Exercise for Stroke Recovery

(FAST Trial)

Overseen By Sasha Moores

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Kansas Medical Center

Must be taking: Statins

Disqualifiers: Cardiac disease, Pulmonary disease, Ataxia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two exercise routines to determine which better improves fitness and blood flow in people who have had a stroke. One group will perform high-intensity interval training (HIIT), involving short bursts of intense exercise, while the other group will engage in moderate, steady exercise. The researchers aim to discover which type of exercise boosts aerobic fitness and supports brain and blood vessel health after a stroke. Individuals who had a stroke between 6 months and 15 years ago, can walk with assistive devices, and currently exercise less than 150 minutes a week might be suitable candidates. As a Phase 2 trial, this research measures the effectiveness of these exercise routines in an initial, smaller group, offering participants a chance to contribute to important findings.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, it does require that your blood pressure and statin medication doses remain stable for 30 days before joining the study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Studies have shown that both high-intensity interval training (HIIT) and moderate-intensity continuous training (MICT) are generally safe for people who have had a stroke.

Research indicates that HIIT is well-tolerated, with few serious side effects reported. Stroke survivors who tried HIIT demonstrated promising improvements in fitness levels without major safety concerns.

Similarly, guidelines recommend MICT for people recovering from a stroke to enhance aerobic capacity and mobility. This exercise type has been tested in stroke survivors and is considered safe based on current evidence.

Both exercise types aim to improve fitness and are under study to determine which is more effective for stroke recovery. Current findings suggest that both HIIT and MICT are safe options for stroke recovery. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about using exercise protocols like HIIT and MICT for stroke recovery because they offer dynamic, tailored approaches to rehabilitation. Unlike traditional physical therapy, which often involves lower intensity, steady-state exercises, HIIT introduces short bursts of high-intensity activity followed by brief rest periods, potentially enhancing cardiovascular health and neuroplasticity more effectively. MICT, on the other hand, provides a moderate, continuous exercise regimen that aligns with existing stroke recovery guidelines but aims to optimize results by maintaining a specific heart rate zone. Both approaches focus on maximizing recovery potential by directly targeting cardiovascular fitness and muscular endurance, which are crucial for regaining functionality after a stroke.

What evidence suggests that this trial's exercise treatments could be effective for stroke recovery?

This trial will compare High-Intensity Interval Training (HIIT) and Moderate Intensity Continuous Training (MICT) for stroke recovery. Research has shown that HIIT, one of the exercise options in this trial, can significantly enhance fitness and movement for stroke survivors. Studies have found that HIIT increases walking speed and improves heart and lung fitness more effectively than moderate exercise. It also aids in balance and cognitive skills, which are crucial for daily activities.

Meanwhile, MICT, another exercise option in this trial, is also recommended for enhancing overall fitness and movement after a stroke. Both HIIT and MICT are beneficial, but HIIT often results in greater improvements in fitness and movement. These findings can guide stroke recovery by helping to select the most suitable type and level of exercise for each individual. ^{2 3 4 6 7}

Who Is on the Research Team?

Sandra Billinger, PT, PhD,FAHA

Principal Investigator

KU Medical Center

Are You a Good Fit for This Trial?

This trial is for adults aged 20-85 who've had a stroke (ischemic or hemorrhagic) between 6 months and 5 years ago. Participants should be able to exercise minimally, walk with assistive devices without constant help, and not be very active currently. Excluded are those with severe spasticity, recent substance abuse, certain medical conditions like severe COPD or neurological diseases, pregnant women, recent hospitalizations for heart/lung issues, pacemakers that limit exercise, significant pain affecting daily life or depression.

Inclusion Criteria

I can understand and follow instructions and answer questions about the study.

I can walk with tools like a cane but don’t need someone to help me all the time.

I can safely do moderate exercise without health risks.

Exclusion Criteria

I need oxygen therapy for my COPD.

You have a pacemaker or defibrillator that restricts your ability to exercise.

I have severe leg stiffness because I can't exercise.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in a 4-week exercise program using a seated stepper, allocated to either moderate intensity continuous training (MICT) or high-intensity interval training (HIIT)

4 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of cerebral blood flow, gait speed, oxygen uptake, and vascular function

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Exercise HIIT
• Exercise MICT

Trial Overview

The study tests the effectiveness of high-intensity interval training (HIIT) versus moderate-intensity continuous training (MICT) on aerobic fitness in stroke survivors using a seated stepper device. It aims to find out which type and intensity of exercise best improve fitness levels and vascular health after a stroke.

How Is the Trial Designed?

Group I: High intensity, interval exercise (HIIT) Active Control 1 Intervention

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.

Group II: Moderate intensity, continuous training (MICT) Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Kansas Medical Center

Lead Sponsor

Trials

527

Recruited

181,000+

Published Research Related to This Trial

High-intensity interval training (HIIT) was found to be safe and feasible for patients with lacunar stroke, with no adverse events reported during the home-based intervention involving 71 participants.

While HIIT did not significantly improve cardiorespiratory fitness compared to usual care, it did increase the time spent on vigorous-intensity activity, suggesting potential benefits in physical activity levels for stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Home-Based High-Intensity Interval Training in Patients With Lacunar Stroke: A Randomized Controlled Trial. Steen Krawcyk, R., Vinther, A., Petersen, NC., et al.[2023]

In a study of 81 heart disease patients with very high cardiovascular risk, both moderate and high-intensity interval training (MIIT and HIIT) were found to be safe, with no adverse outcomes reported during the training.

While there were no statistically significant differences in overall exercise improvements between the training types, the HIIT group showed a trend towards greater improvements in exercise tolerance, suggesting it may be more effective than continuous moderate intensity training (MICT).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and improvement in exercise tolerance with interval training vs moderate-intensity continuous training in heart disease patient of very high cardiovascular risk. Pineda-García, AD., Lara-Vargas, JA., Ku-González, A., et al.[2022]

High-intensity interval training (HIIT) is as effective, if not more so, than traditional moderate-intensity continuous training (MICT) for patients with cardiovascular disease, based on a systematic review of 23 studies involving 1117 participants.

The safety profile of HIIT in cardiac rehabilitation is promising, with only one major cardiovascular adverse event reported per 17,083 training sessions, indicating that HIIT can be safely implemented in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-Intensity Interval Training for Patients With Cardiovascular Disease-Is It Safe? A Systematic Review. Wewege, MA., Ahn, D., Yu, J., et al.[2021]

High-intensity interval training (HIIT) has shown significant improvements in mobility and cardiorespiratory fitness in stroke survivors, based on a systematic review of six studies involving 140 participants.

While HIIT improved peak oxygen consumption compared to baseline, it was not significantly more effective than moderate intensity continuous exercise (MICE); however, it did show superior results in specific mobility tests like the 10-Meter Walk Test and Functional Ambulation Categories.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of High-Intensity Interval Training for Fitness and Mobility Post Stroke: A Systematic Review. Wiener, J., McIntyre, A., Janssen, S., et al.[2020]

This study will compare the effects of high-intensity interval training (HIIT) and moderate-intensity continuous training (MICT) on neuroplasticity and cardiovascular health in 80 participants with chronic stroke over 12 weeks, assessing outcomes like corticospinal excitability and motor function.

HIIT may offer a more effective alternative to MICT for achieving higher exercise intensities, which could enhance neuroplasticity and recovery in stroke patients, potentially leading to better rehabilitation outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intensity matters: protocol for a randomized controlled trial exercise intervention for individuals with chronic stroke. Rodrigues, L., Moncion, K., Eng, JJ., et al.[2022]

A 6-month exercise program combining high intensity interval training (HIIT) and moderate intensity continuous training (MICT) showed similar improvements in cardiorespiratory fitness (CRF) and mental health markers (anxiety and depression) compared to a standard MICT program in stroke or TIA patients, with both exercise groups outperforming a control group.

Both exercise programs were well-accepted by participants, and the addition of HIIT was found to be safe, indicating that HIIT can be effectively integrated into rehabilitation for stroke patients without compromising safety or efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Addition of high-intensity interval training to a moderate intensity continuous training cardiovascular rehabilitation program after ischemic cerebrovascular disease: A randomized controlled trial. Lapointe, T., Houle, J., Sia, YT., et al.[2023]

A preliminary randomized controlled trial involving 18 participants post-stroke indicated that high-intensity interval training (HIT) is feasible and well-accepted, with no serious adverse events reported during the 4-week intervention.

While HIT showed significant improvements in treadmill performance, only 30% of these gains translated to better overground walking speed, suggesting the need for further research to enhance the effectiveness of treadmill training for real-world mobility.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-Intensity Interval Training and Moderate-Intensity Continuous Training in Ambulatory Chronic Stroke: Feasibility Study. Boyne, P., Dunning, K., Carl, D., et al.[2018]

High-intensity interval training (HIT) may be more effective than conventional aerobic exercise for improving aerobic capacity and functional recovery in stroke patients, based on preliminary studies.

The review emphasizes the need for a structured approach to HIT protocols and highlights the importance of assessing safety, as there has been limited research on the safety of HIT specifically for poststroke individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-intensity interval training in stroke rehabilitation. Boyne, P., Dunning, K., Carl, D., et al.[2021]

High-intensity interval training (HIIT) has been shown to significantly improve various health outcomes, including cardiorespiratory fitness, muscle mass, and mental health indicators like anxiety and depression, across diverse populations, as evidenced by 33 systematic reviews involving both healthy individuals and those with health complications.

HIIT is considered safe, with no reported acute injuries and high adherence rates exceeding 80%, suggesting it is a feasible exercise option for many people.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can high-intensity interval training improve physical and mental health outcomes? A meta-review of 33 systematic reviews across the lifespan. Martland, R., Mondelli, V., Gaughran, F., et al.[2023]

High-intensity interval training (HIIT) led to more than double the improvement in cardiorespiratory fitness (V̇O2peak) compared to moderate-intensity continuous training (MICT) in stroke survivors, with a significant mean difference of 3.2 mL·kg-1·min-1 (P<0.001).

Both HIIT and MICT showed similar improvements in walking capacity (6-minute walk distance), but HIIT also resulted in a greater enhancement in ventilatory anaerobic threshold, indicating its superior efficacy in improving overall fitness post-stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of High-Intensity Interval Training and Moderate-Intensity Continuous Training in People With Poststroke Gait Dysfunction: A Randomized Clinical Trial. Marzolini, S., Robertson, AD., MacIntosh, BJ., et al.[2023]

In a study of 21 patients with myocardial infarction, both home-based high-intensity interval training (HIIT) and moderate-intensity continuous training (MICT) improved functional capacity and health outcomes over 12 weeks.

HIIT was found to be more effective than MICT in enhancing pulmonary function and lower extremity muscle strength, indicating that HIIT may offer additional benefits for patients recovering from a heart attack.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of home-based high-intensity interval training versus moderate-intensity continuous training in patients with myocardial infarction: a randomized controlled trial. Yakut, H., Dursun, H., Felekoğlu, E., et al.[2022]

Citations

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High-intensity exercise significantly improves 6MWT and BBS in stroke patients, but does not significantly affect TUG, VO2peak, 10MWT, or MoCA.

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sciencedirect.com

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Effects of High-Intensity Interval Training After Stroke (The ...

HIIT combined with standard care improved walking distance, balance, and executive function immediately after the intervention compared with standard care only.

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JAMA study finds that high-intensity interval training improves stroke patients' mobility more than moderate aerobic exercise · About the study.

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The HIIT Stroke Study found that stroke patients engaging in HIIT exhibited greater improvements in muscle strength compared to those ...