An interventional study of Health education and Physical Activity Intervention in Sarcopenia, sponsored by University of Medicine and Pharmacy at Ho Chi Minh City. Completed at 1 site in Vietnam. Open to participants aged 60 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-08-12.
Sponsored by University of Medicine and Pharmacy at Ho Chi Minh City · Not applicable, Interventional, and Treatment
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.
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.
1,329 studies on the registry are indexed under Sarcopenia; 420 are open to participants now.
This study's enrollment of 90 is above the median of 60 across 855 interventional studies indexed under Sarcopenia.
Browse Sarcopenia studies →University of Medicine and Pharmacy at Ho Chi Minh City is the lead sponsor of 127 studies on the registry; 44 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants assigned to the control group receive health education according to the study protocol.
Behavioral: Health education
Participants 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.
Behavioral: Health education · Behavioral: Physical Activity Intervention
Participants 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.
Behavioral: Health education · Behavioral: Physical Activity Intervention · Behavioral: Individualized Nutritional Counseling · Dietary Supplement: Oral nutritional supplementation
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.
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).
Time frame: Baseline (T0), 3 months (T1), and 6 months (T2); primary comparison from baseline to 6 months.
Change in Handgrip Strength From Baseline to 6 Months
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.
Time frame: Baseline (T0), 3 months (T1), and 6 months (T2)
Change in Gait Speed
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
Time frame: Baseline, 3 months, and 6 months
Change in Nutritional Status Assessed by the Mini Nutritional Assessment
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)
Time frame: Baseline (T0), 3 months (T1), and 6 months (T2)
Change in Dietary Energy, Protein Intake
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).
Time frame: Baseline (T0), 3 months (T1), and 6 months (T2)
Change in Quality of Life
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.
Time frame: Baseline (T0), 3 months (T1), and 6 months (T2)
Plan to share: Yes — 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
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.
No publications or documents are linked to this record.
Ran from Jan 2024 to primary completion in Dec 2025, 23 months.
Of 492 non-industry interventional studies with no phase under Sarcopenia, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 34. This study's 23 months is above that.
Counting every sponsor, half of 503 studies reached it within 18 months; a quarter within 8 and three quarters within 34.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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