Comprehensive Cardiac Rehabilitation Programming For Patients Following Transient Ischemic Attack
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 132
- 试验地点
- 4
- 主要终点
- To determine compared to usual care, whether a 6-month CR strategy results in significant improvements of functional capacity, lipid profile, depression symptoms and cognition.
研究概览
简要总结
The purpose of this study is to determine, in patients following a TIA, whether a 6-month case-managed exercise based multi-factorial cardiac rehabilitation program (CR), similar to those used in patients following a heart attack, can significantly improve exercise capacity, reduce cholesterol, reduce depression, and improve thinking ability.
详细描述
Similar risk factors predispose patients to both cardiovascular and cerebrovascular events. Two hundred consecutive patients from Stroke Prevention Clinics (SPC) at London Health Sciences Centre and the Ottawa Hospital (100 patients from each site) who have sustained a Transient Ischemic Attack (TIA) or mild non-disabling stroke will participate in a randomized controlled trial in which they will either receive Usual Care (UC) as delivered by the SPC, or enter the existing multi-disciplinary 6-month comprehensive cardiac rehabilitation (CR) intervention at LHSC and Ottawa in addition to receiving UC. This study seeks to determine the benefits of providing a CR program to TIA/mild non-disabling stroke patients.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented TIA or mild non-disabling stroke within the previous 3 months.
- •At least one of the following vascular risk factors: hypertension, ischemic heart disease, diabetes mellitus, dyslipidemia or cigarette smoking
排除标准
- •Inability to speak or understand English or provide informed consent.
- •Severe aphasia that renders communication difficult or impossible.
- •Modified Rankin Scale score of greater than or equal to
- •Mini-Mental Status Examination score of less than or equal to
- •Evidence of intracranial hemorrhage confirmed by CT scan or MRI study.
- •Anticipated or recent (<30 days) carotid endarterectomy, angioplasty and/or stenting.
- •Resides >1 hour travel time from London or Ottawa.
- •Prior participation in a CCR program.
- •Inability to perform expected exercise training of CCR program.
- •Evidence of cardioembolic source for TIA/stroke such as atrial fibrillation, valvular disease, septal defect or left ventricular wall motion abnormality.
- •Participation in another clinical trial that could interfere with the intervention or outcomes of the current study.
研究组 & 干预措施
Usual Care
Usual Care as provided through the Stroke Prevention Clinic
Cardiac Rehabilitation
Usual Care plus Comprehensive Cardiac Rehabilitation Program
干预措施: Comprehensive Cardiac Rehabilitation (CR) (Behavioral)
结局指标
主要结局
To determine compared to usual care, whether a 6-month CR strategy results in significant improvements of functional capacity, lipid profile, depression symptoms and cognition.
时间窗: 6 months
次要结局
- Outcomes include cerebrovascular and cardiovascular events, pre-post changes in physiological, anthropometric and behavioral vascular risk factors, neurocognitive measures, and quality of life.(6 months)