Determining Optimal Post-Stroke Exercise (DOSE)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 12
- 主要终点
- Ambulatory function measured by the Six Minute Walk Test
研究概览
简要总结
The investigators will conduct a proof-of-concept study to provide preliminary evidence of efficacy of physical exercise dose on ambulatory function in adults undergoing sub-acute stroke rehabilitation.
详细描述
Participants admitted for stroke rehabilitation will be randomly assigned to either the Stroke Management Group, Stroke Monitoring Group or Stroke Supplementary Group. All three groups will receive usual care, in addition to the intervention. The Stroke Management Group will be provided with periodic information about their progress in the area of mobility using specialized activity monitors. The Stroke Monitoring Group will be progressed according to customized protocols using feedback from specialized activity monitors. The Stroke Supplementary Group will receive the same as the Stroke Monitoring Group, but will also receive one additional hour of daily (5 times per week) physical exercise
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 (Participant)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have been admitted to a hospital unit for stroke rehabilitation
- •Within 10 weeks post-stroke
- •19 years or older
- •Are experiencing difficulty walking
排除标准
- •Requires greater than one person assist for transfer or ambulation
- •Have uncontrolled medical condition or another serious medication condition in addition to stroke
- •Unable to understand or follow directions
结局指标
主要结局
Ambulatory function measured by the Six Minute Walk Test
时间窗: Rehabilitation discharge (average 4-5 weeks post admission)
次要结局
- Ambulatory Function from the Six Minute Walk Test(6 and 12 months post-stroke)
- Ambulatory function from the 5 Meter Walk Test(Rehabilitation discharge (average 4-5 weeks post admission) , 6 and 12 months post-stroke)
- Cognition measured by the Montreal Cognitive Assessment(Rehabilitation discharge (average 4-5 weeks post admission), 6 and 12 months post-stroke)
- Depression measured by Patient Health Questionnaire-9(Rehabilitation discharge (average 4-5 weeks post admission) , 6 and 12 months post-stroke)
- Cognition measured by the Digit Symbols Substitution Test(Rehabilitation discharge (average 4-5 weeks post admission) , 6 and 12 months post-stroke)
- Cognition measured by the Trail Making Test(Rehabilitation discharge (average 4-5 weeks post admission), 6 and 12 months post-stroke)
- Balance function from the Berg Balance Scale(Rehabilitation discharge (average 4-5 weeks post admission), 6 and 12 months post-stroke)
- Quality of life measured with EuroQol(Rehabilitation discharge (average 4-5 weeks post admission), 6 and 12 months post-stroke)
- Step count measured during the intervention sessions(From 10 intervention sessions within the 4-week intervention)
- Ambulatory function from the Functional Ambulation Classification(Rehabilitation discharge (average 4-5 weeks post admission), 6 and 12 months post-stroke)
- Heart rate measured during the intervention sessions(From 10 intervention sessions within the 4-week intervention)
研究者
Janice Eng
Principal Investigator
University of British Columbia