Effectiveness of Individual Physical Activity Programs to Prevent and Slow Progression of Sarcopenia and Frailty Among Thai Community-dwelling Older Adults: A Double-blind Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 360
- 试验地点
- 2
- 主要终点
- Muscle mass
研究概览
简要总结
Sarcopenia and frailty could be prevented and rehabilitated through individual physical activities in the form of combined exercise that could be practiced at home in daily life.
详细描述
The volunteers were randomly assigned to either the intervention or control group using sealed envelopes containing documents marked with either IG (intervention group) or CG (control group). The intervention group received training, after which they demonstrated and practiced the physical activities. They were provided with an exercise leaflet for self-practice at home and were followed up by phone, LINE application, and leaders of social club for older adults at least once a week to ensure regular practice. The older adults' relatives and caregivers were also trained and encouraged to practice with them in a 1:1 match. Support techniques and warning signs for stopping or taking a break during exercise were added to each posture, along with suggestions for suitable environmental management, such as flat plains, sufficient light, and no barriers within 2 meters, to reduce the risks of accidents. However, the control group did not receive any intervention apart from general suggestions and continued with their usual daily activities.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 60 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Individuals aged between 60 and 80 years.
- •Those who are able to walk independently or with the aid of walking devices.
排除标准
- •Participants with leg or foot amputations.
- •Participants who had been admitted to hospitals in the past 6 months.
- •Those with underlying medical conditions such as heart disease, bone and muscle injuries, and infectious diseases.
- •Individuals who did not pass the Physical Activity Readiness Questionnaire (PAR-Q).
结局指标
主要结局
Muscle mass
时间窗: 30 weeks
Appendicular skeletal muscle mass (ASM) was measured using the ACCUNIQ BC 380 tool based on bioelectrical impedance analysis (BIA), and the Skeletal Muscle Mass Index (SMI) was calculated by dividing ASM in kilograms by the height in meters squared. Low muscle mass is diagnosed if SMI is \< 7.0 kilograms/meter\^2 in men and \< 5.47 kg/m\^2 in women. Participants underwent assessments at both the beginning and the 30-week endpoint.
The status of sarcopenia aligns with the criteria set by the Asian Working Group for Sarcopenia (AWGS).
时间窗: 30 weeks
Sarcopenia status was assessed through three aspects, including a muscle strength test using handgrip strength measured with a dynamometer, a physical performance test using the Short Physical Performance Battery (SPPB), and an appendicular skeletal muscle mass (ASM) test measured with the ACCUNIQ BC 380 tool based on bioelectrical impedance analysis (BIA). The results were aligned with the standards set by the Asian Working Group for Sarcopenia (AWGS). Sarcopenia was diagnosed by low ASM with low muscle strength or low physical performance, dynapenia was diagnosed by low muscle strength only, and pre-sarcopenia was diagnosed by low ASM or low physical performance. Participants underwent assessments both at the beginning and at the 30-week endpoint.
Muscle strength
时间窗: 30 weeks
Muscle strength, specifically handgrip strength, was measured using a hand-held dynamometer. Participants gripped the dynamometer with their dominant hand while standing, maintaining their upper arm close to the body and their elbow bent to 90 degrees, exerting maximum force. This test was conducted twice, and the superior result was recorded. Low muscle strength was diagnosed if the handgrip strength was \< 26 kilograms in males and \< 18 kilograms in females. Participants underwent assessments at both the beginning and the 30-week endpoint.
Physical performance
时间窗: 30 weeks
The physical performance test utilized the Short Physical Performance Battery (SPPB) to evaluate physical function, with a maximum score of 12 points. Low physical performance was diagnosed if the SPPB score was ≤ 9. Participants underwent assessments at both the beginning and the 30-week endpoint.
次要结局
- Physical frailty status based on the 5 criteria of frailty phenotype, as defined by Fried et al. 2001.(30 weeks)
研究者
Visaratana Therakomen
Deputy Director for Academic Affairs of Bureau of Nutrition, Department of Health
Ministry of Health, Thailand