Allison Miller1, Darcy S Reisman1,2, Sandra A Billinger3, Kari Dunning4, Sarah Doren4, Jaimie Ward3, Henry Wright2, Erin Wagner4, Daniel Carl4, Myron Gerson5, Oluwole Awosika6, Jane Khoury7, Brett Kissela6, Pierce Boyne8. 1. Department of Biomechanics and Movement Sciences Program, University of Delaware, Newark, DE, 19713, USA. 2. Department of Physical Therapy, University of Delaware, Newark, DE, 19713, USA. 3. Department of Physical Therapy and Rehabilitation Science, University of Kansas Medical Center, Kansas City, KS, USA. 4. Department of Rehabilitation, Exercise and Nutrition Sciences, University of Cincinnati, 3225 Eden Avenue, Cincinnati, OH, USA. 5. Departments of Cardiology and Internal Medicine, University of Cincinnati, Cincinnati, OH, USA. 6. Department of Neurology and Rehabilitation Medicine, University of Cincinnati, Cincinnati, OH, USA. 7. Division of Biostatistics and Epidemiology, Cincinnati Children's Hospital Medical Center, Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH, USA. 8. Department of Rehabilitation, Exercise and Nutrition Sciences, University of Cincinnati, 3225 Eden Avenue, Cincinnati, OH, USA. boynepe@ucmail.uc.edu.
Abstract
BACKGROUND: Stroke results in neurologic impairments and aerobic deconditioning that contribute to limited walking capacity which is a major barrier post-stroke. Current exercise recommendations and stroke rehabilitation guidelines recommend moderate-intensity aerobic training post-stroke. Locomotor high-intensity interval training is a promising new strategy that has shown significantly greater improvements in aerobic fitness and motor performance than moderate-intensity aerobic training in other populations. However, the relative benefits and risks of high-intensity interval training and moderate-intensity aerobic training remain poorly understood following stroke. In this study, we hypothesize that locomotor high-intensity interval training will result in greater improvements in walking capacity than moderate-intensity aerobic training. METHODS: Using a single-blind, 3-site randomized controlled trial, 50 chronic (> 6 months) stroke survivors are randomly assigned to complete 36 locomotor training sessions of either high-intensity interval training or moderate-intensity aerobic training. Main eligibility criteria are age 40-80 years, single stroke for which the participant received treatment (experienced 6 months to 5 years prior to consent), walking speed ≤ 1.0 m/s, able to walk at least 3 min on the treadmill at ≥ 0.13 m/s (0.3 mph), stable cardiovascular condition (American Heart Association class B), and the ability to walk 10 m overground without continuous physical assistance. The primary outcome (walking capacity) and secondary outcomes (self-selected and fast gait speed, aerobic fitness, and fatigue) are assessed prior to initiating training and after 4 weeks, 8 weeks, and 12 weeks of training. DISCUSSION: This study will provide fundamental new knowledge to inform the selection of intensity and duration dosing parameters for gait recovery and optimization of aerobic training interventions in chronic stroke. Data needed to justify and design a subsequent definitive trial will also be obtained. Thus, the results of this study will inform future stroke rehabilitation guidelines on how to optimally improve walking capacity following stroke. TRIAL REGISTRATION: ClinicalTrials.gov NCT03760016 . Registered on November 30, 2018.
RCT Entities:
BACKGROUND:Stroke results in neurologic impairments and aerobic deconditioning that contribute to limited walking capacity which is a major barrier post-stroke. Current exercise recommendations and stroke rehabilitation guidelines recommend moderate-intensity aerobic training post-stroke. Locomotor high-intensity interval training is a promising new strategy that has shown significantly greater improvements in aerobic fitness and motor performance than moderate-intensity aerobic training in other populations. However, the relative benefits and risks of high-intensity interval training and moderate-intensity aerobic training remain poorly understood following stroke. In this study, we hypothesize that locomotor high-intensity interval training will result in greater improvements in walking capacity than moderate-intensity aerobic training. METHODS: Using a single-blind, 3-site randomized controlled trial, 50 chronic (> 6 months) stroke survivors are randomly assigned to complete 36 locomotor training sessions of either high-intensity interval training or moderate-intensity aerobic training. Main eligibility criteria are age 40-80 years, single stroke for which the participant received treatment (experienced 6 months to 5 years prior to consent), walking speed ≤ 1.0 m/s, able to walk at least 3 min on the treadmill at ≥ 0.13 m/s (0.3 mph), stable cardiovascular condition (American Heart Association class B), and the ability to walk 10 m overground without continuous physical assistance. The primary outcome (walking capacity) and secondary outcomes (self-selected and fast gait speed, aerobic fitness, and fatigue) are assessed prior to initiating training and after 4 weeks, 8 weeks, and 12 weeks of training. DISCUSSION: This study will provide fundamental new knowledge to inform the selection of intensity and duration dosing parameters for gait recovery and optimization of aerobic training interventions in chronic stroke. Data needed to justify and design a subsequent definitive trial will also be obtained. Thus, the results of this study will inform future stroke rehabilitation guidelines on how to optimally improve walking capacity following stroke. TRIAL REGISTRATION: ClinicalTrials.gov NCT03760016 . Registered on November 30, 2018.
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