High Intensity Interval Training for People With Stroke Deficits: Optimizing the Exercise Intervention (The HIIT-Stroke Study)
High Intensity Interval Training for People With Stroke Deficits
Sponsors
Source
University Health Network, Toronto
Oversight Info
Has Dmc
No
Is Fda Regulated Drug
No
Is Fda Regulated Device
No
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.
Overall Status
Recruiting
Start Date
2017-03-01
Completion Date
2022-12-31
Primary Completion Date
2022-12-31
Phase
N/A
Study Type
Interventional
Primary Outcome
Measure |
Time Frame |
|
Change in Cardiovascular fitness - Peak oxygen uptake (VO2peak) |
0, 24 weeks |
|
Change in Six Minute Walk Test |
0, 24 weeks |
Secondary Outcome
Measure |
Time Frame |
|
Neuropsychological Test Battery (change over time) |
0, 24 weeks |
|
VO2 during HIT and MICE |
9 weeks and 24 weeks |
|
Change in Dual task gait velocity |
0, 24 weeks |
|
Adherence |
0 to 24 weeks |
|
Adverse Events |
0 to 24 weeks |
|
Patient satisfaction |
24 weeks |
|
Change in Brain Blood Flow response to exercise |
9 weeks and 24 weeks |
Enrollment
104
Condition
Intervention
Intervention Type
Behavioral
Intervention Name
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.
Arm Group Label
High Intensity Training
Other Name
HIIT
Intervention Type
Behavioral
Intervention Name
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.
Arm Group Label
Moderate Intensity Exercise
Other Name
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.
Gender
All
Minimum Age
N/A
Maximum Age
N/A
Healthy Volunteers
No
Overall Official
Last Name |
Role |
Affiliation |
|
Susan Marzolini, PhD |
Principal Investigator |
Toronto Rehabilitaiton Institute |
|
Paul Oh, MD |
Study Director |
Toronto Rehabilitation Institute |
Overall Contact
Location
Facility |
Status |
Contact |
|
Toronto Rehabilitation Institute - Rumsey Centre Toronto Ontario M4G 2V6 Canada |
Recruiting |
Location Countries
Country
Canada
Verification Date
2019-04-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Principal Investigator
Investigator Affiliation
University Health Network, Toronto
Investigator Full Name
Susan Marzolini
Investigator Title
Principle Investigator
Has Expanded Access
No
Condition Browse
Number Of Arms
2
Arm Group
Arm Group Label
High Intensity Training
Arm Group Type
Experimental
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 Group Label
Moderate Intensity Exercise
Arm Group Type
Active Comparator
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.
Firstreceived Results Date
N/A
Overall Contact Backup
Acronym
HIIT-Stroke
Patient Data
Sharing Ipd
No
Firstreceived Results Disposition Date
N/A
Study Design Info
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)
Study First Submitted
December 19, 2016
Study First Submitted Qc
December 27, 2016
Study First Posted
December 30, 2016
Last Update Submitted
April 16, 2019
Last Update Submitted Qc
April 16, 2019
Last Update Posted
April 18, 2019
ClinicalTrials.gov processed this data on December 13, 2019
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.