Clinical trial NCT03006731: High Intensity Interval Training for People With Stroke Deficits
Official title: High Intensity Interval Training for People With Stroke Deficits: Optimizing the Exercise Intervention (The HIIT-Stroke Study)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2016-12-30
Enrollment: 47
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in Cardiovascular fitness - Peak oxygen uptake (VO2peak)
timeFrame: 0, 24 weeks
measure: Change in Six Minute Walk Test
timeFrame: 0, 24 weeks
Secondary outcomes:
measure: Neuropsychological Test Battery (change over time)
timeFrame: 0, 24 weeks
measure: VO2 during HIT and MICE
timeFrame: 9 weeks and 24 weeks
measure: Change in Dual task gait velocity
timeFrame: 0, 24 weeks
measure: Adherence
timeFrame: 0 to 24 weeks
measure: Adverse Events
timeFrame: 0 to 24 weeks
measure: Patient satisfaction
timeFrame: 24 weeks
measure: Change in Brain Blood Flow response to exercise
timeFrame: 9 weeks and 24 weeks
measure: Muscle Oxygenation
timeFrame: 0, 8 weeks, 12 weeks, 24 weeks
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto Rehabilitation Institute - Rumsey Centre
state: Ontario
Study officials:
affiliation: Toronto Rehabilitaiton Institute
name: Susan Marzolini, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Toronto Rehabilitation Institute
name: Paul Oh, MD
role: STUDY_DIRECTOR
References: