Exercise Training for Stroke Survivors

(HST2 Trial)

Recruiting at 2 trial locations

Overseen By Madison Yeazell

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Cincinnati

Disqualifiers: Arrhythmia, Ischemia, Ataxia, Spasticity, others

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

Compensation: Varies

Number of Visits: 37

Duration: 12 weeks

156 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help stroke survivors improve their walking abilities. Participants will work with a physical therapist and will be randomly assigned to either moderate or high-intensity walking exercises. The goal is to determine which type of exercise better enhances walking function over 12 weeks. It suits those who had a stroke at least six months ago and still face difficulties walking but can manage short distances with or without assistance.

As an unphased trial, this study offers a unique opportunity for participants to contribute to valuable research that could enhance rehabilitation strategies for stroke survivors.

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.

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

Research has shown that both high-intensity interval training (HIIT) and moderate-intensity aerobic exercise are generally safe for people recovering from a stroke. Studies have found that stroke survivors can handle HIIT well, with no major safety issues. One study found that HIIT is safe for those who have had a stroke or heart attack, with only minor, unimportant differences in safety results.

Moderate-intensity aerobic exercise is also considered safe and helpful for stroke recovery. Research highlights its benefits in improving walking ability and heart health. This type of exercise can help lower blood pressure and improve how the body handles sugar, which is important for recovery after a stroke.

Both HIIT and moderate-intensity aerobic exercise appear to be safe ways to boost fitness and health after a stroke. However, performing these exercises under professional guidance is important to ensure safety and maximize benefits. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these exercise techniques for stroke survivors because they offer a fresh approach to rehabilitation. Unlike traditional, steady-paced exercise programs, High-Intensity Interval Training (HIIT) involves short bursts of intense activity followed by rest, potentially improving cardiovascular fitness and neuroplasticity more efficiently. Moderate-Intensity Aerobic Training, on the other hand, provides a gentler, sustained workout that can enhance endurance and overall health without overstraining the body. Both methods aim to boost recovery by using exercise as a tool to rewire and strengthen the brain and body, offering new hope for faster and more effective stroke rehabilitation.

What evidence suggests that this trial's exercise training protocols could be effective for stroke survivors?

This trial will compare High-Intensity Interval Training (HIIT) with Moderate-Intensity Aerobic Training for stroke survivors. Research has shown that HIIT can significantly enhance walking speed, balance, and overall fitness in individuals who have experienced a stroke. Specifically, after 8 weeks of HIIT, participants reported walking longer distances and having better balance. Meanwhile, moderate-intensity aerobic exercise has also been shown to aid thinking skills and walking. This exercise can improve the body's sugar management and lower blood pressure in stroke survivors. Both exercise types have positive effects, but HIIT might lead to greater improvements in fitness and mobility. ^{1 3 5 6 7}

Who Is on the Research Team?

Pierce Boyne, PT, DPT, PhD

Principal Investigator

University of Cincinnati

Are You a Good Fit for This Trial?

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

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

• High-Intensity Interval Training
• Moderate-Intensity Aerobic Training

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.

How Is the Trial Designed?

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+

University of Delaware

Collaborator

Trials

167

Recruited

25,700+

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

Collaborator

Trials

2,103

Recruited

2,760,000+

University of Kansas Medical Center

Collaborator

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]

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]

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]

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]

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 (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 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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12065947/

High Intensity Interval Training POst-STroke (HIIT-POST) The use of HIIT interventions following stroke has demonstrated improvements in cardiorespiratory fitness, walking speed, balance, and fatigue ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40684288/

High-intensity interval training is not just for athletes High-intensity interval training (HIIT) improves both physical and psychological health outcomes as described by people post-stroke.People with ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0003999321004366

Effects of High-Intensity Interval Training After Stroke (The ... Secondary results from the HIIT Stroke Study showed a significant increase in walking distance, balance, and executive function immediately after 8 weeks of ...

4. ahajournals.org ahajournals.org/doi/10.1161/STROKEAHA.124.046564

Cardiorespiratory Fitness Benefits of High-Intensity Interval ... Results have been promising, suggesting that HIIT may be superior for improving mobility, with the greatest gains in V̇O2peak achieved after long ...

5. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2025.1565118/full

Effects of high-intensity exercise on rehabilitation ... Conclusion: High-intensity exercise significantly improves 6MWT and BBS in stroke patients, but does not significantly affect TUG, VO2peak, ...

6. cureus.com cureus.com/articles/304667-impact-of-high-intensity-interval-training-hiit-on-patient-recovery-after-myocardial-infarction-and-stroke-a-fast-track-to-fitness

Impact of High-Intensity Interval Training (HIIT) on Patient ... They also consistently reported that HIIT is safe for post-MI and post-stroke patients, with statistically insignificant differences in the ...

7. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2025.1695243/full

The Safety and Efficacy of High-Intensity Interval Training ... Conclusions HIIT may be a safe and effective therapy for specific post-stroke patients, but more high-quality research is needed to confirm ...