- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05918159
Effects of Sarcopenia on General Health Status in Elderly: a Population-based Study
Effects of Sarcopenia on the Fall Risk, Body Composition, General Health Status and Quality of Life in Elderly: a Population-based Study
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Algarve
-
Faro, Algarve, Portugal, 8005-139
- Marta Botelho
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
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.
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Elderly
Group of 274 elderly
|
The prevalence of sarcopenia in a group of elderly people and its correlation with other health variables was determined.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
0 Months
|
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.
|
0 Months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
0 Months
|
Handgrip strength (HGS)
Time Frame: 0 Months
|
HGS was measured with the handgrip Dynamometer Lafayette Digital 5030D1 in both upper limbs.
|
0 Months
|
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.
|
0 Months
|
Body mass index (kg/m2) - body composition
Time Frame: 0 Months
|
Body mass index (kg/m2) was measured using the bioimpedance technique.
|
0 Months
|
Fat Mass (kg and %) - body composition
Time Frame: 0 Months
|
Fat Mass (kg and %) was measured using the bioimpedance technique.
|
0 Months
|
Fat-Free Mass (kg and %) - body composition
Time Frame: 0 Months
|
Fat-Free Mass (kg and %) was measured using the bioimpedance technique.
|
0 Months
|
Fat Mass Index (kg/m2) - body composition
Time Frame: 0 Months
|
Fat Mass Index (kg/m2) was measured using the bioimpedance technique.
|
0 Months
|
Fat-Free Mass Index (kg/m2) - body composition
Time Frame: 0 Months
|
Fat-Free Mass Index (kg/m2) was measured using the bioimpedance technique.
|
0 Months
|
Muscle Mass Index (kg/m2) - body composition
Time Frame: 0 Months
|
Muscle Mass Index (kg/m2) was measured using the bioimpedance technique.
|
0 Months
|
Total body water (L and %) - body composition
Time Frame: 0 Months
|
Total body water (L and %) was measured using the bioimpedance technique.
|
0 Months
|
Resistence (Ohms) - body composition
Time Frame: 0 Months
|
Resistence (Ohms) was measured using the bioimpedance technique.
|
0 Months
|
Reactance (Ohms) - body composition
Time Frame: 0 Months
|
Reactance (Ohms) was measured using the bioimpedance technique.
|
0 Months
|
Phase angle (angle) - body composition
Time Frame: 0 Months
|
Phase angle was measured using the bioimpedance technique.
|
0 Months
|
Visceral fat (L) - body composition
Time Frame: 0 Months
|
Visceral fat (L) was measured using the bioimpedance technique.
|
0 Months
|
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.
|
0 Months
|
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.
|
0 Months
|
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.
|
0 Months
|
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.
|
0 Months
|
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).
|
0 Months
|
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.
|
0 Months
|
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.
|
0 Months
|
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.
|
0 Months
|
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.
|
0 Months
|
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.
|
0 Months
|
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.
|
0 Months
|
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.
|
0 Months
|
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.
|
0 Months
|
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.
|
0 Months
|
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.
|
0 Months
|
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.
|
0 Months
|
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.
|
0 Months
|
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.
|
0 Months
|
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.
|
0 Months
|
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.
|
0 Months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Sandra R Pais, PhD, Universidade do Algarve
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0348_CIE_6_E_2
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Frailty
-
University of PennsylvaniaCompleted
-
Instituto Tecnologico y de Estudios Superiores...Not yet recruiting
-
Longeveron Inc.CompletedAging FrailtyUnited States
-
Longeveron Inc.CompletedAging FrailtyUnited States
-
The Hong Kong Polytechnic UniversityCompleted
-
Xijing HospitalUnknownFrailty SyndromeChina
-
Region ZealandUniversity of Southern DenmarkActive, not recruitingFrailty SyndromeDenmark
-
Neurological Associates of West Los AngelesEnrolling by invitation
-
IRCCS Centro San Giovanni di Dio FatebenefratelliCompleted
-
University of Erlangen-Nürnberg Medical SchoolCompleted
Clinical Trials on Sarcopenia Assessment
-
WepromRecruitingSarcopenia | Cancer of Head and Neck | CT ScanFrance
-
WepromCompletedMetastatic CancerFrance
-
Acibadem UniversityCompletedSarcopenia | Sjogren's Syndrome | Rheumatologic DiseaseTurkey
-
University Hospital, Clermont-FerrandUnknownSarcopenia | Chronic Heart FailureFrance
-
Universiti Tunku Abdul RahmanCompletedSarcopenia | Sarcopenic Obesity
-
University Hospital, Clermont-FerrandCompleted
-
CHU de ReimsUnknownPancreatic Cancer | Malnutrition | Sarcopenia | Liver CancerFrance
-
Far Eastern Memorial HospitalCompletedSarcopenia | COPD ExacerbationTaiwan
-
Brugmann University HospitalCompleted
-
Wirral University Teaching Hospital NHS TrustUnknownEmergencies | Frailty | SurgeryUnited Kingdom