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Completed

NCT Number: NCT07761091

Effectiveness of Nutrition and Exercise Interventions in Older Adults With Sarcopenia in Can Gio District, Ho Chi Minh City

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.

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Key information

Conditions

Sarcopenia Atrophy Behavior Motor Activity Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

60 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Can Gio

Ho Chi Minh City, Ho Chi Minh, 70000, Vietnam

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Health Education

Behavioral

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 intervention

Behavioral

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

Behavioral

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 supplementation

Dietary 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.

Primary outcomes

  1. 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).

Secondary outcomes

  1. Change in Handgrip Strength From Baseline to 6 Months

    Time frame: 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.

  2. Change in Gait Speed

    Time frame: 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

  3. Change in Nutritional Status Assessed by the Mini Nutritional Assessment

    Time frame: 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)

  4. Change in Dietary Energy, Protein Intake

    Time frame: 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).

  5. Change in Quality of Life

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Medicine and Pharmacy at Ho Chi Minh City

Other

Registry information

Official study title

Effectiveness of Nutrition and Physical Activity Interventions Among Older Adults With Sarcopenia in Can Gio District, Ho Chi Minh City, Vietnam

Acronym: HMUIRB1078

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 12, 2026
Registry last updated
Aug 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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