High Intensity Interval Training for People With Stroke Deficits

NCT ID: NCT03006731

Last Updated: 2023-05-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 47 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-01
• Study Completion Date: 2023-08-31

Brief Summary

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.

Detailed 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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

High Intensity Training

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

Group Type: EXPERIMENTAL

High Intensity Interval Training

Intervention Type: BEHAVIORAL

Supervised HIIT sessions will be conducted on a treadmill at Toronto Rehab's Cardiac Rehabilitation and Secondary Prevention Program. During each of the three supervised HIIT sessions each week, subjects will be prescribed 2 protocols with a combination of short to moderate duration exercise of near maximal intensity alternating longer periods of active recovery. The total duration for each HIT session will be approximately 20 minutes with an additional 5 minutes warm-up and cool down period.

Moderate Intensity Exercise

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.

Group Type: ACTIVE_COMPARATOR

Moderate Intensity Continuous Exercise

Intervention Type: BEHAVIORAL

MICE sessions represent the standard of care exercise prescription at TRI. Participants will be instructed to complete 20-60 minutes of continuous aerobic exercise at or around the ventilatory anaerobic threshold achieved on the cardiopulmonary exercise test.

Interventions

High Intensity Interval Training

Supervised HIIT sessions will be conducted on a treadmill at Toronto Rehab's Cardiac Rehabilitation and Secondary Prevention Program. During each of the three supervised HIIT sessions each week, subjects will be prescribed 2 protocols with a combination of short to moderate duration exercise of near maximal intensity alternating longer periods of active recovery. The total duration for each HIT session will be approximately 20 minutes with an additional 5 minutes warm-up and cool down period.

Intervention Type: BEHAVIORAL

Moderate Intensity Continuous Exercise

MICE sessions represent the standard of care exercise prescription at TRI. Participants will be instructed to complete 20-60 minutes of continuous aerobic exercise at or around the ventilatory anaerobic threshold achieved on the cardiopulmonary exercise test.

Intervention Type: BEHAVIORAL

Other Intervention Names

HIIT; MICE; Standard

Eligibility Criteria

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Susan Marzolini

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Susan Marzolini, PhD

Role: PRINCIPAL_INVESTIGATOR

Toronto Rehabilitaiton Institute

Paul Oh, MD

Role: STUDY_DIRECTOR

Toronto Rehabilitation Institute

Locations

Toronto Rehabilitation Institute - Rumsey Centre

Toronto, Ontario, Canada

Countries

Canada

References

Marzolini S, Robertson AD, MacIntosh BJ, Corbett D, Anderson ND, Brooks D, Koblinsky N, Oh P. Effect of High-Intensity Interval Training and Moderate-Intensity Continuous Training in People With Poststroke Gait Dysfunction: A Randomized Clinical Trial. J Am Heart Assoc. 2023 Nov 21;12(22):e031532. doi: 10.1161/JAHA.123.031532. Epub 2023 Nov 10.

Reference Type: DERIVED

PMID: 37947080 (View on PubMed)

Other Identifiers

16-5760-DE

Identifier Type: -

Identifier Source: org_study_id