Comparative Study of Multi-component Real-time Remote Rehabilitation and Self Rehabilitation in the Treatment of Sarcopenia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 104
- 主要终点
- Knee Extensor Strength
研究概览
简要总结
This study is designed as a single center, non blinded, randomized controlled, dual arm trial. We designed to allocate participants in a 1:1 ratio to compare the effects of real-time remote rehabilitation and self rehabilitation with multiple components on muscle strength, muscle mass, balance, and walking ability in patients with sarcopenia. Each participant signs an informed consent form before registering for the study. This protocol follows the 2013 Standard Protocol Project: Intervention Trial Recommendation Guidelines.
详细描述
This study is designed as a single center, non blinded, randomized controlled, dual arm trial. We designed to allocate participants in a 1:1 ratio to compare the effects of real-time remote rehabilitation and self rehabilitation with multiple components on muscle strength, muscle mass, balance, and walking ability in patients with sarcopenia. Each participant signs an informed consent form before registering for the study. This protocol follows the 2013 Standard Protocol Project: Intervention Trial Recommendation Guidelines.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •According to the diagnostic criteria for sarcopenia established by the Asian Working Group for Sarcopenia (AWGS):
- •Low muscle strength:
- •Handgrip strength < 28 kg for men, < 18 kg for women; and/or
- •Low physical performance:
- •Usual gait speed (6-Meter Gait Speed, 6MGS) ≤ 1.0 m/s; and/or
- •Low muscle mass:
- •Skeletal Muscle Mass Index (SMI) < 7.0 kg/m² for men, < 5.7 kg/m² for women.
排除标准
- •Unable or unwilling to undergo body composition measurement.
- •Regular exercise habits within the past 6 months (resistance training ≥ 2 times/week, moderate-intensity aerobic exercise ≥ 3 times/week).
- •History of unstable cardiovascular disease, stroke, diabetes, psychiatric disorders, or other contraindications to exercise in the past 6 months.
- •Previously diagnosed with rheumatoid arthritis.
- •History of conditions affecting motor coordination, such as poliomyelitis sequelae, epilepsy, or stroke sequelae.
- •Presence of implanted medical devices due to previous fractures, heart disease, or other conditions.
- •Diagnosis of malignant tumors.
- •Unable to independently use the WeChat mini program used in this study.
研究组 & 干预措施
Arm 1
In the "Fugu Medical" WeChat mini program, the intervention plan for the intervention group included: (1) dietary intake guidance and (2) exercise guidance. (1) Dietary intake guidance: The dietary guidance was mainly based on the general dietary guidelines for the elderly issued by the Chinese Nutrition Society. (2) Exercise guidance Exercise guidance included resistance training and balance training.
干预措施: dietary intake guidance and exercise guidance (Behavioral)
Arm 2
Participants in the control group only received rehabilitation program articles in the form of images and text through the mobile application. These materials also included dietary intake guidance and exercise instructions. The frequency and intensity of the exercise instructions were sent to the patients at the same time. However, their daily adherence, including whether the training was completed or whether the dietary intake was appropriate, was not checked, verified, or followed up.
干预措施: Control (Behavioral)
结局指标
主要结局
Knee Extensor Strength
时间窗: Week 12
Measurement of the maximal isometric strength of the knee extensor muscles using a dynamometer. Assessed at week 12.
次要结局
- Knee Extensor Strength(Week 6)
- Knee Flexor Strength(Weeks 6 and 12)
- Grip Strength (Upper Limb Muscle Strength)(Weeks 6 and 12)
- Timed Up and Go Test (TUGT)(Weeks 6 and 12)
- 6-Meter Gait Speed Test(Weeks 6 and 12)
- 6-Minute Walk Test (6MWT)(Weeks 6 and 12)
- Appendicular Skeletal Muscle Mass Index (ASMI)(Weeks 6 and 12)
- Knee Extensor Strength(Week 6)
- Knee Flexor Strength(Weeks 6 and 12)
- Grip Strength (Upper Limb Muscle Strength)(Weeks 6 and 12)
- Timed Up and Go Test (TUGT)(Weeks 6 and 12)
- 6-Meter Gait Speed Test(Weeks 6 and 12)
- 6-Minute Walk Test (6MWT)(Weeks 6 and 12)
- Appendicular Skeletal Muscle Mass Index (ASMI)(Weeks 6 and 12)
- Reversal of Sarcopenia(weeks 6 and 12)