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NCT Number: NCT05918159

Effects of Sarcopenia on General Health Status in Elderly: a Population-based Study

This is a observational study, that aimed to determine the prevalence of sarcopenia using European Wording Group on Sarcopenia in Older People (EWGSOP) algorithm in a general elderly population in Algarve region (Portugal). Because muscle is metabolically active tissue, sarcopenia may also contribute to the development of some of the metabolic disorders associated with aging. However, the risk factors associated with sarcopenia are poorly understood. Thus, a cross-sectional survey of a sample of 274 elderly adults aged 60 or over, were included in the study. Correlations of sarcopenia with functional level, lipid and glycemic profile, nutritional and physical activity level, fall risk, quality of life, and self-reported comorbidities will be studied.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Marta Botelho

Faro, Algarve, 8005-139, Portugal

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Minimum age of 60 years;
  • Live in the community;
  • Independet Gait.

Exclusion criteria

  • Presence of moderate or severe cognitive impairment;
  • Presence of uncontrolled cardiovascular disease and active cancer;
  • Use of a pacemaker;
  • Use of internal prosthesis.

Treatment and study plan

Sarcopenia Assessment

Other

The prevalence of sarcopenia in a group of elderly people and its correlation with other health variables was determined.

Primary outcomes

  1. Prevalence of Sarcopenia in elderly population

    Time frame: 0 Months

    Determine the prevalence of sarcopenia using European Wording Group on Sarcopenia in Older People (EWGSOP) algorithm in a general elderly population in Algarve region.

  2. Quality of life in elderly population

    Time frame: 0 Months

    Quality of life was assessed at one time point only (due to the nature of the cross-sectional study design) using the subscore and total score of Medical Outcomes Study 36-item Short-Form Health Survey instrument. Instrument scores can range between 0 - 100. Higher values mean better self-perception of quality of life.

Secondary outcomes

  1. Cognitive Assessment

    Time frame: 0 Months

    Cognitive Assessment was assessed by the instrument Montreal Cognitive Assessment (MoCA). Instrument with a maximum score of 30 points, where higher scores mean better cognitive performance.

  2. Body mass index (kg/m2) - body composition

    Time frame: 0 Months

    Body mass index (kg/m2) was measured using the bioimpedance technique.

  3. Fat Mass (kg and %) - body composition

    Time frame: 0 Months

    Fat Mass (kg and %) was measured using the bioimpedance technique.

  4. Fat-Free Mass (kg and %) - body composition

    Time frame: 0 Months

    Fat-Free Mass (kg and %) was measured using the bioimpedance technique.

  5. Fat Mass Index (kg/m2) - body composition

    Time frame: 0 Months

    Fat Mass Index (kg/m2) was measured using the bioimpedance technique.

  6. Fat-Free Mass Index (kg/m2) - body composition

    Time frame: 0 Months

    Fat-Free Mass Index (kg/m2) was measured using the bioimpedance technique.

  7. Muscle Mass Index (kg/m2) - body composition

    Time frame: 0 Months

    Muscle Mass Index (kg/m2) was measured using the bioimpedance technique.

  8. Total body water (L and %) - body composition

    Time frame: 0 Months

    Total body water (L and %) was measured using the bioimpedance technique.

  9. Resistence (Ohms) - body composition

    Time frame: 0 Months

    Resistence (Ohms) was measured using the bioimpedance technique.

  10. Reactance (Ohms) - body composition

    Time frame: 0 Months

    Reactance (Ohms) was measured using the bioimpedance technique.

  11. Phase angle (angle) - body composition

    Time frame: 0 Months

    Phase angle was measured using the bioimpedance technique.

  12. Visceral fat (L) - body composition

    Time frame: 0 Months

    Visceral fat (L) was measured using the bioimpedance technique.

  13. High-density lipoprotein (HDL) cholesterol (mg/dL) - Lipid Profile

    Time frame: 0 Months

    High-density lipoprotein (HDL) cholesterol (mg/dL) was measured taking a sample blood which was analysed by the COBAS b 101 system.

  14. Low-density lipoprotein (LDL) cholesterol (mg/dL) - Lipid Profile

    Time frame: 0 Months

    Low-density lipoprotein (HDL) cholesterol (mg/dL) was measured taking a sample blood which was analysed by the COBAS b 101 system.

  15. Triglycerides (mg/dL) - Lipid Profile

    Time frame: 0 Months

    Triglycerides (mg/dL) was measured taking a sample blood which was analysed by the COBAS b 101 system.

  16. Total cholesterol (mg/dL) - Lipid Profile

    Time frame: 0 Months

    Total cholesterol (mg/dL) was measured taking a sample blood which was analysed by the COBAS b 101 system.

  17. Glicemic Profile in elderly

    Time frame: 0 Months

    Glicemic Profile was measured by COBAS b 101 system, taking a sample blood which was analysed for Glycated Hemoglobin (HbA1c).

  18. Inflammatory levels in elderly population

    Time frame: 0 Months

    Inflammatory levels was measured by COBAS b 101 system, taking a sample blood which was analysed for C-reactive protein - CRP.

  19. Nutritional level in elderly population

    Time frame: 0 Months

    Nutrional level was assessed at one time point only (due to the nature of the cross-sectional study design) using a questionnaire Mini Nutritional Assessment. Instrument scores can range between 0 - 30. The cutoff points used were: 0-7 points - malnourished; 8-11 points - at risk of malnutrition; 12-24 points - normal nutritional status.

  20. Postural Stability in elderly population

    Time frame: 0 Months

    Postural stability was assessed by a force platform using the length displacement of center of pressure.

  21. Peak Torque (N/m) of Quadriceps and Hamstring Muscles

    Time frame: 0 Months

    Peak Torque of Quadriceps and Hamstring Muscles was measured by afixed dynamometer with concentric/concentric action at an angular velocity of 60º per second for 5 repetitions of extension and flexion of each knee.

  22. Work (N/m) of Quadriceps and Hamstring Muscles

    Time frame: 0 Months

    Work of Quadriceps and Hamstring Muscles was measured by afixed dynamometer with concentric/concentric action at an angular velocity of 60º per second for 5 repetitions of extension and flexion of each knee.

  23. Power (N/m) of Quadriceps and Hamstring Muscles

    Time frame: 0 Months

    Power of Quadriceps and Hamstring Muscles was measured by afixed dynamometer with concentric/concentric action at an angular velocity of 60º per second for 5 repetitions of extension and flexion of each knee.

  24. Peak torque time (s) of Quadriceps and Hamstring Muscles

    Time frame: 0 Months

    Peak torque time of Quadriceps and Hamstring Muscles was measured by afixed dynamometer with concentric/concentric action at an angular velocity of 60º per second for 5 repetitions of extension and flexion of each knee.

  25. Force (kg) of Quadriceps and Hamstring Muscles

    Time frame: 0 Months

    Force of Quadriceps and Hamstring Muscles was measured by afixed dynamometer with concentric/concentric action at an angular velocity of 60º per second for 5 repetitions of extension and flexion of each knee.

  26. Time up and Go (TUG) test - Fall risk in elderly population

    Time frame: 0 Months

    TUG test measures (in seconds) the time a person needs to rise from a chair with armrests, to walk the distance of 3 m with usual assistive devices, if necessary, turn, return to the chair, and sit down. TUG test is a composite measure of functional mobility. It includes transfer tasks (standing up and sitting down), walking, and turning, thus incorporating neuromuscular components such as power, agility, and balance. Faster test completion signals better dexterity and functional state, whereas the score of ≥13.5 was used as a cut-off point to identify the elderly individuals who are at risk for falls in community dwelling.

  27. Modified Falls Efficacy Scale (MFES) - Fall risk in elderly population

    Time frame: 0 Months

    The Modified Falls Efficacy Scale (MFES) consists of 14 items to be subjectively evaluated on a scale of 1 to 5 in terms of confidence in the ability of a person to perform daily indoor and outdoor activities without falling. Higher values represent less risk of falling.

  28. Physical Activity level in elderly population

    Time frame: 0 Months

    Physical activity level was assessed at one time point only (due to the nature of the cross-sectional study design) using the questionnaire PASE - Physical Activity Scale for Elderly. The PASE measures the level of self-reported physical activity in individuals aged 65 years or older and is comprised of items regarding occupational, household, and leisure activities during the previous 7-day period. It was used frequency, duration, and intensity level of activity over the previous week to assign a score, ranging from 0 to 793, with higher scores indicating greater physical activity.

  29. Pain associated with osteoarthritis

    Time frame: 0 Months

    Pain associated with osteoarthritis was mesured by Western Ontario and McMaster Universities Arthritis Index (WOMAC Index) - subscore pain. This instrument is widely used in the evaluation of Hip and Knee Osteoarthritis. It is a self-administered questionnaire consisting of 24 items divided into 3 subscales: Pain (5 items), Stiffness (2 items), and Physical Function (17 items). The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. Higher scores indicate worse pain, stiffness, and functional limitations.

  30. Stiffness associated with osteoarthritis

    Time frame: 0 Months

    Pain associated with osteoarthritis was mesured by Western Ontario and McMaster Universities Arthritis Index (WOMAC Index) - subscore pain. This instrument is widely used in the evaluation of Hip and Knee Osteoarthritis. It is a self-administered questionnaire consisting of 24 items divided into 3 subscales: Pain (5 items), Stiffness (2 items), and Physical Function (17 items). The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. Higher scores indicate worse pain, stiffness, and functional limitations.

  31. Physical Function associated with osteoarthritis

    Time frame: 0 Months

    Pain associated with osteoarthritis was mesured by Western Ontario and McMaster Universities Arthritis Index (WOMAC Index) - subscore pain. This instrument is widely used in the evaluation of Hip and Knee Osteoarthritis. It is a self-administered questionnaire consisting of 24 items divided into 3 subscales: Pain (5 items), Stiffness (2 items), and Physical Function (17 items). The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. Higher scores indicate worse pain, stiffness, and functional limitations.

  32. Functional Level of Lower Limbs

    Time frame: 0 Months

    To assess the functionality of the lower limbs, the Lower Extremity Functional Scale (LEFS) instrument was applied. The lower extremity functional scale is a valid patient-rated outcome measure for the measurement of lower extremity function. The score can vary between 0 and 80, with higher values representing better functionality.

  33. Handgrip strength (HGS)

    Time frame: 0 Months

    HGS was measured with the handgrip Dynamometer Lafayette Digital 5030D1 in both upper limbs.

  34. Identifies the concerns and priorities of older people

    Time frame: 0 Months

    Following the World Health Organisation, the "Integrated care for older people" (ICOPE) guidelines, each assessment with Age Care Technologies (ACT) Assessment generates a report which lists identifies concerns and priorities for action, together with several summary scores to measure needs, risks and outcomes, including: Quality of life, Falls risk, Vision, Hearing, Activities of Daily Living, Nutrition, Locomotor, Oral Health, Accommodation, Finances, Cognition, Depression, Loneliness, Social participation, and Violence against older people.

Sponsors and collaborators

Lead sponsor

Universidade do Algarve

Other

Collaborators

  • European Regional Development Fund

Registry information

Official study title

Effects of Sarcopenia on the Fall Risk, Body Composition, General Health Status and Quality of Life in Elderly: a Population-based Study

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Jun 26, 2023
Registry last updated
Aug 14, 2023

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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