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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03006731
Recruitment Status : Recruiting
First Posted : December 30, 2016
Last Update Posted : January 18, 2020
Information provided by (Responsible Party):
Susan Marzolini, University Health Network, Toronto

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.

Condition or disease Intervention/treatment Phase
Stroke Behavioral: High Intensity Interval Training Behavioral: Moderate Intensity Continuous Exercise Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: High Intensity Interval Training for People With Stroke Deficits: Optimizing the Exercise Intervention (The HIIT-Stroke Study)
Actual Study Start Date : March 1, 2017
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 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
Behavioral: 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.
Other Name: HIIT

Active Comparator: 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.
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.
Other Names:
  • MICE
  • Standard

Primary Outcome Measures :
  1. Change in Cardiovascular fitness - Peak oxygen uptake (VO2peak) [ Time Frame: 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.

  2. Change in Six Minute Walk Test [ Time Frame: 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.

Secondary Outcome Measures :
  1. Neuropsychological Test Battery (change over time) [ Time Frame: 0, 24 weeks ]
    Two executive function measures to measure selective attention and executive inhibition processes as well as a measure to assess speed of processing will be used. We will also include Trails A and B, DKEFS verbal fluency, the Weschsler digit symbol coding assessment.

  2. VO2 during HIT and MICE [ Time Frame: 9 weeks and 24 weeks ]
    To determine the ability of patients to reach critical intensity thresholds during HIT training and MICE and to examine dose-response associations, the acute effects (time spent above the critical intensity levels) will be measured using an ambulatory oxygen monitor. Ventilatory values will be measured using the CORTEX Biophysik MetaMax®3X portable gas analyzer recorded every 10 seconds for calculation of the time spent above the critical levels.

  3. Change in Dual task gait velocity [ Time Frame: 0, 24 weeks ]
    This assessment will include four 10 metre walking tasks at maximal comfortable speed. Three minutes after the first two 10 metre trials, participants will be asked to repeat the walk with simultaneous serial 3 subtractions and then naming as many words as possible that begin with a certain letter of the alphabet [FAS]. The number of errors and time to complete the tasks will be recorded.

  4. Adherence [ Time Frame: 0 to 24 weeks ]
    Attendance and completion of home-based sessions measured via exercise diary

  5. Adverse Events [ Time Frame: 0 to 24 weeks ]
    Any adverse event or near miss is required to be reported as standard of care at Toronto Rehab/UHN.

  6. Patient satisfaction [ Time Frame: 24 weeks ]

  7. Change in Brain Blood Flow response to exercise [ Time Frame: 9 weeks and 24 weeks ]
    Transcarnial Doppler ultrasound of the MCA and simultaneous finger cuff blood pressure monitoring during exercise

  8. Muscle Oxygenation [ Time Frame: 0, 8 weeks, 12 weeks, 24 weeks ]
    Near Infrared Spectroscopy (NIRS) measurement of the vastus lateralis during rest and exercise.

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03006731

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Contact: Susan Marzolini, PhD (416) 597-3422 ext 5246
Contact: Suban Kangatharan, R Kin 416-597-3422 ext 5200

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Canada, Ontario
Toronto Rehabilitation Institute - Rumsey Centre Recruiting
Toronto, Ontario, Canada, M4G 2V6
Contact: Susan Marzolini, PhD    (416) 597-3422 ext 5246   
Contact: Noah Koblinsky, MSc    (416) 785-2500 ext 3363   
Sponsors and Collaborators
University Health Network, Toronto
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Principal Investigator: Susan Marzolini, PhD Toronto Rehabilitaiton Institute
Study Director: Paul Oh, MD Toronto Rehabilitation Institute

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Responsible Party: Susan Marzolini, Principle Investigator, University Health Network, Toronto Identifier: NCT03006731    
Other Study ID Numbers: 16-5760-DE
First Posted: December 30, 2016    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases