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.
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.
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.
- Conditions
- Sarcopenia, Sarcopenic Obesity, Frailty
- 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 group | Role | What they receive |
|---|---|---|
| Elderly | Group of 274 elderly Receives: Other: Sarcopenia Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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)
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
Body mass index (kg/m2) - body composition
Body mass index (kg/m2) was measured using the bioimpedance technique.
Measured: 0 Months
Fat Mass (kg and %) - body composition
Fat Mass (kg and %) was measured using the bioimpedance technique.
Measured: 0 Months
Fat-Free Mass (kg and %) - body composition
Fat-Free Mass (kg and %) was measured using the bioimpedance technique.
Measured: 0 Months
Fat Mass Index (kg/m2) - body composition
Fat Mass Index (kg/m2) was measured using the bioimpedance technique.
Measured: 0 Months
Fat-Free Mass Index (kg/m2) - body composition
Fat-Free Mass Index (kg/m2) was measured using the bioimpedance technique.
Measured: 0 Months
Muscle Mass Index (kg/m2) - body composition
Muscle Mass Index (kg/m2) was measured using the bioimpedance technique.
Measured: 0 Months
Total body water (L and %) - body composition
Total body water (L and %) was measured using the bioimpedance technique.
Measured: 0 Months
Resistence (Ohms) - body composition
Resistence (Ohms) was measured using the bioimpedance technique.
Measured: 0 Months
Reactance (Ohms) - body composition
Reactance (Ohms) was measured using the bioimpedance technique.
Measured: 0 Months
Phase angle (angle) - body composition
Phase angle was measured using the bioimpedance technique.
Measured: 0 Months
Visceral fat (L) - body composition
Visceral fat (L) was measured using the bioimpedance technique.
Measured: 0 Months
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
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
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
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
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
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
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
Postural Stability in elderly population
Postural stability was assessed by a force platform using the length displacement of center of pressure.
Measured: 0 Months
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
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
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
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
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
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
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
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
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
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
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
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
Handgrip strength (HGS)
HGS was measured with the handgrip Dynamometer Lafayette Digital 5030D1 in both upper limbs.
Measured: 0 Months
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.
- First posted26 Jun 2023
- Study start14 May 2019
- Primary completion20 Feb 2023
- Study completion20 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Universidade do Algarve
- Sponsor type
- University, hospital or other
- Collaborators
- European Regional Development Fund
- Responsible party
- Sponsor
- Investigators
- Sandra R Pais, PhD, Principal investigator, Universidade do Algarve
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
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Sarcopenia on the Fall Risk, Body Composition, General Health Status and Quality of Life in Elderly: a Population-based Study
- ClinicalTrials.gov ID
- NCT05918159
- Acronym / sponsor ID
- 0348_CIE_6_E_2
- Conditions
- Sarcopenia, Sarcopenic Obesity, Frailty
- Keywords
- Sarcopenia, Quality of Life, Frailty, Muscle Strength, Aging, Body Composition, Postural Balance, Falls
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 274 participants (actual)
- Lead sponsor
- Universidade do AlgarveUniversity, hospital or other
- Collaborators
- European Regional Development Fund
- Study start
- 14 May 2019 (actual)
- Primary completion
- 20 Feb 2023 (actual)
- Study completion
- 20 Feb 2023 (actual)
- First posted
- 26 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elderly | – | Other: Sarcopenia AssessmentGroup of 274 elderly |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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.
Key inclusion criteria (3 listed)
- Minimum age of 60 years;
- Live in the community;
- Independet Gait.
Key exclusion criteria (4 listed)
- Presence of moderate or severe cognitive impairment;
- Presence of uncontrolled cardiovascular disease and active cancer;
- Use of a pacemaker;
- Use of internal prosthesis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sarcopenia AssessmentThe prevalence of sarcopenia in a group of elderly people and its correlation with other health variables was determined. | Other | Elderly |
Primary outcome
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.
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.
34 secondary outcomes
Cognitive Assessment
Time frame: 0 Months
Body mass index (kg/m2) - body composition
Time frame: 0 Months
Fat Mass (kg and %) - body composition
Time frame: 0 Months
Fat-Free Mass (kg and %) - body composition
Time frame: 0 Months
Fat Mass Index (kg/m2) - body composition
Time frame: 0 Months
Fat-Free Mass Index (kg/m2) - body composition
Time frame: 0 Months
Muscle Mass Index (kg/m2) - body composition
Time frame: 0 Months
Total body water (L and %) - body composition
Time frame: 0 Months
Resistence (Ohms) - body composition
Time frame: 0 Months
Reactance (Ohms) - body composition
Time frame: 0 Months
Phase angle (angle) - body composition
Time frame: 0 Months
Visceral fat (L) - body composition
Time frame: 0 Months
High-density lipoprotein (HDL) cholesterol (mg/dL) - Lipid Profile
Time frame: 0 Months
Low-density lipoprotein (LDL) cholesterol (mg/dL) - Lipid Profile
Time frame: 0 Months
Triglycerides (mg/dL) - Lipid Profile
Time frame: 0 Months
Total cholesterol (mg/dL) - Lipid Profile
Time frame: 0 Months
Glicemic Profile in elderly
Time frame: 0 Months
Inflammatory levels in elderly population
Time frame: 0 Months
Nutritional level in elderly population
Time frame: 0 Months
Postural Stability in elderly population
Time frame: 0 Months
Peak Torque (N/m) of Quadriceps and Hamstring Muscles
Time frame: 0 Months
Work (N/m) of Quadriceps and Hamstring Muscles
Time frame: 0 Months
Power (N/m) of Quadriceps and Hamstring Muscles
Time frame: 0 Months
Peak torque time (s) of Quadriceps and Hamstring Muscles
Time frame: 0 Months
Force (kg) of Quadriceps and Hamstring Muscles
Time frame: 0 Months
Time up and Go (TUG) test - Fall risk in elderly population
Time frame: 0 Months
Modified Falls Efficacy Scale (MFES) - Fall risk in elderly population
Time frame: 0 Months
Physical Activity level in elderly population
Time frame: 0 Months
Pain associated with osteoarthritis
Time frame: 0 Months
Stiffness associated with osteoarthritis
Time frame: 0 Months
Physical Function associated with osteoarthritis
Time frame: 0 Months
Functional Level of Lower Limbs
Time frame: 0 Months
Handgrip strength (HGS)
Time frame: 0 Months
Identifies the concerns and priorities of older people
Time frame: 0 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandra R Pais, PhD principal investigator
Universidade do Algarve
1 site in 1 country: see every site and its status.
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.