What side effects are associated with this type of intervention?

High-Intensity Interval Training (HIIT) and Moderate-Intensity Continuous Training (MICT) are common exercise regimens used to improve brain plasticity and cardiovascular health in stroke rehabilitation. The most common side effects of these treatments include muscle soreness, fatigue, and an increased risk of injury due to the high physical demands. Additionally, individuals may experience cardiovascular strain, particularly if they have pre-existing heart conditions. It is essential for patients to undergo these exercises under professional supervision to minimize risks and ensure safety.

What prior FDA approvals exist?

FDA-approved treatments for stroke primarily focus on acute management and secondary prevention. Acute treatments include thrombolytics like tissue plasminogen activator (tPA) to dissolve clots and mechanical thrombectomy to remove clots. For secondary prevention, antiplatelet agents (e.g., aspirin, clopidogrel), anticoagulants (e.g., warfarin, direct oral anticoagulants), and statins are commonly used. While exercise regimens like High-Intensity Interval Training (HIIT) and Moderate-Intensity Continuous Training (MICT) are not FDA-approved treatments, they are increasingly recognized for their benefits in stroke rehabilitation, particularly in enhancing brain plasticity and cardiovascular health.

What other types of research exist?

Promising novel alternatives to HIIT and MICT for stroke patients include: 1) Virtual reality-based rehabilitation, which can enhance engagement and provide tailored exercises to improve motor function and brain plasticity. 2) Robotics-assisted therapy, which offers precise, repetitive movements to aid in motor recovery and cardiovascular health. 3) Aquatic therapy, which reduces joint stress and provides resistance training beneficial for cardiovascular health and muscle strength. 4) Functional electrical stimulation (FES), which can improve muscle strength and coordination by stimulating muscle contractions through electrical impulses.

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Exercise Intensity for Stroke Rehabilitation

N/A

Recruiting

Led By Marc Roig, PhD

Research Sponsored by McGill University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Stroke of non-cardiogenic origin or tumor

Significant disability as determined by modified Rankin scale score <2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial compares two exercise programs, HIIT and MICT, for stroke survivors. HIIT involves short bursts of intense exercise, while MICT is continuous moderate exercise. The goal is to see which program better improves brain function and heart health. The study will also check if participants find HIIT enjoyable and motivating. High-intensity interval training (HIIT) has been shown to induce significant improvements in numerous physiological and health-related indices, often to a similar or superior extent compared to moderate-intensity continuous training (MICT).

Who is the study for?

This trial is for individuals who had their first stroke 6-60 months ago, can walk at least 10 meters (with or without help), and have a basic ability to follow instructions. It's not suitable for those with other serious health issues that make exercise unsafe, currently in another rehab program, or have pain worsened by exercise.

What is being tested?

The study compares two types of exercises over 12 weeks: Moderate-Intensity Continuous Training (MICT) and High-intensity Interval Training (HIIT). Both are done on a machine that works arms and legs. Researchers will check how these affect brain recovery, heart health, mood, motivation, and walking.

What are the potential side effects?

While the document doesn't list specific side effects, typical risks from moderate to high-intensity exercise may include muscle soreness, fatigue, shortness of breath during activity. The eligibility criteria suggest avoiding participants where exercise could lead to significant discomfort or risk.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had a stroke not caused by heart issues or due to a tumor.

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I have little to no disability from my condition.

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I have a condition that stops me from being able to exercise.

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My pain gets worse when I exercise.

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My heart health is classified as high risk by the American Heart Association.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Cortico-spinal excitability

Secondary study objectives

Arterial stiffness

Cardiorespiratory fitness

Diastolic resting blood pressure

+4 more

Other study objectives

Enjoyment

Gait speed

Motivation

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Moderate-intensity continuous trainingExperimental Treatment1 Intervention

Intensity will be determined using a combination of heart rate reserve (HRR, calculated as HRR= \[max HR - resting HR\] x \[% training\] + \[resting HR\]) and ratings of perceived exertion (RPE). The MICT protocol will be increased using a progression schedule previously used (initial intensity at 40% HRR (RPE=9-11), and progressed by 10% HRR every 4 weeks up to 60% HRR (RPE=13-14) will be maintained until the end of the intervention). A 3-minute warm-up and 2-minute cool-down will be performed at 30% HRR (RPE=9-11). The total duration of MICT, including warm-up and cool-down, will be 35 minutes.

Group II: High-intensity interval trainingExperimental Treatment1 Intervention

Intensity will be determined using a combination of heart rate reserve (HRR, calculated as HRR= \[max HR - resting HR\] x \[% training\] + \[resting HR\]) and ratings of perceived exertion (RPE). The protocol will involve 10 60-second intervals of high intensity interspersed with 9 60-second low-intensity intervals. The initial high intensity intervals will start at 80% of the HRR (RPE=14-17) and progress by 10% every 4 weeks. Low intensity intervals will be performed at 30% of HRR (RPE=9-11). Three-minute warm-up and 2-minute cool-down periods will be performed at 30% of HRR. Total HIIT time including warm-up and cool-down is 24 minutes.

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

High-Intensity Interval Training (HIIT) and Moderate-Intensity Continuous Training (MICT) are common exercise treatments for stroke rehabilitation. These exercises work by promoting brain plasticity, which is the brain's ability to reorganize itself by forming new neural connections. This is crucial for stroke patients as it helps in the recovery of motor functions and cognitive abilities that may have been impaired. Additionally, both HIIT and MICT improve cardiovascular health by enhancing blood flow and reducing the risk of further cardiovascular events, which is vital for stroke patients to prevent recurrent strokes and improve overall health outcomes.