Effectiveness of Nutrition and Exercise Interventions in Older Adults With Sarcopenia in Can Gio … (NCT07761091) | Clinical Trial Compass
CompletedNot Applicable
Effectiveness of Nutrition and Exercise Interventions in Older Adults With Sarcopenia in Can Gio District, Ho Chi Minh City
Vietnam90 participantsStarted 2024-01-10
Plain-language summary
Sarcopenia is an age-related condition characterized by progressive loss of muscle mass, muscle strength, and physical performance, which may adversely affect functional capacity and quality of life in older adults.
This study is a three-arm, parallel-group randomized controlled trial designed to evaluate the effects of physical activity and combined physical activity plus nutritional support among community-dwelling older adults with sarcopenia. Eligible participants are randomly allocated in a 1:1:1 ratio to one of three groups: (1) a control group receiving health education, (2) a physical activity intervention group, or (3) a combined physical activity and nutritional support intervention group.
Outcomes are assessed at baseline (T0), 3 months (T1), and 6 months (T2). The first 12 weeks evaluate the effects of the intervention, while weeks 13-24 evaluate the maintenance of intervention effects.
Who can participate
Age range
60 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Aged 60-70 years and residing in Can Gio District, Ho Chi Minh City, Vietnam.
* Listed in the local Older Persons Association registry.
* Diagnosed with sarcopenia according to the Asian Working Group for Sarcopenia (AWGS) 2019 criteria.
* Able to walk independently.
* Willing to participate in the study and provide written informed consent.
Exclusion Criteria:
* Recent or current participation in another clinical trial or dietary or physical activity intervention program.
* Current treatment for cancer or other malignancies.
* Chronic kidney disease requiring maintenance dialysis.
* Poorly controlled or unstable chronic obstructive pulmonary disease.
* Current musculoskeletal disease, recent injury, or recent surgery that limits physical activity.
* Current use of medications that may affect study outcomes, including weight-loss medications, corticosteroids, or thyroid hormones.
* Contraindication to the oral nutritional supplement (ONS) used in the study.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Skeletal Muscle Mass Index (SMI) from baseline to 6 months
Timeframe: Baseline (T0), 3 months (T1), and 6 months (T2); primary comparison from baseline to 6 months.
Trial details
NCT IDNCT07761091
SponsorUniversity of Medicine and Pharmacy at Ho Chi Minh City