High Intensity Interval Training for People With Stroke Deficits: Optimizing the Exercise Intervention (The HIIT-Stroke Study)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 47
- 试验地点
- 2
- 主要终点
- Change in Six Minute Walk Test
研究概览
简要总结
The purpose of this study is to compare the effects of an exercise training strategy called high-intensity interval training (HIIT) to moderate intensity continuous exercise (MICE), on walking function and cardiovascular fitness in stroke patients. Hypothesis: HIIT will result in significantly greater benefit to fitness and mobility than MICE.
详细描述
Using a randomized design, the study will evaluate the effects of 3 HIT sessions combined with 2 MICE sessions per week on cardiovascular fitness and mobility compared to MICE training 5 days/week. Participants post-stroke will be randomly assigned to either MICE (5 days per week (d∙wk-1)) or combined HIIT (3 d∙wk-1) with MICE (2 d∙wk-1). Both groups will be exercising 5 times per week (walking on a treadmill with harness for fall protection); 3 times at the centre and 2 times at home. Outcome measures will be conducted before and after 24 weeks of training.
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
盲法说明
Only the outcome assessor is blinded for the cardiopulmonary exercise stress test but not for the 6-minute walk test.
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clinical diagnosis of stroke (hemorrhagic or ischemic),
- •ability to walk at least 100 m independently with or without an assistive device with no severe limitations due to pain,
- •living in the community at least 10 weeks post stroke (no upper limit) with a stroke-related motor impairment score of <7 on the Chedoke-McMaster Stroke Assessment scale of the leg or foot or with hemiparetic gait pattern,
- •no severe communicative aphasia or comprehensive aphasia as noted in in clinical reports or referral form
- •no orthopedic issues that may be aggravated by HIT
- •ability to provide informed consent
排除标准
- •severe uncontrolled hypertension or orthostatic blood pressure decrease of >20 mmHg
- •other cardiovascular morbidities which would limit exercise tolerance (e.g. horizontal or downsloping ST-segment depression >2 mm, symptomatic aortic stenosis, complex arrhythmias),
- •unstable angina,
- •severe proliferative retinopathy or uncontrolled blood glucose,
- •hypertrophic cardiomyopathy
- •lower extremity claudication
- •cognitive and/or behavioral issues limiting participation in exercise testing and training, prior unrelated neurological disorders or psychiatric illness
- •abdominal or inguinal hernia causing discomfort with routine activities.
- •Other issues will be considered case-by-case.
结局指标
主要结局
Change in Six Minute Walk Test
时间窗: 0, 24 weeks
This test measures the distance that an individual can quickly walk in a period of 6 minutes on a flat surface. Participants will complete one trial with the gait aide prescribed to them. The distance will be recorded. Participants can stop and rest or discontinue to the test at any time.
Change in Cardiovascular fitness - Peak oxygen uptake (VO2peak)
时间窗: 0, 24 weeks
A symptom-limited exercise test will be performed on a treadmill with a harness for fall protection using a ramp protocol. Breath-by-breath gas samples will be collected via calibrated metabolic cart to determine peak oxygen uptake.
次要结局
- VO2 during HIT and MICE(9 weeks and 24 weeks)
- Change in Dual task gait velocity(0, 24 weeks)
- Adherence(0 to 24 weeks)
- Adverse Events(0 to 24 weeks)
- Neuropsychological Test Battery (change over time)(0, 24 weeks)
- Patient satisfaction(24 weeks)
- Change in Brain Blood Flow response to exercise(9 weeks and 24 weeks)
- Muscle Oxygenation(0, 8 weeks, 12 weeks, 24 weeks)
研究者
Susan Marzolini
Principle Investigator
University Health Network, Toronto