Stroke Recovery Program-Cardiac Rehabilitation of Stroke Survivors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- 6-Minute Walk Test (6MWT)
研究概览
简要总结
This study examines the effectiveness of the cardiac rehabilitation program for stroke patients. The study will examine if patients with stroke, who receive cardiac rehabilitation in addition to their standard of care treatments, demonstrate improved recovery of function. It will also examine if these patients have reduced hospital readmission, reduced rate of recurrent stroke, and mortality.
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
- •18 years or older
- •Stroke diagnosis (ischemic or hemorrhagic) / radiologic evidence of acute stroke
- •Medically cleared by a cardiologist for participation in the cardiac rehabilitation program with no contraindications to cardiac rehabilitation per American Association of Cardiovascular and Pulmonary Rehabilitation (AACVPR) guidelines
- •Ability to transfer on/off the recumbent bike with or without an assistive device safely, with or without assistance from another person
- •Ability to follow simple commands and communicate pain or distress
- •Admission to an Inpatient Rehabilitation Facility post-stroke
- •Signed informed consent form
排除标准
- •Presence of subarachnoid hemorrhage, intracranial aneurysm, intracranial hemangioma, or arteriovenous malformation
- •Medical disorders that preclude participation in the study as determined by the Principal Investigator.
- •Inability to have baseline assessment within 60 days post-stroke diagnosis
- •Patient considered unable to comply with study requirements
- •Known terminal illness with life expectancy less than 1 year
- •Compliant diagnosis eligible for traditional cardiac rehabilitation covered by insurance
- •Unable to understand/speak English
研究组 & 干预措施
Standard of care
Depending on functional deficits, conventional rehabilitation therapies can include physical therapy, occupational therapy, and/or speech therapy sessions with 2-3 visits per week. Participants will receive their standard of care therapies as prescribed by their treating physicians.
Cardiac rehabilitation group
Traditional medically supervised center-based cardiac rehabilitation program; including 36 sessions (30-50 minutes) of a progressive exercise program and educational sessions for cardiovascular disease (CVD) risk factors.
干预措施: Cardiac rehabilitation program (Other)
结局指标
主要结局
6-Minute Walk Test (6MWT)
时间窗: Change from Baseline (30 days post-stroke) to 120 days post-stroke.
Mean change in 6MWT score from baseline (30 days post-stroke) to 120 days post-stroke.
次要结局
- PHQ-9 - (Patient Health Questionnaire -9)(Change from Baseline (30 days post-stroke) to 120 days post-stroke)
- All-cause mortality rate(1-year post stroke)
- AM-PAC - (Activity Measure for Post Acute Care)(1-year post stroke)
- mRS - (Modified Rankin Scale)(Change from Baseline (30 days post stroke) to 120 days post stroke)
- MET-min - (Metabolic Equivalent of Task - minutes)(Change from Baseline (30 days post-stroke) to 120 days post-stroke.)
- SS-QOL - (Stroke specific Quality of Life)(1-year post stroke)
- All-cause hospital readmission(1-year post-stroke)
- 10-Minute Walk Test (10MWT)(Change from Baseline (30 days post-stroke) to 120 days post-stroke.)
- MoCA - (Montreal Cognitive Assessment)(Change from Baseline (30 days post-stroke) to 120 days post-stroke.)
- Recurrent stroke rate(1-year post stroke)
- Picture Your Plate (PYP)(Change from Baseline (30 days post stroke) to 120 days post stroke)
- AM-PAC - (Activity Measure for Post Acute Care)(Change from Baseline (30 days post-stroke) to 120 days post-stroke.)
- SS-QOL - (Stroke specific Quality of Life)(Change from Baseline (30 days post-stroke) to 120 days post-stroke)