Suspended

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

What is being tested

Experimental group

Behavioral

Who is being recruted

Atrophy+8

+ Behavior

+ Motor Activity

From 65 to 85 Years

See all eligibility criteria

How is the trial designed

Screening Study

Interventional

Study Start: August 2023

See protocol details

Summary

Principal SponsorKyunghee University Medical Center

Study ContactMinjin Kim

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: August 8, 2023

Actual date on which the first participant was enrolled.

This study focuses on helping older adults who live in the community and may be at risk of a condition called sarcopenia, which involves the loss of muscle mass and strength. Researchers aim to see if a 12-week program that combines exercise and nutrition can improve muscle health and overall well-being compared to those who receive the usual care. This is important because improving muscle health can help older adults maintain their independence and quality of life. Participants in the study will be divided into two groups. One group will follow a specific exercise and nutrition program, while the other group will continue with their usual care. Throughout the 12-week period, researchers will assess changes in muscle health, recovery of physical function, and how satisfied participants are with the program. The study does not mention any specific risks, but the potential benefit is that participants could see improvements in their muscle strength and overall health.

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

NCT06049914

Principal SponsorKyunghee University Medical Center

Study ContactMinjin Kim

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

94 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Screening Study

Screening studies test new methods to find diseases or risk factors early—before any symptoms appear. This helps catch health issues sooner, when they may be easier to treat.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 65 to 85 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

AtrophyBehaviorMotor ActivityMuscular AtrophyNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPathological Conditions, AnatomicalNeuromuscular ManifestationsSarcopenia

Criteria

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 3 locations

Recruiting

Dongdong Family Medicine Clinic

Dobong, South KoreaOpen Dongdong Family Medicine Clinic in Google Maps

Recruiting

Dongbu-hanil Surgery Clinic

Dobong, South Korea

Recruiting

Seoulbom United Clinic

Dobong, South Korea

Suspended3 Study Centers