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Clinical Trials/NCT03006731
NCT03006731
Active, not recruiting
Not Applicable

High Intensity Interval Training for People With Stroke Deficits: Optimizing the Exercise Intervention (The HIIT-Stroke Study)

University Health Network, Toronto1 site in 1 country47 target enrollmentMarch 1, 2017
ConditionsStroke

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
University Health Network, Toronto
Enrollment
47
Locations
1
Primary Endpoint
Change in Six Minute Walk Test
Status
Active, not recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 1, 2017
End Date
August 31, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Susan Marzolini

Principle Investigator

University Health Network, Toronto

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.

Outcomes

Primary Outcomes

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.

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.

Secondary Outcomes

  • 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)
  • Neuropsychological Test Battery (change over time)(0, 24 weeks)
  • Patient satisfaction(24 weeks)
  • Change in Brain Blood Flow response to exercise(9 weeks and 24 weeks)
  • Muscle Oxygenation(0, 8 weeks, 12 weeks, 24 weeks)

Study Sites (1)

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