Combined Exercise and Nutrition Intervention for Possible Sarcopenia Among Older Adults in Primary Care

Study Overview
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Brief Summary
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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
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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.

Official Title
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Combined Exercise and Nutrition Intervention for Possible Sarcopenia Among Community-dwelling Older Adults in Primary Care: A Randomized Controlled Trial

Conditions
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Sarcopenia

Intervention / Treatment
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* Behavioral: Experimental group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 12-week combined exercise-nutrition intervention
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>Exercise interventions Visiting the primary clinic twice a week and exercising at home once a week for a total of 6 weeks during the introductory and expanding period, and then visiting the primary clinic once a week and exercising at home twice a week for 6 weeks during the maintenance period For exercise intervention, the researcher visits the primary clinic and conducts it face-to-face Flexibility and strength Exercises: Up to 4 group exercises under the guidance of researchers, up to 40 minutes scheduled Nutritional interventions Evaluate nutritional status through Mini Nutritional Assessment(MNA) survey at the time of Visit 1 Supplementary protein products are provided only for the malnourished group and at risk group with a MNA score of 23.5 or lower Supplementary protein products: 'Mediwell', healthy five-grain flavor, liquid 150 ml, 150 kcal, 20g carbohydrates, 2g sugars, 8g protein, 5g fat | Behavioral: Experimental group<br>* 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 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<br>|
| No Intervention: Control group<br>Control group: Providing only video and educational materials without intervention (12 weeks) Videos and educational materials are provided to both the experimental group and the control group for home exercise. Subjects write flexibility exercises, strength exercises, aerobic exercises, and meal diaries at home. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 5-time chair stand test | a test of lower limb function that measures the fastest time taken to stand five times from a chair with arms folded. | Screening, 0st week of intervention, 6th week of intervention, 12th week of intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Grip strength | Measure maximum grip strength with a grip dynamometer | Screening, 0st week of intervention, 6th week of intervention, 12th week of intervention | 
| Falls | Falls Survey in Last 3 Months | 0st week of intervention, 12th week of intervention, 24th week of intervention | 
| EuroQol Visual Analogue Scale(EQ-VAS) | 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. | 0st week of intervention, 12th week of intervention | 
| Korean version of Instrumental Activities of Daily Living (K-IADL) | Assess the skills and abilities needed to perform specific daily tasks related to an independent lifestyle in Korean version. | 0st week of intervention, 6th week of intervention, 12th week of intervention, 24th week of intervention | 
| Korean version of Physical Activity Scale for the Elderly(K-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. | 0st week of intervention, 12th week of intervention | 
| Mini Nutritional Assessment(MNA) | 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. | 0st week of intervention, 12th week of intervention | 
| Korean version of Mini-mental State Examination(K-MMSE) | a set of questions that commonly used to check for cognitive impairment (problems with thinking, communication, understanding and memory). | 0st week of intervention, 12th week of intervention | 
| Korean version of Short Form of Geriatric Depression Scale(SGDS-K) | 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. | 0st week of intervention, 12th week of intervention, 24th week of intervention | 
| The 12-item Health Survey(SF-12) | Self-reported outcome measure assessing the impact of health on an individual's everyday life. It is used as a quality of life measure. | 0st week of intervention, 12th week of intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sarcopenia, Elderly, Outpatient, Exercise, Intervention