Effectiveness of a Program of Rehabilitative Exercise and Education to Avert Vascular Events After Non-disabling Stroke: A Multi-site RCT
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 187
- 试验地点
- 4
- 主要终点
- diastolic blood pressure
研究概览
简要总结
The objective of the Program of Rehabilitative Exercise and Education to avert Vascular Events after Non-disabling stroke and Transient ischemic attack (PREVENT) Trial is to determine whether the timely delivery of secondary stroke prevention strategies will reduce modifiable vascular risk factors in two groups of people who have survived NDS or TIA. One group will receive a comprehensive education and exercise program (PREVENT); the other group will receive usual care (USUAL CARE). We will measure modifiable vascular risk factors in both groups. We will also compare the effects of PREVENT vs USUAL CARE on exercise capacity, walking endurance, and daily physical activity. In addition, we will compare thinking ability, depression, achievement of personal goals for healthy behavior, and health-related goal attainment and health-related quality of life. Finally, we will compare outcomes in urban and rural settings as well as costs of the PREVENT program and USUAL CARE in order to assess sustainability of the PREVENT program.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 17 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females
- •Over 17 years of age.
- •Diagnosis of first probable or definite TIA or non-disabling stroke (National Institutes of Health Stroke Scale < 6)
- •Post-event interval of <90 days.
- •Residence within 75 km of intervention site.
- •Orientation to time, place and person and ability to follow simple 3-step commands.
- •Ability and willingness to provide informed consent.
排除标准
- •Evidence of intracranial hemorrhage on MRI or CT scan.
- •Presence of contraindications to exercise testing and training, in accordance with American College of Sports Medicine Guidelines.
- •Participation in another study that could potentially confound the outcomes of this trial.
研究组 & 干预措施
PREVENT program
12-week program of exercise and education to induce physiological and behavioral changes needed to reduce vascular risk factors.
干预措施: PREVENT program (Behavioral)
Usual Care
Average of three visits to the Neurovascular Clinic for a neurological and health assessment, counseling regarding stroke/TIA and diagnostic test results, and assessment, modification and education of secondary prevention factors
干预措施: Usual Care (Behavioral)
结局指标
主要结局
diastolic blood pressure
时间窗: baseline, post-intervention, 6 months, 12 months
systolic blood pressure (primary vascular risk factor being assessed)
时间窗: baseline, post-intervention, 6 months, 12 months
waist circumference
时间窗: baseline, post-intervention, 6 months, 12 months
12-hour fasting glucose/hemoglobin A1C
时间窗: baseline, post-intervention, 6 months, 12 months
12-hour fasting lipid profile
时间窗: baseline, post-intervention, 6 months, 12 months
次要结局
- walking endurance(baseline, post-intervention, 6 months, 12 months)
- cigarette smoking(baseline, post-intervention, 6 months, 12 months)
- exercise capacity(baseline, post-intervention, 12 months)
- daily physical activity(baseline, post-intervention, 6 months, 12 months)
- cognition(baseline, 12 months)
- depression(baseline, post-intervention, 6 months, 12 months)
- health-related quality of life(baseline, post-intervention, 6 months, 12 months)
- health-related goal attainment(baseline, post-intervention, 6 months, 12 months)
- direct health costs(baseline, post-intervention, 6 months, 12 months)
- secondary vascular events(baseline, post-intervention, 6 months, 12 months)
- medication adherence(baseline, post-intervention, 6 months, 12 months)
- daily step count(baseline, post-intervention, 12 months)
研究者
Marilyn MacKay-Lyons
Affiliated Scientist
Nova Scotia Health Authority