NCT05616858招募中不适用
Safety and Cardiopulmonary Efficacy of Complex Exercise Program for Stroke Patients in the Community
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Peak VO2
研究概览
简要总结
The physical and social effects of exercise programs and daily exercise have already been demonstrated in stroke. However, stroke survivors have shown a passive attitude towards the exercise program and there was little guideline and experience of the stroke exercise program in the community. Therefore, the study provides patients with an adequate guide to a complex exercise program after discharge based on the medical records.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Community indwelling stroke patients discharged from Pusan National University Yangsan Hospital
- •Independent ambulator (FAC over 4)
- •Independent daily activities (Modified Rankin Scale less than 2)
- •No apparent spasticity on hemiplegic side (Modified Ashworth scale less than 1)
- •Hemiplegic side motor grades (Manual muscle testing, MMT) more than 3
排除标准
- •MMSE less than 18
- •BBS less than 41
- •Severe aphagia who cannot communicate
- •Severe cardiovascular conditions inhibiting exercise programs
- •Musculoskeletal problems inhibiting exercise programs
- •Other medical conditions considered by physiatrists
研究组 & 干预措施
Control group
No Intervention
Group without exercise program
Intervention group
Experimental
Group with exercise program
干预措施: Complex exercise program (Behavioral)
结局指标
主要结局
Peak VO2
时间窗: Follow-up evaluation (through study completion, an average of 6 weeks)
Maximal VO2 from cardiopulmonary exercise test
Peak VO2
时间窗: Baseline evaluation
Maximal VO2 from cardiopulmonary exercise test
次要结局
- Fugl-Meyer assessment (0-226, the higher the better)(Follow-up evaluation (through study completion, an average of 6 weeks))
- Berg balance scale (0-56, the higher the better)(Follow-up evaluation (through study completion, an average of 6 weeks))
- Grip strength(Follow-up evaluation (through study completion, an average of 6 weeks))
- 6-minute walk test(Follow-up evaluation (through study completion, an average of 6 weeks))
- Functional ambulation category (0-5, the higher the better)(Follow-up evaluation (through study completion, an average of 6 weeks))
- Figure-of-eight walk test(Follow-up evaluation (through study completion, an average of 6 weeks))
- Manual function test (0-32, the higher the better)(Follow-up evaluation (through study completion, an average of 6 weeks))
- Korean Mini-Mental Status Examination (K-MMSE) (0-30, the higher the better)(Follow-up evaluation (through study completion, an average of 6 weeks))
- Timed up and go(Follow-up evaluation (through study completion, an average of 6 weeks))
- Chair sit-to-stand test(Follow-up evaluation (through study completion, an average of 6 weeks))
- Modified Barthel Index (Korean version) (0-100, the higher the better)(Follow-up evaluation (through study completion, an average of 6 weeks))
- Body composition analysis(Follow-up evaluation (through study completion, an average of 6 weeks))
- Sit-and-reach test(Follow-up evaluation (through study completion, an average of 6 weeks))
- Getriatic depression scale (0-15, the higher the more depressive)(Follow-up evaluation (through study completion, an average of 6 weeks))
- Euro-Quality of Life-5 Dimension (EQ-5D) (5-25, the higher the better)(Follow-up evaluation (through study completion, an average of 6 weeks))
- International Physical Activity Questionnaire (No scores)(Follow-up evaluation (through study completion, an average of 6 weeks))
- Functional ambulation category (0-5, the higher the better)(Baseline evaluation)
- Berg balance scale (0-56, the higher the better)(Baseline evaluation)
- Timed up and go(Baseline evaluation)
- Grip strength(Baseline evaluation)
- 6-minute walk test(Baseline evaluation)
- Figure-of-eight walk test(Baseline evaluation)
- Sit-and-reach test(Baseline evaluation)
- Chair sit-to-stand test(Baseline evaluation)
- Fugl-Meyer assessment (0-226, the higher the better)(Baseline evaluation)
- Manual function test (0-32, the higher the better)(Baseline evaluation)
- Modified Barthel Index (Korean version) (0-100, the higher the better)(Baseline evaluation)
- Body composition analysis(Baseline evaluation)
- Korean Mini-Mental Status Examination (K-MMSE) (0-30, the higher the better)(Baseline evaluation)
- Euro-Quality of Life-5 Dimension (EQ-5D) (5-25, the higher the better)(Baseline evaluation)
- Getriatic depression scale (0-15, the higher the more depressive)(Baseline evaluation)
- International Physical Activity Questionnaire (No scores)(Baseline evaluation)
研究者
Sung-Hwa Ko
Associate professor
Pusan National University Yangsan Hospital
研究点 (1)
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