Fitness Intervention Tiral for Stroke: Enhancing Walking Endurance Using Home Rehabilitation Programs
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Functional Walking Capacity (6 Minute (walk test)
研究概览
简要总结
The objective of this study is to evaluate, among persons who have completed the restorative phase of stroke and have ceased rehabilitation, the relative effectiveness in improving functional exercise capacity of two programs for continued care, a home-based general fitness training program using stationary cycling and a disability targeted, home-based exercise program to enhance mobility and walking competency. capacity compared with the "walking" group and that consequently the cycle group will achieve a higher quality of life.
A secondary objective is to explore factors associated with compliance with the exercise regimens. Previous research has indicated that cognitive-affective-behavioural profile is related to exercise activity in a number of populations including sedentary adults, older adults and patients with cardiovascular disease. As we anticipate that one of the mechanisms by which the cycling will result in an outcome better than the more traditional type of disability tailored exercise program is through greater compliance, this second objective is very relevant. This study will also address the impact of regular exercise on cardio-vascular risk factor profile.
详细描述
The specific clinical hypothesis to be tested is that, over a one year period, persons assigned to the general fitness "cycle" group will experience a greater increase in functional exercise
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single (Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •verified stroke requiring hospital admission (based on clinical and radiological evidence)
- •ability to walk a minimum of 10 meters independently, using an aid or orthotic, with or without supervision,
- •less than one year since the last cerebrovascular event at the time of recruitment,
- •discharge from active rehabilitation (usually around 3 to 4 months post-stroke but not less than 1 month) into the geographic study area of greater Montreal and greater Halifax.
排除标准
- •severe cognitive deficits as evaluated by the Telephone Version of the Mini-Mental State Examination such that the subject does not understand their participation in the study,
- •receptive aphasia as evaluated by the Canadian Neurological Scale48 or the treating speech therapist,
- •illness or disability precluding participation in either rehabilitation intervention.
- •failure to pass a standard cardiology orientated history and physical examination complemented by a baseline screening exercise stress test
结局指标
主要结局
Functional Walking Capacity (6 Minute (walk test)
时间窗: baseline, 1 month, 6 months, 12 months
次要结局
- Quality of Life (SF-36)(Baseline, 1 month, 6 month, 12 month)
研究者
Nancy Mayo
BSc(PT), MSc, PhD
McGill University