary exercise testing at maximal effort during incremental exercise on a cycle ergometer.

  346. Ventilatory reserve (%).

    Time frame: Year 5

    Ventilatory reserve will be obtained by performing a cardiopulmonary exercise testing at maximal effort during incremental exercise on a cycle ergometer.

  347. Physical activity

    Time frame: Day 0

    Physical activity will be measured using the Global Physical Activity Questionnaire (GPAQ)

  348. Physical activity

    Time frame: Month 6

    Physical activity will be measured using the Global Physical Activity Questionnaire (GPAQ)

  349. Physical activity

    Time frame: Year 1

    Physical activity will be measured using the Global Physical Activity Questionnaire (GPAQ)

  350. Physical activity

    Time frame: Year 2

    Physical activity will be measured using the Global Physical Activity Questionnaire (GPAQ)

  351. Physical activity

    Time frame: Year 5

    Physical activity will be measured using the Global Physical Activity Questionnaire (GPAQ)

  352. Functional capacity timed-up and go

    Time frame: Day 0

    Functional capacity will be evaluated using the Timed-Up and Go test.

  353. Functional capacity timed-up and go

    Time frame: Month 6

    Functional capacity will be evaluated using the Timed-Up and Go test.

  354. Functional capacity timed-up and go

    Time frame: Year 1

    Functional capacity will be evaluated using the Timed-Up and Go test.

  355. Functional capacity timed-up and go

    Time frame: Year 2

    Functional capacity will be evaluated using the Timed-Up and Go test.

  356. Functional capacity timed-up and go

    Time frame: Year 5

    Functional capacity will be evaluated using the Timed-Up and Go test.

  357. Functional capacity TDM6

    Time frame: Day 0

    Functional capacity will be evaluated using the 6-minute walk test.

  358. Functional capacity TDM6

    Time frame: Month 6

    Functional capacity will be evaluated using the 6-minute walk test.

  359. Functional capacity TDM6

    Time frame: Year 1

    Functional capacity will be evaluated using the 6-minute walk test.

  360. Functional capacity TDM6

    Time frame: Year 2

    Functional capacity will be evaluated using the 6-minute walk test.

  361. Functional capacity TDM6

    Time frame: Year 5

    Functional capacity will be evaluated using the 6-minute walk test.

  362. Functional capacity Five Times Sit to Stand test.

    Time frame: Day 0

    Functional capacity will be evaluated using the Five Times Sit to Stand test.

  363. Functional capacity Five Times Sit to Stand test.

    Time frame: Month 6

    Functional capacity will be evaluated using the Five Times Sit to Stand test.

  364. Functional capacity Five Times Sit to Stand test.

    Time frame: Year 1

    Functional capacity will be evaluated using the Five Times Sit to Stand test.

  365. Functional capacity Five Times Sit to Stand test.

    Time frame: Year 2

    Functional capacity will be evaluated using the Five Times Sit to Stand test.

  366. Functional capacity Five Times Sit to Stand test.

    Time frame: Year 5

    Functional capacity will be evaluated using the Five Times Sit to Stand test.

  367. Functional capacity SPPB

    Time frame: Day 0

    Functional capacity will be evaluated using the Five Times Sit to Stand test.Functional capacity will be evaluated using the Short Physical Performance Battery test.

  368. Functional capacity SPPB

    Time frame: Month 6

    Functional capacity will be evaluated using the Five Times Sit to Stand test.Functional capacity will be evaluated using the Short Physical Performance Battery test.

  369. Functional capacity SPPB

    Time frame: Year 1

    Functional capacity will be evaluated using the Five Times Sit to Stand test.Functional capacity will be evaluated using the Short Physical Performance Battery test.

  370. Functional capacity SPPB

    Time frame: Year 2

    Functional capacity will be evaluated using the Five Times Sit to Stand test.Functional capacity will be evaluated using the Short Physical Performance Battery test.

  371. Functional capacity SPPB

    Time frame: Year 5

    Functional capacity will be evaluated using the Five Times Sit to Stand test.Functional capacity will be evaluated using the Short Physical Performance Battery test.

  372. Functional capacity the mini-BESTest.

    Time frame: Day 0

    Functional capacity will be evaluated using the mini-BESTest.

  373. Functional capacity the mini-BESTest.

    Time frame: Month 6

    Functional capacity will be evaluated using the mini-BESTest.

  374. Functional capacity the mini-BESTest.

    Time frame: Year 1

    Functional capacity will be evaluated using the mini-BESTest.

  375. Functional capacity the mini-BESTest.

    Time frame: Year 2

    Functional capacity will be evaluated using the mini-BESTest.

  376. Functional capacity the mini-BESTest.

    Time frame: Year 5

    Functional capacity will be evaluated using the mini-BESTest.

  377. Functional capacity Berg Balance Scale.

    Time frame: Day 0

    Functional capacity will be evaluated using the Berg Balance Scale.

  378. Functional capacity Berg Balance Scale.

    Time frame: Month 6

    Functional capacity will be evaluated using the Berg Balance Scale.

  379. Functional capacity Berg Balance Scale.

    Time frame: Year 1

    Functional capacity will be evaluated using the Berg Balance Scale.

  380. Functional capacity Berg Balance Scale.

    Time frame: Year 2

    Functional capacity will be evaluated using the Berg Balance Scale.

  381. Functional capacity Berg Balance Scale.

    Time frame: Year 5

    Functional capacity will be evaluated using the Berg Balance Scale.

  382. Functional capacity 10-meter walk test

    Time frame: Day 0

    Functional capacity will be evaluated using the 10-meter walk test (at usual and maximal pace).

  383. Functional capacity 10-meter walk test

    Time frame: Month 6

    Functional capacity will be evaluated using the 10-meter walk test (at usual and maximal pace).

  384. Functional capacity 10-meter walk test

    Time frame: Year 1

    Functional capacity will be evaluated using the 10-meter walk test (at usual and maximal pace).

  385. Functional capacity 10-meter walk test

    Time frame: Year 2

    Functional capacity will be evaluated using the 10-meter walk test (at usual and maximal pace).

  386. Functional capacity 10-meter walk test

    Time frame: Year 5

    Functional capacity will be evaluated using the 10-meter walk test (at usual and maximal pace).

  387. Dyspnea

    Time frame: Day 0

    Dyspnea will be evaluated by a Numeric Rating scale ranging from 0 to 10.

  388. Dyspnea

    Time frame: Month 6

    Dyspnea will be evaluated by a Numeric Rating scale ranging from 0 to 10.

  389. Dyspnea

    Time frame: Year 1

    Dyspnea will be evaluated by a Numeric Rating scale ranging from 0 to 10.

  390. Dyspnea

    Time frame: Year 2

    Dyspnea will be evaluated by a Numeric Rating scale ranging from 0 to 10.

  391. Dyspnea

    Time frame: Year 5

    Dyspnea will be evaluated by a Numeric Rating scale ranging from 0 to 10.

  392. Perceived exertion before, during and after effort

    Time frame: DAy 0

    Perceived exertion will be evaluated by a Numeric Rating scale ranging from 0 to 10.

  393. Perceived exertion before, during and after effort

    Time frame: Month 6

    Perceived exertion will be evaluated by a Numeric Rating scale ranging from 0 to 10.

  394. Perceived exertion before, during and after effort

    Time frame: Year 1

    Perceived exertion will be evaluated by a Numeric Rating scale ranging from 0 to 10.

  395. Perceived exertion before, during and after effort

    Time frame: Year 2

    Perceived exertion will be evaluated by a Numeric Rating scale ranging from 0 to 10.

  396. Perceived exertion before, during and after effort

    Time frame: Year 5

    Perceived exertion will be evaluated by a Numeric Rating scale ranging from 0 to 10.

  397. Pain

    Time frame: Day 0

    : Pain will be measured by a visual analogue scale (VAS) ranging from 0 to 10 and possibly as appropriate by other questionnaires or specific scales.

  398. Pain

    Time frame: Month 6

    : Pain will be measured by a visual analogue scale (VAS) ranging from 0 to 10 and possibly as appropriate by other questionnaires or specific scales.

  399. Pain

    Time frame: Year 1

    : Pain will be measured by a visual analogue scale (VAS) ranging from 0 to 10 and possibly as appropriate by other questionnaires or specific scales.

  400. Pain

    Time frame: Year 2

    : Pain will be measured by a visual analogue scale (VAS) ranging from 0 to 10 and possibly as appropriate by other questionnaires or specific scales.

  401. Pain

    Time frame: Year 5

    : Pain will be measured by a visual analogue scale (VAS) ranging from 0 to 10 and possibly as appropriate by other questionnaires or specific scales.

  402. Sarcopenia risk

    Time frame: Day 0

    Sarcopenia risk will be evaluated with the SARC-F Questionnaire.

  403. Sarcopenia risk

    Time frame: Month 6

    Sarcopenia risk will be evaluated with the SARC-F Questionnaire.

  404. Sarcopenia risk

    Time frame: Year 1

    Sarcopenia risk will be evaluated with the SARC-F Questionnaire.

  405. Sarcopenia risk

    Time frame: Year 2

    Sarcopenia risk will be evaluated with the SARC-F Questionnaire.

  406. Sarcopenia risk

    Time frame: Year 5

    Sarcopenia risk will be evaluated with the SARC-F Questionnaire.

  407. Social insecurity

    Time frame: Day 0

    Social insecurity will be evaluated with the EPICES Score Questionnaire.

  408. Social insecurity

    Time frame: Month 6

    Social insecurity will be evaluated with the EPICES Score Questionnaire.

  409. Social insecurity

    Time frame: Year 1

    Social insecurity will be evaluated with the EPICES Score Questionnaire.

  410. Social insecurity

    Time frame: Year 2

    Social insecurity will be evaluated with the EPICES Score Questionnaire.

  411. Social insecurity

    Time frame: Year 5

    Social insecurity will be evaluated with the EPICES Score Questionnaire.

  412. Kinesiophobia

    Time frame: Day 0

    Kinesiophobia will be evaluated with the TAMPA Scale.

  413. Kinesiophobia

    Time frame: Month 6

    Kinesiophobia will be evaluated with the TAMPA Scale.

  414. Kinesiophobia

    Time frame: Year 1

    Kinesiophobia will be evaluated with the TAMPA Scale.

  415. Kinesiophobia

    Time frame: Year 2

    Kinesiophobia will be evaluated with the TAMPA Scale.

  416. Kinesiophobia

    Time frame: Year 5

    Kinesiophobia will be evaluated with the TAMPA Scale.

  417. Quality of life

    Time frame: Day 0

    Quality of life will be evaluated with the 36-Item Short Form Survey.

  418. Quality of life

    Time frame: Month 6

    Quality of life will be evaluated with the 36-Item Short Form Survey.

  419. Quality of life

    Time frame: Year 1

    Quality of life will be evaluated with the 36-Item Short Form Survey.

  420. Quality of life

    Time frame: Year 2

    Quality of life will be evaluated with the 36-Item Short Form Survey.

  421. Quality of life

    Time frame: Year 5

    Quality of life will be evaluated with the 36-Item Short Form Survey.

  422. : Balance confidence in performing various activities

    Time frame: Day 0

    Self-report balance confidence will be evaluated with the Activities-specific Balance Confidence (ABC) Scale.vey.

  423. : Balance confidence in performing various activities

    Time frame: Month 6

    Self-report balance confidence will be evaluated with the Activities-specific Balance Confidence (ABC) Scale.vey.

  424. : Balance confidence in performing various activities

    Time frame: Year 1

    Self-report balance confidence will be evaluated with the Activities-specific Balance Confidence (ABC) Scale.vey.

  425. : Balance confidence in performing various activities

    Time frame: Year 2

    Self-report balance confidence will be evaluated with the Activities-specific Balance Confidence (ABC) Scale.vey.

  426. : Balance confidence in performing various activities

    Time frame: Year 5

    Self-report balance confidence will be evaluated with the Activities-specific Balance Confidence (ABC) Scale.vey.

  427. Functioning in regards to activities of daily living.

    Time frame: Day 0

    Functioning will be evaluated with the Lawton Instrumental Activities of Daily Living (IADL) Scale.

  428. Functioning in regards to activities of daily living.

    Time frame: Month 6

    Functioning will be evaluated with the Lawton Instrumental Activities of Daily Living (IADL) Scale.

  429. Functioning in regards to activities of daily living.

    Time frame: Year 1

    Functioning will be evaluated with the Lawton Instrumental Activities of Daily Living (IADL) Scale.

  430. Functioning in regards to activities of daily living.

    Time frame: Year 2

    Functioning will be evaluated with the Lawton Instrumental Activities of Daily Living (IADL) Scale.

  431. Functioning in regards to activities of daily living.

    Time frame: Year 5

    Functioning will be evaluated with the Lawton Instrumental Activities of Daily Living (IADL) Scale.

  432. Exhaustion

    Time frame: Day 0

    Exhaustion will be evaluated with the FACIT-F Questionnaire.

  433. Exhaustion

    Time frame: Month 6

    Exhaustion will be evaluated with the FACIT-F Questionnaire.

  434. Exhaustion

    Time frame: Year 1

    Exhaustion will be evaluated with the FACIT-F Questionnaire.

  435. Exhaustion

    Time frame: Year 2

    Exhaustion will be evaluated with the FACIT-F Questionnaire.

  436. Exhaustion

    Time frame: Year 5

    Exhaustion will be evaluated with the FACIT-F Questionnaire.

  437. Patient's opinion about their knee and associated problems

    Time frame: Day 0

    : Outcomes will be evaluated with the Knee Injury and Osteoarthritis Outcome Score (KOOS).

  438. Patient's opinion about their knee and associated problems

    Time frame: Month 6

    : Outcomes will be evaluated with the Knee Injury and Osteoarthritis Outcome Score (KOOS).

  439. Patient's opinion about their knee and associated problems

    Time frame: Year 1

    : Outcomes will be evaluated with the Knee Injury and Osteoarthritis Outcome Score (KOOS).

  440. Patient's opinion about their knee and associated problems

    Time frame: Year 2

    : Outcomes will be evaluated with the Knee Injury and Osteoarthritis Outcome Score (KOOS).

  441. Patient's opinion about their knee and associated problems

    Time frame: Year 5

    : Outcomes will be evaluated with the Knee Injury and Osteoarthritis Outcome Score (KOOS).

  442. Patient's opinion about their hip and associated problems

    Time frame: Day 0

    Outcomes will be evaluated with the Hip Injury and Osteoarthritis Outcome Score (HOOS).

  443. Patient's opinion about their hip and associated problems

    Time frame: Month 6

    Outcomes will be evaluated with the Hip Injury and Osteoarthritis Outcome Score (HOOS).

  444. Patient's opinion about their hip and associated problems

    Time frame: Year 1

    Outcomes will be evaluated with the Hip Injury and Osteoarthritis Outcome Score (HOOS).

  445. Patient's opinion about their hip and associated problems

    Time frame: Year 2

    Outcomes will be evaluated with the Hip Injury and Osteoarthritis Outcome Score (HOOS).

  446. Patient's opinion about their hip and associated problems

    Time frame: Year 5

    Outcomes will be evaluated with the Hip Injury and Osteoarthritis Outcome Score (HOOS).

  447. Predicting discharge destination after total joint arthroplasty.

    Time frame: Day 0

    : Discharge destination will be evaluated with the Risk Assessment and Prediction Tool (RAPT);

  448. Predicting discharge destination after total joint arthroplasty.

    Time frame: Month 6

    : Discharge destination will be evaluated with the Risk Assessment and Prediction Tool (RAPT);

  449. Physical function in myositis patients

    Time frame: Day 0

    Physical function will be evaluated with the Stanford Health Assessment Questionnaire.

  450. Physical function in myositis patients

    Time frame: Month 6

    Physical function will be evaluated with the Stanford Health Assessment Questionnaire.

  451. Physical function in myositis patients

    Time frame: Year 1

    Physical function will be evaluated with the Stanford Health Assessment Questionnaire.

  452. Physical function in myositis patients

    Time frame: Year 2

    Physical function will be evaluated with the Stanford Health Assessment Questionnaire.

  453. Physical function in myositis patients

    Time frame: Year 5

    Physical function will be evaluated with the Stanford Health Assessment Questionnaire.

  454. Quality of life in Parkinson's Disease

    Time frame: Day 0

    Quality of life will be measured with the Parkinson's Disease Questionnaire-39 (PDQ-39).

  455. Quality of life in Parkinson's Disease

    Time frame: Month 6

    Quality of life will be measured with the Parkinson's Disease Questionnaire-39 (PDQ-39).

  456. Quality of life in Parkinson's Disease

    Time frame: Year 1

    Quality of life will be measured with the Parkinson's Disease Questionnaire-39 (PDQ-39).

  457. Quality of life in Parkinson's Disease

    Time frame: Year 2

    Quality of life will be measured with the Parkinson's Disease Questionnaire-39 (PDQ-39).

  458. Quality of life in Parkinson's Disease

    Time frame: Year 5

    Quality of life will be measured with the Parkinson's Disease Questionnaire-39 (PDQ-39).

  459. Actimetry.

    Time frame: during 5 consecutive days after day 0

    Actimetry data (energy expenditure, number of steps, sedentary time, total physical activity, etc.) will be obtained with the WGT3X-BT Actigraph inertial sensor unit.

Study contacts

Contact information is provided by the study sponsor or research team.

Lise Laclautre

CONTACT

[email protected]

334.73.754.963

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Collaborators

  • I-SITE Cap 20-25 project

Registry information

Acronym: EVALMOB

Important dates

Study start
2020
Primary completion
2035
Study completion
2035
First posted
May 5, 2020
Registry last updated
May 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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