Study on the Safety and Effectiveness of a Rehabilitation Exercise Program for Individuals With Spinal Cord Injury in Community: A Randomized Controlled Trials
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 58
- 试验地点
- 2
- 主要终点
- 6 minute push test
研究概览
简要总结
Patients with spinal cord injury (SCI) who have reduced mobility have difficulty exercising on their own without proper guidance in the community. Community-based exercise programs are effective in removing various barriers such as lack of exercise programs, lack of experts, and lack of facilities. This study aims to verify the effectiveness and safety of a systematically designed customized exercise program for patients who live in the community and want to participate in exercise. Our study results will serve as a basis for creating an environment where more individuals with SCI can continue to exercise proactively and in the long term.
详细描述
People with SCI must perform regular exercise to improve function, quality of life, and reduce medical costs. However, SCI people with reduced mobility have difficulty exercising on their own without proper guidance in the community. Rehabilitation exercise for SCI people should be applied based on accurate functional assessment, and risk factors related to exercise should also be assessed. Community-based exercise programs are effective in removing various barriers such as lack of exercise programs, lack of experts, and lack of facilities.
This study aims to verify the effectiveness and safety of a systematically designed customized exercise program for SCI people who live in the community and want to participate in exercise. Based on the results of many previous studies, the investigators expect that program participants will have improved cardiopulmonary endurance and quality of life. Our study results will serve as a basis for creating an environment where more people with SCI can continue to exercise preemptively and in the long term.
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
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Spinal cord injury patients who are 19-65 years old or above and residing in the local community
- •Individuals who can not walk independently for more than 10 meters without assistance from others
- •Individuals whose elbow extensor strength is greater than muscle manual test (MMT) Fair
排除标准
- •Individuals who have difficulty understanding the exercise program or expressing their symptoms
- •Individuals who cannot participate in the intervention exercise program due to serious cardiovascular diseases
- •Individuals who are deemed unsuitable for this study by a specialist in rehabilitation medicine due to other medical conditions
结局指标
主要结局
6 minute push test
时间窗: Baseline evaluation and follow-up evaluation immediately after average 8-weeks of exercise program
Sub-maximal exercise test used to assess aerobic capacity and endurance. Longer distances indicate better athletic ability.
次要结局
- Spinal cord independence measure III(Baseline evaluation and follow-up evaluation immediately after average 8-weeks of exercise program)
- Modified functional reach test(Baseline evaluation and follow-up evaluation immediately after average 8-weeks of exercise program)
- Grip strength(Baseline evaluation and follow-up evaluation immediately after average 8-weeks of exercise program)
- Arm curl(Baseline evaluation and follow-up evaluation immediately after average 8-weeks of exercise program)
- Back scratch test(Baseline evaluation and follow-up evaluation immediately after average 8-weeks of exercise program)
- Beck anxiety inventory(Baseline evaluation and follow-up evaluation immediately after average 8-weeks of exercise program)
- Beck depression inventory(Baseline evaluation and follow-up evaluation immediately after average 8-weeks of exercise program)
- Fat-free mass from bioelectrical impedance analysis(Baseline evaluation and follow-up evaluation immediately after average 8-weeks of exercise program)
- Fat-free mass index from bioelectrical impedance analysis(Baseline evaluation and follow-up evaluation immediately after average 8-weeks of exercise program)
- Percent body fat from bioelectrical impedance analysis(Baseline evaluation and follow-up evaluation immediately after average 8-weeks of exercise program)
- skeletal muscle mass from bioelectrical impedance analysis(Baseline evaluation and follow-up evaluation immediately after average 8-weeks of exercise program)
- EuroQol 5 Dimension 5 Level(Baseline evaluation and follow-up evaluation immediately after average 8-weeks of exercise program)