Effectiveness of Nutrition and Physical Activity Interventions Among Older Adults With Sarcopenia in Can Gio District, Ho Chi Minh City, Vietnam
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Change in Skeletal Muscle Mass Index (SMI) from baseline to 6 months
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Physical Activity and Nutritional Support Intervention Group
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.
干预措施: Health education (Behavioral)
Control Group
Participants assigned to the control group receive health education according to the study protocol.
干预措施: Health education (Behavioral)
Physical Activity Intervention Group
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.
干预措施: Health education (Behavioral)
Physical Activity Intervention Group
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.
干预措施: Physical Activity Intervention (Behavioral)
Physical Activity and Nutritional Support Intervention Group
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.
干预措施: Physical Activity Intervention (Behavioral)
Physical Activity and Nutritional Support Intervention Group
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.
干预措施: Individualized Nutritional Counseling (Behavioral)
Physical Activity and Nutritional Support Intervention Group
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.
干预措施: Oral nutritional supplementation (Dietary Supplement)
结局指标
主要结局
Change in Skeletal Muscle Mass Index (SMI) from baseline to 6 months
时间窗: 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).
次要结局
- 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))
研究者
Tan Duy Doan
Principal Investigator
University of Medicine and Pharmacy at Ho Chi Minh City