Moderate-Intensity Exercise Versus High-Intensity Interval Training to Recover Walking Post-Stroke

Study Overview
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Brief Summary
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The objective of this study is to determine the optimal training intensity and the minimum training duration needed to maximize immediate improvements in walking capacity in chronic stroke. A single-blind, phase II, 3-site randomized controlled trial has been planned. Fifty persons >6 months post stroke will randomize to either moderate-intensity aerobic locomotor training or high-intensity interval locomotor training; each for 45 minutes, 3x/week for up to 36 total sessions over approximately 12 weeks. Clinical measures of walking function, aerobic fitness, daily walking activity and quality of life will be assessed at baseline (PRE) and after 4, 8 and 12 weeks of training (POST-4WK, POST-8WK, POST-12WK).

Official Title
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Moderate-Intensity Exercise Versus High-Intensity Interval Training to Recover Walking Post-Stroke

Conditions
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Stroke

Intervention / Treatment
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* Behavioral: Moderate-Intensity Aerobic Training
* Behavioral: High-Intensity Interval Training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 40-80 years at time of consenting Single stroke for which participant sought treatment, 6 months to 5 years prior to consent date Walking speed <1.0 m/s on the 10-meter walk test Able to walk 10m over ground with assistive devices as needed and no continuous physical assistance from another person (guarding and intermittent assistance for loss of balance allowed) Able to walk at least 3 minutes on the treadmill at ≥0.13m/s (0.3 mph) Stable cardiovascular condition (AHA class B, allowing for aerobic capacity <6 metabolic equivalents) Able to communicate with investigators, follow a 2-step command and correctly answer consent comprehension questions Exclusion Criteria: Exercise testing uninterpretable for ischemia or arrhythmia (e.g. resting ECG abnormality that makes exercise ECG uninterpretable for ischemia and no other clinical testing from the past year available to rule out) Evidence of significant arrhythmia or myocardial ischemia on treadmill ECG graded exercise test in the absence of recent (past year) more definitive clinical testing (e.g. stress nuclear imaging) with negative result Hospitalization for cardiac or pulmonary disease within past 3 months Implanted pacemaker or defibrillator Significant ataxia or neglect (score of 2 on NIH stroke scale item 7 or 11) Severe lower limb spasticity (Ashworth >2) Recent history (<3 months) of illicit drug or alcohol abuse or significant mental illness Major post-stroke depression (Patient Health Questionnaire [PHQ-9] ≥ 10) in the absence of depression management by a health care provider Currently participating in physical therapy or another interventional study Recent botulinum toxin injection to the paretic lower limb (<3 months) or planning to have lower limb botulinum toxin injection in the next 4 months Foot drop or lower limb joint instability without adequate stabilizing device, as assessed by a physical therapist Clinically significant neurologic disorder other than stroke or unable to walk outside the home prior to stroke Other significant medical condition likely to limit improvement or jeopardize safety as assessed by a physical therapist (e.g. joint contracture, gait limited by pain) Pregnancy Previous exposure to fast treadmill walking (>3 cumulative hours) during clinical or research therapy in the past year

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Moderate-Intensity Aerobic Training<br> | Behavioral: Moderate-Intensity Aerobic Training<br>* Overground and treadmill walking with speed continuously adjusted to maintain a target heart rate of 40 +/- 5% heart rate reserve, progressing up to 55 +/- 5% heart rate reserve.<br>|
| Experimental: High-Intensity Interval Training<br> | Behavioral: High-Intensity Interval Training<br>* Overground and treadmill walking with 30 second bursts at maximum speed alternated with 30-60 second passive recovery periods. Intended to achieve a target average heart rate above 60% heart rate reserve.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Six-Minute Walk Test Distance | Total distance walked in 6 minutes in meters | Change Six-Minute Walk Test Distance from Baseline to 4 Weeks | 
| Six-Minute Walk Test Distance | Total distance walked in 6 minutes in meters | Change Six-Minute Walk Test Distance from Baseline to 8 Weeks | 
| Six-Minute Walk Test Distance | Total distance walked in 6 minutes in meters | Change Six-Minute Walk Test Distance from Baseline to 12 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comfortable Gait Speed | From 10-meter walk test, in meters per second | 4 ,8, 12 weeks | 
| Fast Gait Speed | From 10-meter walk test, in meters per second | 4 ,8, 12 weeks | 
| Aerobic Fitness | Oxygen consumption rate at ventilatory threshold during treadmill graded exercise test, in milliliters per kilogram body mass per minute | 4 ,8, 12 weeks | 
| PROMIS-Fatigue Scale | An 8-item self-report questionnaire about symptoms of fatigue. Each item is rated from 1-5, where higher scores indicate greater fatigue. A total score will be calculated by averaging the scores for each item. | 4 ,8, 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rehabilitation, Locomotion, Aerobic, Intensity, Dosing