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

Primary Purpose

Stroke

Status
Active
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
High Intensity Interval Training
Moderate Intensity Continuous Exercise
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Toronto Rehabilitation Institute - Rumsey Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

High Intensity Training

Moderate Intensity Exercise

Arm 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

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.

Outcomes

Primary Outcome Measures

Change in Cardiovascular fitness - Peak oxygen uptake (VO2peak)
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
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

Neuropsychological Test Battery (change over time)
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
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
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
Attendance and completion of home-based sessions measured via exercise diary
Adverse Events
Any adverse event or near miss is required to be reported as standard of care at Toronto Rehab/UHN.
Patient satisfaction
questionnaire
Change in Brain Blood Flow response to exercise
Transcarnial Doppler ultrasound of the MCA and simultaneous finger cuff blood pressure monitoring during exercise
Muscle Oxygenation
Near Infrared Spectroscopy (NIRS) measurement of the vastus lateralis during rest and exercise.

Full Information

First Posted
December 19, 2016
Last Updated
May 5, 2023
Sponsor
University Health Network, Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT03006731
Brief Title
High Intensity Interval Training for People With Stroke Deficits
Acronym
HIIT-Stroke
Official Title
High Intensity Interval Training for People With Stroke Deficits: Optimizing the Exercise Intervention (The HIIT-Stroke Study)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
July 31, 2022 (Actual)
Study Completion Date
August 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Health Network, Toronto

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
Only the outcome assessor is blinded for the cardiopulmonary exercise stress test but not for the 6-minute walk test.
Allocation
Randomized
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High Intensity Training
Arm Type
Experimental
Arm 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
Arm Title
Moderate Intensity Exercise
Arm Type
Active Comparator
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
High Intensity Interval Training
Other Intervention Name(s)
HIIT
Intervention Description
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
Intervention Name(s)
Moderate Intensity Continuous Exercise
Other Intervention Name(s)
MICE, Standard
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Cardiovascular fitness - Peak oxygen uptake (VO2peak)
Description
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.
Time Frame
0, 24 weeks
Title
Change in Six Minute Walk Test
Description
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.
Time Frame
0, 24 weeks
Secondary Outcome Measure Information:
Title
Neuropsychological Test Battery (change over time)
Description
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.
Time Frame
0, 24 weeks
Title
VO2 during HIT and MICE
Description
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.
Time Frame
9 weeks and 24 weeks
Title
Change in Dual task gait velocity
Description
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.
Time Frame
0, 24 weeks
Title
Adherence
Description
Attendance and completion of home-based sessions measured via exercise diary
Time Frame
0 to 24 weeks
Title
Adverse Events
Description
Any adverse event or near miss is required to be reported as standard of care at Toronto Rehab/UHN.
Time Frame
0 to 24 weeks
Title
Patient satisfaction
Description
questionnaire
Time Frame
24 weeks
Title
Change in Brain Blood Flow response to exercise
Description
Transcarnial Doppler ultrasound of the MCA and simultaneous finger cuff blood pressure monitoring during exercise
Time Frame
9 weeks and 24 weeks
Title
Muscle Oxygenation
Description
Near Infrared Spectroscopy (NIRS) measurement of the vastus lateralis during rest and exercise.
Time Frame
0, 8 weeks, 12 weeks, 24 weeks

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan Marzolini, PhD
Organizational Affiliation
Toronto Rehabilitaiton Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Paul Oh, MD
Organizational Affiliation
Toronto Rehabilitation Institute
Official's Role
Study Director
Facility Information:
Facility Name
Toronto Rehabilitation Institute - Rumsey Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4G 2V6
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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High Intensity Interval Training for People With Stroke Deficits

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