Sarcopenia
Conditions
Keywords
Sarcopenia, Elderly, Outpatient, Exercise, Intervention
Brief summary
The purpose of this study is to assess the impact of a combined exercise-nutrition intervention in primary clinics on sarcopenia indices, physical function, and quality of life in community-dwelling older adults with possible sarcopenia.
Detailed description
This study will investigate the effects of a 12-week combined exercise-nutrition intervention by comparing it with a control group receiving standard care (usual care) by assessing the sarcopenia indicators, functional recovery, and individual satisfaction. This is an interventional clinical study designed to recruit subjects, analyze data, identify problems, find improvement areas, and explore potential solutions.
Interventions
BEHAVIORALExperimental group
1. Exercise interventions * Measuring blood pressure and weight: before starting exercise * Flexibility exercises: 5-10 minutes of stretching * Strength exercises: Consists of 4 upper body exercises (Biceps Curl, Dips, Front raise, Chest press) and 5 lower body exercises (Leg lateral rotation, Leg extension, Hip abduction, Squat, Heel raise). The intensity of the band starts according to the subject's muscle strength. * Aerobic exercise: 5 times a week, home-based, 30 minutes or more each time 2. Nutritional interventions * Well nourished: Overall diet check and correction * at risk: Correction of diet and intake of up to 2 packs of supplemental protein products per day * Malnourished: Correction of diet and intake of up to 3 packs of supplemental protein products per day * Nutrition counseling is provided at the beginning of the intervention and high-protein diet composition education is provided * Confirm compliance and provide feedback once every 2 weeks
Sponsors
Kyunghee University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
DOUBLE (Subject, Investigator)
Intervention model description
12-week combined exercise-nutrition intervention
Eligibility
Sex/Gender
ALL
Age
65 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* 65 to 85 years of age * Men and women with possible sarcopenia * If included in the possible sarcopenia criteria in the 2019 Asian Working Group for Sarcopenia(AWGS) criteria A Simple Questionnaire to Rapidly Diagnose Sarcopenia(The Korean SARC-F questionnaire) score is 4 or higher; or Calf circumference (Men's: \<34 cm, Women's: \<33 cm) + Decreased muscle strength (male: \<28kg, female: \<18kg) or Decreased physical function (if it takes more than 12 seconds from the 5-chair stand test) * \[(1) and {(2) or (3)}\]
Exclusion criteria
* Renal failure: Serum creatine exceeding 2.0 mg/dl * Uncontrolled hypertension: systolic/diastolic blood pressure greater than 150/90 millimeter of mercury(mmHg) * Uncontrolled diabetes: glycated hemoglobin (HbA1C) over 7.5% * Subject who are receiving treatment (steroids, anticancer drugs, etc.) that can affect muscle mass * Subjects with myocardial infarction or angina pectoris, stroke disease * Malignant tumor: Subject who has a history of cancer within 5 years or is currently receiving treatment * Subjects who have liver cirrhosis and uncontrolled hepatitis (Aspartate aminotransferase or Alanine aminotransferase is more than three times the upper limit of the reference range) * Subjects who have chronic diseases such as musculoskeletal disorders that are impossible to exercise * Subjects who are allergic to soybeans, coix, and brown rice
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 5-time chair stand test | Screening, 0st week of intervention, 6th week of intervention, 12th week of intervention | a test of lower limb function that measures the fastest time taken to stand five times from a chair with arms folded. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Falls | 0st week of intervention, 12th week of intervention, 24th week of intervention | Falls Survey in Last 3 Months |
| EuroQol Visual Analogue Scale(EQ-VAS) | 0st week of intervention, 12th week of intervention | a vertical visual analogue scale that takes values between 100 (best imaginable health) and 0 (worst imaginable health), on which patients provide a global assessment of their health. |
| Korean version of Instrumental Activities of Daily Living (K-IADL) | 0st week of intervention, 6th week of intervention, 12th week of intervention, 24th week of intervention | Assess the skills and abilities needed to perform specific daily tasks related to an independent lifestyle in Korean version. |
| Korean version of Physical Activity Scale for the Elderly(K-PASE) | 0st week of intervention, 12th week of intervention | 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. |
| Grip strength | Screening, 0st week of intervention, 6th week of intervention, 12th week of intervention | Measure maximum grip strength with a grip dynamometer |
| Korean version of Mini-mental State Examination(K-MMSE) | 0st week of intervention, 12th week of intervention | a set of questions that commonly used to check for cognitive impairment (problems with thinking, communication, understanding and memory). |
| Korean version of Short Form of Geriatric Depression Scale(SGDS-K) | 0st week of intervention, 12th week of intervention, 24th week of intervention | Scores of 0-4 are considered normal, depending on age, education, and complaints; 5-8 indicate mild depression; 9-11 indicate moderate depression; and 12-15 indicate severe depression. |
| The 12-item Health Survey(SF-12) | 0st week of intervention, 12th week of intervention | Self-reported outcome measure assessing the impact of health on an individual's everyday life. It is used as a quality of life measure. |
| Mini Nutritional Assessment(MNA) | 0st week of intervention, 12th week of intervention | Mini Nutritional Assessment is a validated nutrition screening and assessment tool that can identify geriatric patients age 65 and above who are malnourished or at risk of malnutrition. |
Countries
South Korea
Contacts
Primary ContactMinjin Kim
Outcome results
None listed