High Intensity Interval Training for People With Stroke Deficits (HIIT-Stroke)
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|ClinicalTrials.gov Identifier: NCT03006731|
Recruitment Status : Recruiting
First Posted : December 30, 2016
Last Update Posted : January 18, 2020
|Condition or disease||Intervention/treatment||Phase|
|Stroke||Behavioral: High Intensity Interval Training Behavioral: Moderate Intensity Continuous Exercise||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||104 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Adherence [ Time Frame: 0 to 24 weeks ]Attendance and completion of home-based sessions measured via exercise diary
- 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.
- Patient satisfaction [ Time Frame: 24 weeks ]questionnaire
- 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
- Muscle Oxygenation [ Time Frame: 0, 8 weeks, 12 weeks, 24 weeks ]Near Infrared Spectroscopy (NIRS) measurement of the vastus lateralis during rest and exercise.
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 ClinicalTrials.gov identifier (NCT number): NCT03006731
|Contact: Susan Marzolini, PhD||(416) 597-3422 ext firstname.lastname@example.org|
|Contact: Suban Kangatharan, R Kin||416-597-3422 ext email@example.com|
|Toronto Rehabilitation Institute - Rumsey Centre||Recruiting|
|Toronto, Ontario, Canada, M4G 2V6|
|Contact: Susan Marzolini, PhD (416) 597-3422 ext 5246 firstname.lastname@example.org|
|Contact: Noah Koblinsky, MSc (416) 785-2500 ext 3363 email@example.com|
|Principal Investigator:||Susan Marzolini, PhD||Toronto Rehabilitaiton Institute|
|Study Director:||Paul Oh, MD||Toronto Rehabilitation Institute|