High Intensity Interval Training for People With Stroke Deficits (HIIT-Stroke)

University Health Network, Toronto

Status: Active, not recruiting

Conditions: Stroke

Treatments: Behavioral: High Intensity Interval Training; Behavioral: Moderate Intensity Continuous Exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT03006731

16-5760-DE

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 47 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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47 participants in 2 patient groups

High Intensity Training

Experimental group

Description:

High Intensity Interval Training patients will attend the centre 3 times/week for 24 weeks. All subjects will participate in MICE aerobic training 5 days/week in the first four weeks of the study to provide a foundation of fitness and endurance for the safe prescription of HIIT. Subsequently, the HIIT group will replace 3 MICE training days with 3 HIIT. HIIT sessions will include two 20 minute protocols; 30:60 second work:active rest ratio, and 120:180 second work:active rest ratio on a treadmill with a harness for fall protection. In addition to supervised exercise training (3 times/week), MICE will be conducted 2 times/week in the home/community, which has been shown to be both safe and effective

Treatment:

Behavioral: High Intensity Interval Training

Moderate Intensity Exercise

Active Comparator group

Description:

Moderate Intensity Continuous Exercise patients will attend the centre 3 times/week for 24 weeks. Participants will be progressed to 30 to 60 minutes of continuous exercise at the heart rate that occurred at the anaerobic threshold on the exercise test. Participants will exercise on a treadmill with a harness ofr fall protection. In addition to supervised exercise training (3 times/week), MICE will be conducted 2 times/week in the home/community by both cohorts.

Treatment:

Behavioral: Moderate Intensity Continuous Exercise