Exercise Training for Stroke Survivors

(HST2 Trial)

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen by Pierce Boyne, PT, DPT, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Cincinnati

Disqualifiers: Arrhythmia, Ischemia, Ataxia, Spasticity, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

People who had a stroke at least 6 months prior and who still have difficulty with walking will each be randomly assigned to receive either moderate or vigorous intensity walking exercise. Both protocols will be performed individually with a physical therapist for 45 minutes, 3x/week for 12 weeks. Measures including walking function will be assessed at baseline (PRE), after 4, 8 and 12 weeks of training (12WK) and at 3-month follow up (3moPOST), by raters who are unaware of the participant randomization.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment High-Intensity Interval Training for stroke survivors?

Research shows that High-Intensity Interval Training (HIIT) can improve walking ability and aerobic fitness more effectively than moderate-intensity aerobic training for stroke survivors. Studies have also found that HIIT is more effective than traditional aerobic exercise in improving fitness and mobility in other populations, such as healthy adults and people with heart disease. ^{1 2 3 4 5}

Is high-intensity interval training (HIIT) safe for stroke survivors?

Research indicates that high-intensity interval training (HIIT) is generally safe for stroke survivors, with studies showing no reported adverse events in patients with minor strokes and older adults. However, more research is needed to fully understand its safety in different populations. ^{1 2 6 7 8}

How does the treatment of high-intensity interval training (HIIT) differ from other treatments for stroke survivors?

High-intensity interval training (HIIT) is unique because it involves short bursts of intense exercise followed by rest periods, which can improve aerobic capacity and functional recovery more effectively than traditional moderate-intensity aerobic training. This approach has shown promise in enhancing fitness and mobility in stroke survivors, although its safety and specific protocols need further study. ^{1 2 3 5 9}

Research Team

Pierce Boyne, PT, DPT, PhD

Principal Investigator

University of Cincinnati

Eligibility Criteria

This trial is for individuals who had a stroke at least 6 months ago and are experiencing walking difficulties. They should be able to participate in physical therapy sessions three times a week for 12 weeks, with follow-up assessments.

Inclusion Criteria

I can walk on a treadmill for at least 3 minutes at a slow pace.

My heart condition is stable but I have limited exercise ability.

I have weakness on one side of my body due to a stroke.

Exclusion Criteria

Exercise testing uninterpretable for ischemia or arrhythmia (e.g. resting ECG abnormality that makes exercise ECG uninterpretable for ischemia and no other clinical testing from the past year available to rule out these conditions)

I am currently in physical therapy or a study to improve my walking.

Previous exposure to fast treadmill walking (>3 cumulative hours) in the past year

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either moderate or vigorous intensity walking exercise with a physical therapist for 45 minutes, 3 times a week for 12 weeks

12 weeks

36 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 3-month follow-up

3 months

1 visit (in-person)

Treatment Details

Interventions

• High-Intensity Interval Training (Behavioral Intervention)
• Moderate-Intensity Aerobic Training (Behavioral Intervention)

Trial Overview The HIT-Stroke Trial 2 is testing the effectiveness of two types of exercise: High-Intensity Interval Training (HIIT) versus Moderate-Intensity Aerobic Training (MIAT), on improving walking function after a stroke.

Participant Groups

Group I: High-Intensity Interval Training Experimental Treatment 1 Intervention

Group II: Moderate-Intensity Aerobic Training Active Control 1 Intervention

Who Is Running the Clinical Trial?

University of Cincinnati

Lead Sponsor

Trials

442

Recruited

639,000+

Dr. Greg Postel

University of Cincinnati

Chief Medical Officer since 2020

MD from Indiana University School of Medicine

Dr. Neville G. Pinto

University of Cincinnati

Chief Executive Officer since 2017

PhD in Chemistry from the University of Virginia

University of Delaware

Collaborator

Trials

167

Recruited

25,700+

Harry Jiannan Wang

University of Delaware

Chief Executive Officer since 2023

PhD in Business Administration from Pennsylvania State University

Dr. Kenneth Gene Yancey

University of Delaware

Chief Medical Officer

MD from Harvard Medical School

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Dr. Diana W. Bianchi

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Chief Executive Officer since 2016

MD from Stanford University

Dr. Alison Cernich

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Chief Medical Officer since 2020

PhD in Clinical Psychology from University of Maryland

University of Kansas Medical Center

Collaborator

Trials

527

Recruited

181,000+

Dr. Steve Stites

University of Kansas Medical Center

Chief Executive Officer

MD from University of Kansas School of Medicine

Dr. Matthias Salathe

University of Kansas Medical Center

Chief Medical Officer

MD from University of Kansas School of Medicine

Findings from Research

In a study involving 55 individuals with chronic stroke, high-intensity interval training (HIIT) led to greater improvements in walking capacity compared to moderate-intensity aerobic training (MAT), primarily due to faster training speeds and improvements in neuromotor gait function.

While HIIT resulted in higher heart rates and lactate levels, these factors did not correlate with improvements in walking distance; instead, prioritizing training speed and step count was found to be crucial for enhancing walking capacity post-stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Training parameters and longitudinal adaptations that most strongly mediate walking capacity gains from high-intensity interval training post-stroke. Boyne, P., Miller, A., Schwab, SM., et al.[2023]

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]

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]

This study involves 50 chronic stroke survivors and compares the effects of high-intensity interval training (HIIT) versus moderate-intensity aerobic training on walking capacity over 36 sessions, aiming to determine which method is more effective for improving mobility post-stroke.

The results will provide crucial insights into the optimal intensity and duration of exercise for stroke rehabilitation, potentially influencing future guidelines to enhance walking capacity and overall recovery in stroke survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Moderate-intensity exercise versus high-intensity interval training to recover walking post-stroke: protocol for a randomized controlled trial. Miller, A., Reisman, DS., Billinger, SA., 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]

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]

A scoping review of 69 studies on high-intensity interval training (HIIT) in older adults found that HIIT protocols are generally well-tolerated and can provide significant health benefits, particularly in improving cardiorespiratory fitness.

Most research has focused on healthy older adults, highlighting a need for larger studies and more investigation into HIIT's effects on older adults with various health conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-Intensity Interval Training in Older Adults: a Scoping Review. Marriott, CFS., Petrella, AFM., Marriott, ECS., et al.[2021]

High-intensity exercise significantly improves cardiorespiratory fitness in stroke survivors, as evidenced by increased peak oxygen uptake (VO2peak) and performance on the 6-minute walk test, based on a meta-analysis of 17 studies involving various exercise protocols.

The study found no significant difference in adverse events between high-intensity exercise and control groups, suggesting that this type of exercise may be a safe intervention for stroke survivors in cardiopulmonary rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of high-intensity exercise on cardiorespiratory fitness in stroke survivors: A systematic review and meta-analysis. Luo, L., Meng, H., Wang, Z., et al.[2022]

A study involving 71 patients with lacunar stroke showed that early home-based high-intensity interval training (HIIT) did not lead to long-term improvements in cardiorespiratory fitness over 12 months, despite initial increases in vigorous-intensity activity during the intervention.

Both the HIIT and usual care groups experienced a decline in vigorous-intensity activity back to baseline levels by 12 months, highlighting the need for strategies to maintain physical activity after stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-intensity training in patients with lacunar stroke: A one-year follow-up. Krawcyk, RS., Vinther, A., Petersen, NC., et al.[2023]

References

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

Training parameters and longitudinal adaptations that most strongly mediate walking capacity gains from high-intensity interval training post-stroke. [2023]

2. England pubmed.ncbi.nlm.nih.gov

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

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

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

4. England pubmed.ncbi.nlm.nih.gov

Moderate-intensity exercise versus high-intensity interval training to recover walking post-stroke: protocol for a randomized controlled trial. [2021]

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

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

6. Switzerland pubmed.ncbi.nlm.nih.gov

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

7. Switzerland pubmed.ncbi.nlm.nih.gov

High-Intensity Interval Training in Older Adults: a Scoping Review. [2021]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Effect of high-intensity exercise on cardiorespiratory fitness in stroke survivors: A systematic review and meta-analysis. [2022]

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

High-intensity training in patients with lacunar stroke: A one-year follow-up. [2023]