Sarcopenia
Conditions
Keywords
Older Adults, Community-Dwelling Older Adults, Physical Activity, Nutrition Intervention, Quality of Life, Muscle Strength, Muscle Mass, Physical Performance, Randomized Controlled Trial
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.
Detailed description
The intervention component of this study is designed as a three-arm, parallel-group randomized controlled trial with a 1:1:1 allocation ratio. Eligible participants are randomly assigned to one of three parallel study arms: (1) a control group receiving health education; (2) a physical activity intervention group; or (3) a combined physical activity and nutritional support intervention group. Study outcomes are assessed repeatedly at three time points: before the intervention (T0), after 3 months (T1), and after 6 months (T2). The intervention period comprises two phases. Phase 1 covers weeks 1-12 and is intended to evaluate the effectiveness of the intervention. Phase 2 covers weeks 13-24 and is intended to evaluate the maintenance of intervention effects. The study evaluates changes in outcomes related to sarcopenia, including nutritional, body composition, muscle strength, physical performance, and quality-of-life outcomes, across the three study groups and over time. The trial was designed, conducted, and reported in accordance with the CONSORT 2010 recommendations for parallel-group randomized controlled trials. Ethical approval was obtained from the Institutional Review Board of Hanoi Medical University before enrollment of the first participant.
Interventions
BEHAVIORALHealth education
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.
BEHAVIORALPhysical Activity Intervention
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.
BEHAVIORALIndividualized Nutritional Counseling
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.
DIETARY_SUPPLEMENTOral nutritional supplementation
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.
Sponsors
University of Medicine and Pharmacy at Ho Chi Minh City
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Three-arm, parallel-group randomized controlled trial with a 1:1:1 allocation ratio.
Eligibility
Sex/Gender
ALL
Age
60 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Skeletal Muscle Mass Index (SMI) from baseline to 6 months | Baseline (T0), 3 months (T1), and 6 months (T2); primary comparison 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Handgrip Strength From Baseline to 6 Months | Baseline (T0), 3 months (T1), and 6 months (T2) | Handgrip strength (kg) is measured using a Camry EH101 handgrip dynamometer. Changes in handgrip strength are assessed across the three study groups over the study period. |
| Change in Gait Speed | Baseline, 3 months, and 6 months | Gait speed (m/s) is assessed using a standardized walking test. Changes in gait speed are evaluated from baseline (T0) to 3 months (T1) and 6 months (T2), with higher values indicating better physical performance |
| Change in Nutritional Status Assessed by the Mini Nutritional Assessment | Baseline (T0), 3 months (T1), and 6 months (T2) | Nutritional status is assessed using the Mini Nutritional Assessment (MNA). Changes in nutritional status are evaluated from baseline (T0) to 3 months (T1) and 6 months (T2) |
| Change in Dietary Energy, Protein Intake | Baseline (T0), 3 months (T1), and 6 months (T2) | Daily dietary energy, protein intake is assessed using the dietary assessment method specified in the study protocol. Changes in energy, protein intake are evaluated from baseline (T0) to 3 months (T1) and 6 months (T2). |
| Change in Quality of Life | Baseline (T0), 3 months (T1), and 6 months (T2) | Quality of life is assessed using the WHOQOL-OLD instrument. Changes in quality-of-life scores are evaluated from baseline (T0) to 3 months (T1) and 6 months (T2), with higher scores indicating better quality of life. |
Countries
Vietnam
Outcome results
None listed