Study on the Safety and Effectiveness of a Rehabilitation Exercise Program for Community-based Spinal Cord Injury Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 2
- 主要终点
- 6 minute walk distance
研究概览
简要总结
In the case of spinal cord injury, patients have shown a passive attitude towards participating in leisure sports or exercise programs, and there is a lack of suitable guidelines or experience in the local community for coaching exercise and sports for spinal cord injury patients, which makes coaches feel burdened when coaching these patients. Therefore, in this study, a suitable comprehensive exercise program will be designed and prescribed for patients who reside in the local community and want to participate in leisure sports, and the effectiveness and safety of the program will be verified. Based on the results, the aim of the study is to provide evidence that spinal cord injury patients can exercise safely and confidently in the local community in the future.
详细描述
Spinal cord injury is classified into complete paralysis and incomplete paralysis depending on the degree of spinal cord damage. In the case of complete paralysis, functional recovery is almost impossible, but in the case of incomplete paralysis, the level of functional recovery is determined through active rehabilitation exercises. In the past, most spinal cord injuries were traumatic, but due to the decrease in accidents, traumatic spinal cord injuries have decreased, and the incidence of non-traumatic spinal cord injuries (spinal cord disorders) has increased significantly due to aging. Most people with spinal cord injuries have difficulty performing appropriate rehabilitation exercises in the local community due to mobility impairments and limitations in daily activities. Spinal cord injury patients who participate in existing disabled sports are limited to some (relatively young) patients who have received epilepsy diagnosis. Individualized rehabilitation exercises based on each patient's personalized protocol are necessary, and sufficient functional recovery can be achieved through this approach. It is predicted that rehabilitation exercises through a protocol will improve cardiac and respiratory function and quality of life. Rehabilitation exercises for spinal cord injury patients should be applied based on accurate evaluation of function, and assessment of exercise-related risk factors should also be conducted. Customized exercise programs based on individual exercise function evaluations should be applied, but currently there is a lack of rehabilitation exercise programs that consider this. Additionally, risk factor evaluations related to exercise are not being conducted. Therefore, the development and application of patient-tailored community-based rehabilitation exercise programs for spinal cord injury patients that include risk factor evaluations and functional assessments are necessary.
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 —（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 years old or above and residing in the local community
- •A person who can walk independently for more than 10 meters without assistance from others
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 walk distance
时间窗: Baseline evaluation and follow-up evaluation immediately after average 2 months of exercise program
Sub-maximal exercise test used to assess aerobic capacity and endurance. Longer distances indicate better athletic ability.
EuroQol 5 Dimension 5 Level
时间窗: Baseline evaluation and follow-up evaluation immediately after average 2 months of exercise program
Self-report survey that measures quality of life across 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Converting the patient's response results using quality weights has a value between 0.000 and 1.000. A higher score means a higher quality of life.
次要结局
- Grip strength(Baseline evaluation and follow-up evaluation immediately after average 2 months of exercise program)
- 30 second sit to stand test(Baseline evaluation and follow-up evaluation immediately after average 2 months of exercise program)
- Beck anxiety inventory(Baseline evaluation and follow-up evaluation immediately after average 2 months of exercise program)
- Fat-free mass from bioelectrical impedance analysis(Baseline evaluation and follow-up evaluation immediately after average 2 months of exercise program)
- Fat-free mass index from bioelectrical impedance analysis(Baseline evaluation and follow-up evaluation after average 2 months of exercise program)
- Timed up and go test(Baseline evaluation and follow-up evaluation immediately after average 2 months of exercise program)
- Spinal cord independence measure III(Baseline evaluation and follow-up evaluation immediately after average 2 months of exercise program)
- Percent body fat from bioelectrical impedance analysis(Baseline evaluation and follow-up evaluation immediately after average 2 months of exercise program)
- Berg balance scale(Baseline evaluation and follow-up evaluation after average 2 months of exercise program)
- Sit and reach test(Baseline evaluation and follow-up evaluation immediately after average 2 months of exercise program)
- Beck depression inventory(Baseline evaluation and follow-up evaluation immediately after average 2 months of exercise program)
- skeletal muscle mass from bioelectrical impedance analysis(Baseline evaluation and follow-up evaluation immediately after average 2 months of exercise program)
研究者
Sungchul Huh
Assistant professor
Pusan National University Yangsan Hospital