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

50 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of the treatment Exercise HIIT and MICT for stroke recovery?

Research shows that high-intensity interval training (HIIT) can lead to greater improvements in fitness and walking ability after a stroke compared to moderate-intensity continuous training (MICT). HIIT has been found to significantly enhance cardiorespiratory fitness, which is important for overall recovery. ^{1 2 3 4 5}

Is exercise, including HIIT and MICT, safe for humans?

Research shows that high-intensity interval training (HIIT) and moderate-intensity continuous training (MICT) are generally safe for humans, including those with cardiovascular conditions and stroke. HIIT has a low rate of major adverse events and no acute injuries were reported in studies, making it a safe option for improving fitness. ^{1 6 7 8 9}

How does the treatment 'Exercise HIIT and MICT' differ from other treatments for stroke recovery?

Exercise HIIT (High-Intensity Interval Training) and MICT (Moderate-Intensity Continuous Training) are unique because they focus on improving cardiovascular fitness and promoting neuroplasticity (the brain's ability to reorganize itself) through varying exercise intensities. Unlike traditional continuous exercise, HIIT involves short bursts of intense activity followed by rest, which may lead to better fitness and mobility improvements post-stroke. ^{1 2 3 10 11}

Research Team

Sandra Billinger, PT, PhD,FAHA

Principal Investigator

KU Medical Center

Eligibility Criteria

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

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

I need oxygen therapy for my COPD.

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

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 (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]

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]

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]

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) 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]

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]

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]

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]

References

1. Switzerland 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. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

High-Intensity Interval Training and Moderate-Intensity Continuous Training in Ambulatory Chronic Stroke: Feasibility Study. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of High-Intensity Interval Training for Fitness and Mobility Post Stroke: A Systematic Review. [2020]

4. England 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. [2023]

5. Ireland 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. [2022]

6. England pubmed.ncbi.nlm.nih.gov

High-Intensity Interval Training for Patients With Cardiovascular Disease-Is It Safe? A Systematic Review. [2021]

7. Mexico 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. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Effect of Home-Based High-Intensity Interval Training in Patients With Lacunar Stroke: A Randomized Controlled Trial. [2023]

9. England 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. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Intensity matters: protocol for a randomized controlled trial exercise intervention for individuals with chronic stroke. [2022]

11. England pubmed.ncbi.nlm.nih.gov

High-intensity interval training in stroke rehabilitation. [2021]