SarcopeniaHMUIRB1078NCT07761091
Effectiveness of Nutrition and Exercise Interventions in Older Adults With Sarcopenia in Can Gio District, Ho Chi Minh City
A study testing Health education, Physical Activity Intervention and Individualized Nutritional Counseling in people with Sarcopenia, run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 70 years
- Conditions the study is for
- Sarcopenia
- What is being tested?
- Health education, Physical Activity Intervention and Individualized Nutritional Counseling
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteVietnam
- Study dates
- 10 Jan 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Nutrition and Physical Activity Interventions Among Older Adults With Sarcopenia in Can Gio District, Ho Chi Minh City, Vietnam
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.
Read the 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.
- Conditions
- Sarcopenia
- Being tested
- Health education, Physical Activity Intervention, Individualized Nutritional Counseling, Oral nutritional supplementation
- Keywords
- Older Adults, Community-Dwelling Older Adults, Physical Activity, Nutrition Intervention, Quality of Life, Muscle Strength, Muscle Mass, Physical Performance, Randomized Controlled Trial
- Medical subject headings
- Sarcopenia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health educationBehavioural
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.
Physical Activity InterventionBehavioural
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 CounselingBehavioural
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.
Oral nutritional supplementationDietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Participants assigned to the control group receive health education according to the study protocol. Receives: Behavioral: Health education |
| Physical Activity Intervention Group | Experimental | 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. Receives: Behavioral: Health education; Behavioral: Physical Activity Intervention |
| Physical Activity and Nutritional Support Intervention Group | Experimental | 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. Receives: Behavioral: Health education; Behavioral: Physical Activity Intervention; Behavioral: Individualized Nutritional Counseling; Dietary Supplement: Oral nutritional supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
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.
Measured: 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
Measured: 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)
Measured: 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).
Measured: 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.
Measured: Baseline (T0), 3 months (T1), and 6 months (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2026
- Study start10 Jan 2024
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- More trials run by University of Medicine and Pharmacy at Ho Chi Minh CityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Three-arm, parallel-group randomized controlled trial with a 1:1:1 allocation ratio.
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tan Duy Doan, University of Medicine and Pharmacy at Ho Chi Minh City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07761091
- Sponsor's protocol ID
- HMU-01230004-HMUIRB1078
- Other IDs
- HMUIRB1078
- Acronym
- HMUIRB1078
- Status last verified
- Aug 2026
- First submitted
- 7 Aug 2026
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Doan TD, Le HTT, Pham TN, Truong AT, Le HT. Effectiveness of Nutrition and Exercise Interventions Among Community-Dwelling Older Vietnamese Adults with Sarcopenia: A Cluster-Randomized Controlled Trial. Nutrients. 2026 Sep 20;18(18):3080. doi: 10.3390/nu18183080.
PubMed 42797063
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Nutrition and Physical Activity Interventions Among Older Adults With Sarcopenia in Can Gio District, Ho Chi Minh City, Vietnam
- ClinicalTrials.gov ID
- NCT07761091
- Acronym / sponsor ID
- HMUIRB1078 / HMU-01230004-HMUIRB1078
- Conditions
- Sarcopenia
- Keywords
- Older Adults, Community-Dwelling Older Adults, Physical Activity, Nutrition Intervention, Quality of Life, Muscle Strength, Muscle Mass, Physical Performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of Medicine and Pharmacy at Ho Chi Minh CityUniversity, hospital or other
- Study start
- 10 Jan 2024 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 12 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Three-arm, parallel-group randomized controlled trial with a 1:1:1 allocation ratio.
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Behavioral: Health educationParticipants assigned to the control group receive health education according to the study protocol. |
| Physical Activity Intervention Group | Experimental | Behavioral: Health education, Behavioral: Physical Activity InterventionParticipants 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 | Experimental | Behavioral: Health education, Behavioral: Physical Activity Intervention, Behavioral: Individualized Nutritional Counseling, Dietary Supplement: Oral nutritional supplementationParticipants 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. |
Who may qualify
- Ages
- 60 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health educationA 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. | Behavioural | Control Group, Physical Activity Intervention Group, Physical Activity and Nutritional Support Intervention Group |
| Physical Activity InterventionA 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. | Behavioural | Physical Activity Intervention Group, Physical Activity and Nutritional Support Intervention Group |
| Individualized Nutritional CounselingIndividualized 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. | Behavioural | Physical Activity and Nutritional Support Intervention Group |
| Oral nutritional supplementationParticipants 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. | Dietary supplement | Physical Activity and Nutritional Support Intervention Group |
Primary outcome
Change in Skeletal Muscle Mass Index (SMI) from baseline to 6 months
Time frame: 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).
5 secondary outcomes
Change in Handgrip Strength From Baseline to 6 Months
Time frame: Baseline (T0), 3 months (T1), and 6 months (T2)
Change in Gait Speed
Time frame: Baseline, 3 months, and 6 months
Change in Nutritional Status Assessed by the Mini Nutritional Assessment
Time frame: Baseline (T0), 3 months (T1), and 6 months (T2)
Change in Dietary Energy, Protein Intake
Time frame: Baseline (T0), 3 months (T1), and 6 months (T2)
Change in Quality of Life
Time frame: Baseline (T0), 3 months (T1), and 6 months (T2)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Derived from this study: PubMed 42797063Doan TD, Le HTT, Pham TN, Truong AT, Le HT. Effectiveness of Nutrition and Exercise Interventions Among Community-Dwelling Older Vietnamese Adults with Sarcopenia: A Cluster-Randomized Controlled Trial. Nutrients. 2026 Sep 20;18(18):3080. doi: 10.3390/nu18183080.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health education, Physical Activity Intervention and Individualized Nutritional Counseling in people with Sarcopenia, run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Skeletal Muscle Mass Index (SMI) from baseline to 6 months (time frame: Baseline (T0), 3 months (T1), and 6 months (T2); primary comparison from baseline to 6 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07761091, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.