AzTrials
AzTrials

SarcopeniaNCT05918159

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

An observational study of Sarcopenia and Sarcopenic Obesity, run by Universidade do Algarve at 1 site in Portugal.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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). Read more about this study

Who is it for?
Ages 60 years and olderHealthy volunteers can take part
Conditions the study is for
Sarcopenia, Sarcopenic Obesity, Frailty
What is being tested?
Sarcopenia Assessment
How many people
274 participants
Where
1 sitePortugal
Study dates
14 May 2019to 20 Feb 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: The participants of this study are people from the community of the Algarve region over 60 years old. To proceed with the recruitment of participants, the study was disseminated through promotional materials, such as flyers and posters in senior universities, institutions/associations, municipalities and parish councils, sports complexes, among other community spaces in the Algarve region. A non-probabilistic sampling was used. The sampling process consisted in a first phase of intentional sampling, which allowed recruiting many individuals over 60 years old who met the inclusion and exclusion criteria and in a second phase the sampling process was also carried out using the snowball method.

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Portugal1 site
  • Marta Botelho

    Faro, Algarve, 8005-139

Other trials in Portugal

About this study

Official title: Effects of Sarcopenia on the Fall Risk, Body Composition, General Health Status and Quality of Life 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.

Being tested
Sarcopenia Assessment
Keywords
Sarcopenia, Quality of Life, Frailty, Muscle Strength, Aging, Body Composition, Postural Balance, Falls
Medical subject headings
Sarcopenia, Frailty

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sarcopenia AssessmentOther

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

Study groups in NCT05918159
Study groupRoleWhat they receive
ElderlyGroup of 274 elderly
Receives: Other: Sarcopenia Assessment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Prevalence of Sarcopenia in elderly population

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

    Measured: 0 Months

  2. Quality of life in elderly population

    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.

    Measured: 0 Months

Secondary outcomes (34)
  1. Cognitive Assessment

    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.

    Measured: 0 Months

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

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

    Measured: 0 Months

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

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

    Measured: 0 Months

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

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

    Measured: 0 Months

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

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

    Measured: 0 Months

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

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

    Measured: 0 Months

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

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

    Measured: 0 Months

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

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

    Measured: 0 Months

  9. Resistence (Ohms) - body composition

    Resistence (Ohms) was measured using the bioimpedance technique.

    Measured: 0 Months

  10. Reactance (Ohms) - body composition

    Reactance (Ohms) was measured using the bioimpedance technique.

    Measured: 0 Months

  11. Phase angle (angle) - body composition

    Phase angle was measured using the bioimpedance technique.

    Measured: 0 Months

  12. Visceral fat (L) - body composition

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

    Measured: 0 Months

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

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

    Measured: 0 Months

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

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

    Measured: 0 Months

  15. Triglycerides (mg/dL) - Lipid Profile

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

    Measured: 0 Months

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

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

    Measured: 0 Months

  17. Glicemic Profile in elderly

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

    Measured: 0 Months

  18. Inflammatory levels in elderly population

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

    Measured: 0 Months

  19. Nutritional level in elderly population

    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.

    Measured: 0 Months

  20. Postural Stability in elderly population

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

    Measured: 0 Months

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

    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.

    Measured: 0 Months

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

    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.

    Measured: 0 Months

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

    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.

    Measured: 0 Months

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

    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.

    Measured: 0 Months

  25. Force (kg) of Quadriceps and Hamstring Muscles

    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.

    Measured: 0 Months

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

    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.

    Measured: 0 Months

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

    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.

    Measured: 0 Months

  28. Physical Activity level in elderly population

    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.

    Measured: 0 Months

  29. Pain associated with osteoarthritis

    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.

    Measured: 0 Months

  30. Stiffness associated with osteoarthritis

    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.

    Measured: 0 Months

  31. Physical Function associated with osteoarthritis

    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.

    Measured: 0 Months

  32. Functional Level of Lower Limbs

    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.

    Measured: 0 Months

  33. Handgrip strength (HGS)

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

    Measured: 0 Months

  34. Identifies the concerns and priorities of older people

    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.

    Measured: 0 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jun 2023
  2. Study start14 May 2019
  3. Primary completion20 Feb 2023
  4. Study completion20 Feb 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Cross-sectional
Enrolment
274 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05918159
Sponsor's protocol ID
0348_CIE_6_E_2
Status last verified
Aug 2023
First submitted
15 Jun 2023
Last updated
14 Aug 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Sarcopenia and Sarcopenic Obesity, run by Universidade do Algarve at 1 site in Portugal.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prevalence of Sarcopenia in elderly population (time frame: 0 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2023.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in