Combined exercise and nutrition program for older adults with possible sarcopenia
Combined Exercise and Nutrition Intervention for Possible Sarcopenia Among Community-dwelling Older Adults in Primary Care: A Randomized Controlled Trial
This study tests whether a 12-week program combining exercise and nutrition can help older adults with possible sarcopenia feel stronger and improve their quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 94 (estimated) |
| Ages | 65 Years to 85 Years |
| Sex | All |
| Sponsor | Kyunghee University Medical Center Academic / other |
| Locations | 3 sites (Dobong, Seoul and 2 other locations) |
| Trial ID | NCT06049914 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effects of a 12-week combined exercise and nutrition intervention on older adults aged 65 to 85 who show signs of possible sarcopenia. Participants will be divided into an experimental group receiving the intervention and a control group receiving standard care. The study aims to measure changes in sarcopenia indicators, physical function, and quality of life. Data will be collected to identify issues and areas for improvement in managing sarcopenia in primary care settings.
Who should consider this trial
Good fit: Ideal candidates are community-dwelling older adults aged 65 to 85 with possible sarcopenia as defined by specific criteria.
Not a fit: Patients with uncontrolled medical conditions such as renal failure, hypertension, or diabetes, or those receiving treatments affecting muscle mass may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve physical function and quality of life for older adults at risk of sarcopenia.
How similar studies have performed: Other studies have shown promising results with combined exercise and nutrition interventions for sarcopenia, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Dobong, Seoul and 2 other locations
- Dongdong Family Medicine Clinic — Dobong, Seoul, Korea, Republic of (Recruiting)
- Dongbu-hanil Surgery Clinic — Dobong, Seoul, Korea, Republic of (Recruiting)
- Seoulbom United Clinic — Dobong, Seoul, Korea, Republic of (Recruiting)
Study contacts
- Principal investigator: Chang Won Won, MD — Kyunghee University Medical Center
- Study coordinator: Minjin Kim
- Email: rhdeo64@naver.com
- Phone: rhdeo64@naver.com
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.