Combined Exercise and Nutrition Intervention for Possible Sarcopenia Among Older Adults in Primary Care
- Conditions
- Sarcopenia
- Interventions
- Behavioral: Experimental group
- Registration Number
- NCT06049914
- Lead Sponsor
- Kyunghee University Medical Center
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 94
-
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)}]
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental group Experimental group 1. 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 2. 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
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 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.
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).
Grip strength Screening, 0st week of intervention, 6th week of intervention, 12th week of intervention Measure maximum grip strength with a grip dynamometer
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.
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.
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.
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.
Trial Locations
- Locations (3)
Seoulbom United Clinic
🇰🇷Dobong, Seoul, Korea, Republic of
Dongdong Family Medicine Clinic
🇰🇷Dobong, Seoul, Korea, Republic of
Dongbu-hanil Surgery Clinic
🇰🇷Dobong, Seoul, Korea, Republic of