Effectiveness of Nutrition and Exercise Interventions in Older Adults With Sarcopenia in Can Gio District, Ho Chi Minh City
HMUIRB1078
2 other identifiers
interventional
90
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2024
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 10, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedFirst Submitted
Initial submission to the registry
August 7, 2026
CompletedFirst Posted
Study publicly available on registry
August 12, 2026
CompletedAugust 12, 2026
August 1, 2026
2 years
August 7, 2026
August 7, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Skeletal Muscle Mass Index (SMI) from baseline to 6 months
Skeletal muscle mass index (SMI, kg/m²) will be assessed using bioelectrical impedance analysis (InBody 770). The primary outcome is the change in SMI from baseline (T0) to 6 months (T2).
Baseline (T0), 3 months (T1), and 6 months (T2); primary comparison from baseline to 6 months.
Secondary Outcomes (5)
Change in Handgrip Strength From Baseline to 6 Months
Baseline (T0), 3 months (T1), and 6 months (T2)
Change in Gait Speed
Baseline, 3 months, and 6 months
Change in Nutritional Status Assessed by the Mini Nutritional Assessment
Baseline (T0), 3 months (T1), and 6 months (T2)
Change in Dietary Energy, Protein Intake
Baseline (T0), 3 months (T1), and 6 months (T2)
Change in Quality of Life
Baseline (T0), 3 months (T1), and 6 months (T2)
Study Arms (3)
Control Group
ACTIVE COMPARATORParticipants assigned to the control group receive health education according to the study protocol.
Physical Activity Intervention Group
EXPERIMENTALParticipants assigned to this group receive the physical activity intervention according to the study protocol during weeks 1-12, followed by the maintenance phase during weeks 13-24.
Physical Activity and Nutritional Support Intervention Group
EXPERIMENTALParticipants assigned to this group receive the physical activity intervention combined with nutritional support according to the study protocol during weeks 1-12, followed by the maintenance phase during weeks 13-24.
Interventions
A group-based health education session is provided at the beginning of the intervention by nutritionists from the University of Medicine and Pharmacy at Ho Chi Minh City. The education covers nutrition and physical activity for the prevention and management of sarcopenia and is delivered through a combination of face-to-face education and supporting materials, including a handbook and videos. This intervention is provided to participants in all three study arms.
A 24-week physical activity program specifically designed for older adults with sarcopenia and supervised by exercise specialists. The program consists of aerobic exercise for 30 minutes per session, twice weekly, and resistance exercise for 30 minutes per session, twice weekly. Exercise intensity is progressively increased according to each participant's capacity. The program combines supervised face-to-face sessions (once weekly during weeks 1-12 and once monthly during weeks 13-24) with supporting exercise guidance through a handbook and videos. The intervention is provided to the physical activity group and the combined physical activity plus nutritional support group.
Individualized nutritional counseling is provided by nutritionists from the University of Medicine and Pharmacy at Ho Chi Minh City through a combination of face-to-face and online counseling, once weekly during weeks 1-12. Counseling addresses energy requirements, protein intake, high-quality protein sources, dietary balance, and management of gastrointestinal symptoms.
Participants receive one bottle of oral nutritional supplement daily during weeks 1-12. Each bottle provides 270 kcal and 11 g of protein and contains HMB, omega-3, omega-6, omega-9 fatty acids, and vitamin D. Oral nutritional supplementation is discontinued during weeks 13-24 to evaluate maintenance of the intervention effects.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Can Gio
Ho Chi Minh City, Ho Chi Minh, 70000, Vietnam
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
August 7, 2026
First Posted
August 12, 2026
Study Start
January 10, 2024
Primary Completion
December 31, 2025
Study Completion
December 31, 2025
Last Updated
August 12, 2026
Record last verified: 2026-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Beginning 6 months after publication of the main study results and available for 5 years.
- Access Criteria
- Data will be available to qualified researchers who submit a methodologically sound proposal for scientific purposes. Requests will be reviewed by the principal investigator and relevant institution. Approved researchers will be required to comply with applicable ethical, confidentiality, and data-use requirements.
De-identified individual participant data that support the findings of the study may be made available to qualified researchers upon reasonable request to the principal investigator. Data sharing will be subject to scientific review, applicable ethical and institutional requirements, and execution of an appropriate data use agreement.