Fitness After Stroke Trial

Study Overview
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Brief Summary
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People living with stroke have very low aerobic fitness, which can negatively impact brain health. Identifying the best exercise which includes exercise stimulus type (interval, continuous) or intensity, how hard to exercise (moderate, high) that benefit aerobic fitness, vascular health, and the brain's main blood vessels after stroke are unknown. This study is designed to determine the preliminary efficacy of high-volume HIIT to moderate intensity exercise using a seated stepper exercise device that allows the arms and legs to move back and forth.

Detailed Description
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People with stroke often experience physical decline and aerobic fitness that can be reversed through exercise. Evidence has shown that participating in exercise benefits aerobic fitness and vascular health while less is known about brain health. However, the optimal exercise dose such as intensity and exercise type (continuous, interval) are not yet known. The long-term goal of this project is to develop and test strategies to be implemented in larger clinical trials to improve health in people living with stroke. For this preliminary efficacy trial, the Investigator will enroll 50 participants with chronic stroke, age 20-85 years, into a 4-week exercise program. Participants will be allocated to one of the following groups using minimization, a type of randomization based on the lower extremity Fugl-Meyer score: 1) moderate intensity continuous training (MICT), that serves as the control, or 2) high-intensity interval training (HIIT). Exercise will be performed on a recumbent stepper. The Investigator will: Assess the preliminary efficacy of HIIT on aerobic fitness (Aim 1), cerebrovascular hemodynamics (Aim 2), and vascular function (Aim 3). Current exercise recommendations for stroke use general exercise prescription principles for older adults and are not grounded on data generated from large, well-designed, randomized controlled trials in stroke. If aerobic exercise could be proven to reduce the number of years of life lived with disability, it would offer a key strategy for: 1) minimizing dependence on caregiver support, 2) reducing overall healthcare costs, and 3) extending quality of life for individuals after stroke. This proposed trial will address an important gap in knowledge for both the scientific and clinical communities and provide essential data that will contribute to future exercise prescription recommendations focused on stroke.

Official Title
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Investigating Exercise Prescription Parameters on Aerobic Fitness and Vascular Health After Stroke: A Pilot Study

Conditions
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Stroke, Stroke, Ischemic, Stroke Hemorrhagic

Intervention / Treatment
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* Behavioral: Exercise MICT
* Behavioral: Exercise HIIT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Both sexes between the age of 20-85 years at time of consent Chronic ischemic or hemorrhagic stroke 6 months to 5 years at consent. People with stroke and newly diagnosed cardiovascular complications had >50% prevalence of recurrent stroke at 5 years. Index stroke or recurrent stroke on same side as index stroke will be allowed. Ability to walk over ground with assistive devices and no continuous physical assistance from another person to perform tests for gait speed and six-minute walk test Exercise continuously for minimum of 30 watts for 3 minutes on the recumbent stepper to demonstrate ability to perform the exercise test. No aerobic exercise contraindications or other safety/physical concerns during the submaximal exercise test. Able to communicate with investigators, follow 2-step command & correctly answer consent comprehension questions Currently participating in less than 150 minutes of physical activity/week assessed by the Rapid Assessment of Physical Activity Stable blood pressure & statin medication doses for 30 days prior to enrollment due to effects on vascular health/hemodynamics Exclusion Criteria: Hospitalization for cardiac or pulmonary disease within past 3 months Implanted pacemaker or defibrillator limiting exercise performance Significant ataxia or neglect (score of 2 on NIH stroke scale item 7 or 11) Reported pain that limits or interferes with activities of daily living and physical activity/exercise Severe LE spasticity (Ashworth >2) due to inability to exercise Recent history (<3 months) of illicit drug or alcohol abuse or diagnosis of significant mental illness Major post-stroke depression (Patient Health Questionnaire, PHQ-9 ≥ 1084) Currently participating in physical therapy targeting lower extremity function or another interventional study that may influence study outcomes Other significant neurologic, orthopedic or peripheral vascular conditions that would limit exercise participation Oxygen-dependent chronic obstructive pulmonary disease Diagnosis of other neurological disease (Multiple Sclerosis, Alzheimer's disease, Parkinson's disease) Self report pregnancy

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 85 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
Interventional Model Description: The Investigator will use an adaptive randomization design called minimization to ensure balance across groups. Intervention arms include: Moderate intensity, continuous training exercise High intensity, interval training exercise
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Moderate intensity, continuous training (MICT)<br>After a 5-minute warm-up at 30% peak watts, MICT will consist of continuous exercise for 25 minutes at 55% of peak watts (range: 45%-65%). The average heart rate for each individual session should not exceed 70% (60-70%) of HR maximum to align with current exercise recommendations for stroke. An active cool-down (20% peak workload) at comfortable stepping pace occurs immediately after the intervention. | Behavioral: Exercise MICT<br>* Standard of care, exercise recommendations for people with stroke<br>* Other names: aerobic exercise;|
| Active Comparator: High intensity, interval exercise (HIIT)<br>After the 5-minute warm-up at 30% peak watts, HIIT will consist of repeated 1-minute, high intensity bursts (on interval) alternated with 1-minute interval recovery (off interval) for 25 minutes. The on interval will begin at 70% of peak watts (range: 65%-95%) followed by the off interval at 10% of peak watts. The average HR for the on intervals will not exceed 85% age predicted maximum (75-85%). There will be 13 minutes of on and 12 minutes of off interval exercise. An active cool-down (20% peak workload) at comfortable stepping pace occurs immediately after the intervention. | Behavioral: Exercise HIIT<br>* The HIIT protocol consists of Short Interval, High Volume exercise at 1-minute exercise bouts followed by 1-minute active recovery for 25 minutes.<br>* Other names: HIIT, aerobic exercise, anaerobic exercise;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxygen uptake (VO2) | Assessing change in oxygen uptake during a submaximal exercise test | Baseline, 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Middle cerebral artery velocity | Assessing change in middle cerebral artery velocity response to an acute exercise bout | Baseline, 4 weeks | 
| Middle cerebral artery velocity at rest | Assessing change in middle cerebral artery velocity during a rest condition | Baseline, 4 weeks | 
| Flow-mediated Dilation | Endothelial vascular function | Baseline, 4 weeks | 
| Pulse Wave Velocity | Arterial stiffness | Baseline, 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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exercise, cerebrovascular, cardiovascular, walking, aerobic fitness, brain