Effects of Early Exercise in Patients With Moderate to Severe Stroke - a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 主要终点
- Change in Modified Rankin Scale (mRS)
研究概览
简要总结
Purpose: to investigate the efficacy of early exercise in patients with moderate to severe stroke regarding functional outcome and walking ability.
Methods: Patients with medium to severe stroke (NHISS >7) were recruited 24 - 48 hours after stroke onset from two stroke units in Sweden. Both groups received usual care. The intervention group received even 20 minutes bed-cycling 5 days per week with a maximum of 15 sessions. Functional outcome was measured with modified Rankin Scale (mRS) and Barthel index and walking with the 6-minute walking test (6MWT). Measurements were performed pre- and post-intervention (3 weeks), and at 3-months follow-up.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age over 18 years.
- •Diagnose stroke with The National Institutes of Health Stroke Scale (NIHSS) 7-42 points.
- •Ability to understand the Swedish language.
- •Approval of medical responsible physician to participate in the study.
排除标准
- •Medical or neurological diseases that can affect the performance of the exercise and severe cognitive impairment.
结局指标
主要结局
Change in Modified Rankin Scale (mRS)
时间窗: Baseline 24-48 hours after onset, postintervention 3 weeks after baseline and follow up 3-months after baseline.
Functional Outcome
次要结局
- Change in 6-Minutes Walking test (6MWT)(Baseline 24-48 hours after stroke onset, postintervention 3-weeks after baseline and follow up 3-months after baseline.)
- Change in Barthel ADL-Index(Baseline 24-48 hours after stroke onset, postintervention 3-weeks after baseline and follow up 3-months after baseline.)
研究者
Klas Sandberg
Clinical Investigator
Ostergotland County Council, Sweden