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

Sarcopenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05918159
• Other study ID #: 0348_CIE_6_E_2
• Status: Completed
• Start date: May 14, 2019
• Est. completion date: February 20, 2023

Study information

• Verified date: August 2023
• Source: Universidade do Algarve
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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). 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 274
• Est. completion date: February 20, 2023
• Est. primary completion date: February 20, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Frailty
• Sarcopenia
• Sarcopenic Obesity

Intervention

Other:
• Sarcopenia Assessment
The prevalence of sarcopenia in a group of elderly people and its correlation with other health variables was determined.

Locations

Country	Name	City	State
Portugal	Marta Botelho	Faro	Algarve

Sponsors (2)

Lead Sponsor	Collaborator
Universidade do Algarve	European Regional Development Fund

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	0 Months
Primary	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.	0 Months
Secondary	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.	0 Months
Secondary	Body mass index (kg/m2) - body composition	Body mass index (kg/m2) was measured using the bioimpedance technique.	0 Months
Secondary	Fat Mass (kg and %) - body composition	Fat Mass (kg and %) was measured using the bioimpedance technique.	0 Months
Secondary	Fat-Free Mass (kg and %) - body composition	Fat-Free Mass (kg and %) was measured using the bioimpedance technique.	0 Months
Secondary	Fat Mass Index (kg/m2) - body composition	Fat Mass Index (kg/m2) was measured using the bioimpedance technique.	0 Months
Secondary	Fat-Free Mass Index (kg/m2) - body composition	Fat-Free Mass Index (kg/m2) was measured using the bioimpedance technique.	0 Months
Secondary	Muscle Mass Index (kg/m2) - body composition	Muscle Mass Index (kg/m2) was measured using the bioimpedance technique.	0 Months
Secondary	Total body water (L and %) - body composition	Total body water (L and %) was measured using the bioimpedance technique.	0 Months
Secondary	Resistence (Ohms) - body composition	Resistence (Ohms) was measured using the bioimpedance technique.	0 Months
Secondary	Reactance (Ohms) - body composition	Reactance (Ohms) was measured using the bioimpedance technique.	0 Months
Secondary	Phase angle (angle) - body composition	Phase angle was measured using the bioimpedance technique.	0 Months
Secondary	Visceral fat (L) - body composition	Visceral fat (L) was measured using the bioimpedance technique.	0 Months
Secondary	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.	0 Months
Secondary	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.	0 Months
Secondary	Triglycerides (mg/dL) - Lipid Profile	Triglycerides (mg/dL) was measured taking a sample blood which was analysed by the COBAS b 101 system.	0 Months
Secondary	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.	0 Months
Secondary	Glicemic Profile in elderly	Glicemic Profile was measured by COBAS b 101 system, taking a sample blood which was analysed for Glycated Hemoglobin (HbA1c).	0 Months
Secondary	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.	0 Months
Secondary	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.	0 Months
Secondary	Postural Stability in elderly population	Postural stability was assessed by a force platform using the length displacement of center of pressure.	0 Months
Secondary	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.	0 Months
Secondary	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.	0 Months
Secondary	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.	0 Months
Secondary	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.	0 Months
Secondary	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.	0 Months
Secondary	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.	0 Months
Secondary	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.	0 Months
Secondary	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.	0 Months
Secondary	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.	0 Months
Secondary	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.	0 Months
Secondary	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.	0 Months
Secondary	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.	0 Months
Secondary	Handgrip strength (HGS)	HGS was measured with the handgrip Dynamometer Lafayette Digital 5030D1 in both upper limbs.	0 Months
Secondary	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.	0 Months