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NCT Number: NCT06309342

Prevention of Lifestyle-related Disorders Based on Functional Examinations

The goal of this randomised controlled trial is to examine the effects of functional examinations and feedback/support on healthy 40-year-olds. The main questions it aims to answer are: • Does feedback and motivational interviewing after testing physical function motivate inactive middle-aged people to increase their physical activity level? • Does the intervention lead to health benefits over time - less pain, better function, higher health-related quality of life, fewer risk factors for lifestyle-related illness? Participants will: • undergo medical and functional health examinations, • their physical activity level will be measured, • receive feedback and advice based on both parts of the examinations, • receive a functional profile, • be supported in goalsetting for lifestyle changes. Researchers will compare with a control group who, after the examinations, receive feedback only from the medical examination to see if participants become more physically active, achieve better function, become more motivated to make lifestyle changes, reduce risk factors for lifestyle-related illness, achieve health benefits and better health-related quality of life.

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Key information

Age range

39 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

Relatively healthy 40-year-olds will be examined at baseline and 1 year with both standard medical and newly developed functional examinations and physical activity level will be measured with accelerometers. The intervention group will receive feedback on all their results. A functional profile will be compiled and explained to each participant and they will receive support in setting relevant goals for lifestyle changes and making realistic plans to achieve them. The control group will also be examined as above but will receive feedback and advice based only on the standard medical examination.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 40 years of age
  • Relatively normal general mobility - can walk without support and have no self-reported difficulties with using all four extremities - in order to be able to perform standardised functional performance tests.
  • Self-assessed as physically inactive (level 1 or 2 on the Saltin Grimby Physical Activity Level Scale) as inactive people stand to gain most from this intervention.

Exclusion criteria

  • Verbally self-reported physical activity at level three or four on Saltin Grimby Physical Activity Level Scale.
  • Severe mental illness or intellectual impairment, as participants will be expected to fill out questionnaires and should have the ability to follow healthcare advice independently should they choose to do so.
  • Pregnancy and/or on-going treatment requiring hospital-based services, to increase probability of baseline values which reflect usual capacity.
  • No language restrictions are planned but participants needing interpreter help should arrange this themselves.

Treatment and study plan

PREVFUNKTION

Other

Functional profile and advice concerning cardiovascular fitness level, strength, mobility, balance and posture. Motivational interview and support in goalsetting to make lifestyle changes.

Control

Other

Physical activity measured with accelerometers. Functional examination. Medical examination and advice concerning weight measures, blood pressure and standard blood tests.

Primary outcomes

  1. Change in objectively measured physical activity

    Time frame: Change between baseline and 1-year follow-up

    Mean daily minutes in moderate-to-very vigorous physical activity measured with accelerometers for 1 week

  2. Change in objectively measured sedentary behaviour

    Time frame: Change between baseline and 1-year follow-up

    Mean daily minutes of sedentary behaviour measured with accelerometers for 1 week

Secondary outcomes

  1. Change in cardiovascular fitness

    Time frame: Change between baseline and 1-year follow-up

    Fitness level measured in ml/kg/min using the Ekblom Bak submaximal ergometer test

  2. Change in motivation level

    Time frame: Change between baseline and 1-year follow-up

    Motivation to make lifestyle changes to improve health on an 11-point numerical rating scale.

  3. Proportion achieved goals

    Time frame: Measured only at 1-year follow-up

    Proportion of goals achieved of the goals set by the intervention group at baseline

  4. Change in fitness level

    Time frame: Change between baseline and 1-year follow-up

    Point level on the study-specific functional profile arm for fitness where points are given for grade of deviation from norm. Minimum -2, maximum +2. Higher scores indicate better fitness level.

  5. Change in strength upper extremity

    Time frame: Change between baseline and 1-year follow-up

    Point level on the study-specific functional profile arm for strength upper extremity where points are given for grade of deviation from norm. Minimum -2, maximum +2. Higher scores indicate better strength.

  6. Change in strength lower extremity

    Time frame: Change between baseline and 1-year follow-up

    Point level on the study-specific functional profile arm for strength lower extremity where points are given for grade of deviation from norm. Minimum -2, maximum +2. Higher scores indicate better strength.

  7. Change in strength trunk muscles

    Time frame: Change between baseline and 1-year follow-up

    Point level on the study-specific functional profile arm for strength trunk where points are given for grade of deviation from norm. Minimum -2, maximum +2. Higher scores indicate better strength.

  8. Change in balance

    Time frame: Change between baseline and 1-year follow-up

    Point level on the study-specific functional profile arm for balance where points are given for grade of deviation from norm. Minimum -2, maximum +2. Higher scores indicate better balance.

  9. Change in mobility

    Time frame: Change between baseline and 1-year follow-up

    Point level on the study-specific functional profile arm for mobility where points are given for grade of deviation from norm. Minimum -2, maximum 0. Lower score indicates mobility dysfunction, 0 indicates normal mobility.

  10. Change in posture

    Time frame: Change between baseline and 1-year follow-up

    Point level on the study-specific functional profile arm for posture where points are given for grade of deviation from norm. Minimum -1, maximum 0. Lower score indicates postural deviations, 0 indicates normal postural measurements.

  11. Change in weight measures

    Time frame: Change between baseline and 1-year follow-up

    Point level on the study-specific functional profile arm for weight where points are given for grade of deviation from recommended values. Minimum -2, maximum 0. Lower score indicates overweight (or underweight), 0 indicates normal weight.

  12. Change in pain

    Time frame: Change between baseline and 1-year follow-up

    Point level on the study-specific functional profile arm for pain where points are given for number of pain locations, score on the Örebro Musculoskeletal Pain Screening Questionnaire and on the pain question on Euroqol-5 dimensions-3 levels. Minimum -2, maximum 0. Lower score indicates more pain, 0 indicates no pain.

  13. Change in physical activity

    Time frame: Change between baseline and 1-year follow-up

    Point level on the study-specific functional profile arm for physical activity where points are given for grade of deviation from recommended values when objectively measured with accelerometers. Minimum -2, maximum +2. Increased point value indicates higher physical activity level.

  14. Change in handgrip strength

    Time frame: Change between baseline and 1-year follow-up

    Measured with Jamar handdynamometer (kg)

  15. Change in biceps strength

    Time frame: Change between baseline and 1-year follow-up

    Measured with 30-second biceps test (number repetitions)

  16. Change in leg strength

    Time frame: Change between baseline and 1-year follow-up

    Measured with 30-second chair-stand test (number repetitions)

  17. Change in calf strength

    Time frame: Change between baseline and 1-year follow-up

    Measured with single-foot heel rises (number repetitions)

  18. Change in ventral trunk strength

    Time frame: Change between baseline and 1-year follow-up

    Measured with plank test (seconds)

  19. Change in dorsal trunk strength

    Time frame: Change between baseline and 1-year follow-up

    Measured with back endurance test (seconds)

  20. Change in lower trunk strength

    Time frame: Change between baseline and 1-year follow-up

    Measured with supine bridge test (seconds)

  21. Change in static balance - 1

    Time frame: Change between baseline and 1-year follow-up

    Measured with stand-on-one-leg-eyes-open test (seconds)

  22. Change in static balance - 2

    Time frame: Change between baseline and 1-year follow-up

    Measured with stand-on-one-leg-eyes-closed test (seconds)

  23. Change in static balance - 3

    Time frame: Change between baseline and 1-year follow-up

    Measured with sharpened Romberg test (seconds)

  24. Change in dynamic balance

    Time frame: Change between baseline and 1-year follow-up

    Measured with functional reach test (centimeters)

  25. Change in mobility - 1

    Time frame: Change between baseline and 1-year follow-up

    Measured with sit-rise test (points)

  26. Change in mobility - 2

    Time frame: Change between baseline and 1-year follow-up

    Measured with finger-floor test (centimeters)

  27. Change in mobility - 3

    Time frame: Change between baseline and 1-year follow-up

    Measured with lateral flexion test (centimeters)

  28. Change in hypermobility score

    Time frame: Change between baseline and 1-year follow-up

    Measured with Beighton hypermobility score with point values between 0 and 9 where score over 4 indicate general hypermobility.

  29. Change in neck mobility

    Time frame: Change between baseline and 1-year follow-up

    Measured with occiput-to-wall test (points)

  30. Change in foot pronation

    Time frame: Change between baseline and 1-year follow-up

    Measured with navicular drop test (millimeters)

  31. Change in habitual stance

    Time frame: Change between baseline and 1-year follow-up

    Measured with patella mobility test (points)

  32. Change in health-related quality of life assessed with EQ5D index

    Time frame: Change between baseline and 1-year follow-up

    Measured with index values for Euroqol-5 dimensions-3 levels. Minimum -0.59, maximum +1. Higher scores indicate better health-related quality of life.

  33. Change in health-related quality of life assessed with EQ5D VAS

    Time frame: Change between baseline and 1-year follow-up

    Measured with the 100-point barometer for Euroqol-5 dimensions-3 levels. Minimum 0, maximum 100. Higher scores indicate better health-related quality of life.

  34. Change in self-reported physical activity assessed with Swedish questionnaire

    Time frame: Change between baseline and 1-year follow-up

    Measured with Swedish National Board of Health and Welfare questionnaire with 2 questions on physical activity and exercise measured in minutes. Minimum 0, maximum measured value 540. Increasing values indicate higher levels of physical activity.

  35. Change in self-reported physical activity assessed with Saltin Grimby Physical Activity Level Scale (SGPALS)

    Time frame: Change between baseline and 1-year follow-up

    Measured with SGPALS with point values between 1 and 4 where increasing values indicate higher level of physical activity.

  36. Change in self-reported sedentary time

    Time frame: Change between baseline and 1-year follow-up

    Measured in hours per day with SED-GIH questionnaire with values between 0 and 24 where increasing sedentary time is considered to have a negative impact on health.

  37. Change in risk for chronic pain and sickness absence assessed with Örebro Musculoskeletal Pain Screening Questionnaire

    Time frame: Change between baseline and 1-year follow-up

    Measured with Örebro Musculoskeletal Pain Screening Questionnaire with scores between 1 and 100 where increasing values indicate higher risk for chronic pain and sickness absence.

  38. Change in number of pain locations

    Time frame: Change between baseline and 1-year follow-up

    Measured with a pain diagram

  39. Change in proportion smokers

    Time frame: Change between baseline and 1-year follow-up

    Proportion smokers in each group

  40. Change in proportion acceptable level blood glucose

    Time frame: Change between baseline and 1-year follow-up

    Proportion with blood glucose levels within recommended limits (4.0-6.0 mmol/L)

  41. Change in proportion acceptable level serum cholesterol

    Time frame: Change between baseline and 1-year follow-up

    Proportion with cholesterol levels within recommended limits (3.3-6.9 mmol/L)

  42. Change in proportion acceptable level triglycerides

    Time frame: Change between baseline and 1-year follow-up

    Proportion with triglyceride levels within recommended limits (0,45-2.6)

  43. Change in proportion acceptable blood pressure

    Time frame: Change between baseline and 1-year follow-up

    Proportion of participants with blood pressure within recommended limits

  44. Change in proportion normal body mass index (BMI)

    Time frame: Change between baseline and 1-year follow-up

    Proportion of participants with BMI within recommended limits

  45. Change in proportion acceptable waist circumference

    Time frame: Change between baseline and 1-year follow-up

    Proportion of participants with waist circumference below recommended level

  46. Change in stress symptoms assessed with Stress and Crisis Inventory-93

    Time frame: Change between baseline and 1-year follow-up

    Measured with Stress and Crisis Inventory-93 questionnaire. Minimum 0, maximum 140, with higher values indicating higher stress levels.

  47. Change in depression and anxiety symptoms assessed with Hospital Anxiety and Depression Scale

    Time frame: Change between baseline and 1-year follow-up

    Measured with Hospital Anxiety and Depression Scale. Minimum 0, maximum 42 with 21 as maximum for anxiety and 21 maximum for depression. Increasing values indicate more severe symptoms.

  48. Correlation between self-assessed and objectively measured fitness

    Time frame: Change between baseline and 1-year follow-up

    Correlation between fitness self-assessed on a 5-point Likert scale and point value on the fitness arm on the study-specific functional profile. Minimum -1, maximum +1. Higher values indicate better correlation between the 2 measures.

  49. Correlation between self-assessed and objectively measured fitness - 2

    Time frame: Change between baseline and 1-year follow-up

    Correlation between fitness self-assessed on a 5-point Likert scale and fitness grade on the Ekblom Bak fitness test (5 point Likert scale). Minimum -1, maximum +1. Higher values indicate better correlation between the 2 measures.

  50. Correlation between self-assessed and objectively measured strength upper extremity

    Time frame: Change between baseline and 1-year follow-up

    Correlation between upper extremity strength self-assessed on a 5-point Likert scale and point value for the strength upper extremity arm on the study-specific functional profile. Minimum -1, maximum +1. Higher values indicate better correlation between the 2 measures.

  51. Correlation between self-assessed and objectively measured strength lower extremity

    Time frame: Change between baseline and 1-year follow-up

    Correlation between lower extremity strength self-assessed on a 5-point Likert scale and point value for the strength lower extremity arm on the study-specific functional profile. Minimum -1, maximum +1. Higher values indicate better correlation between the 2 measures.

  52. Correlation between self-assessed and objectively measured balance

    Time frame: Change between baseline and 1-year follow-up

    Correlation between balance self-assessed on a 5-point Likert scale and point value on the balance arm on the study-specific functional profile. Minimum -1, maximum +1. Higher values indicate better correlation between the 2 measures.

  53. Correlation between self-assessed and objectively measured physical activity

    Time frame: Change between baseline and 1-year follow-up

    Correlation between self-assessed walking ability on a 5-point Likert scale and point value on the physical activity arm on the study-specific functional profile. Minimum -1, maximum +1. Higher values indicate better correlation between the 2 measures.

  54. Correlation between self-assessed and objectively measured physical activity - 2

    Time frame: Change between baseline and 1-year follow-up

    Correlation between self-assessed walking ability on a 5-point Likert scale and number of daily minutes in moderate-to-very vigorous physical activity measured with accelerometers. Minimum -1, maximum +1. Higher values indicate better correlation between the 2 measures.

  55. Change in relative physical activity

    Time frame: Change between baseline and 1-year follow-up

    Mean daily minutes of moderate-to-very vigorous physical activity measured with accelerometers for 1 week where moderate is individually calculated in relation to fitness level (46% of VO2max).

  56. Change in sufficient physical activity

    Time frame: Change between baseline and 1-year follow-up

    Number of mean daily minutes of physical activity measured with accelerometers for 1 week above a known health-promoting level based on a fitness level of 31.5 ml/kg for women and 35 ml/kg for men.

Study contacts

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

Lena Bornhöft, PhD

CONTACT

[email protected]

+46 761408320

Sponsors and collaborators

Lead sponsor

Lena Bornhoft

Other

Collaborators

  • Göteborg University
  • Vastra Gotaland Region

Registry information

Official study title

Prevention of Lifestyle-related Disorders With Early Examinations of Health and Function and Individualised Functional Profiles - a Randomised Controlled Trial

Acronym: PREVFUNKTION

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 13, 2024
Registry last updated
Oct 8, 2024

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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