High-Intensity Stepping Training for Stroke Recovery

(LRC Trial)

Overseen By Chris Henderson

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Indiana University

Disqualifiers: Uncontrolled cardiovascular, metabolic, respiratory, others

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

Compensation: Varies

Number of Visits: Unknown

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how high-intensity stepping exercises can aid recovery after a stroke. Researchers aim to understand the effects of these exercises on both movement and brain recovery, and whether they can improve rehabilitation outcomes. Participants will undergo observation for a period before beginning 3-4 months of high-intensity training. This trial suits individuals who experienced their first stroke within the last 15-30 days, have one-sided weakness, and are currently in a rehabilitation program. As an unphased trial, it offers participants the chance to contribute to groundbreaking research that could enhance stroke rehabilitation techniques.

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's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that high-intensity training is safe for stroke recovery?

Research shows that high-intensity exercise can be safe for people recovering from a stroke. Studies indicate that this type of exercise helps improve walking and balance without major side effects. For instance, one study found that high-intensity exercise led to better results in walking and balance tests for stroke patients.

Another study showed that high-intensity interval training (HIIT) increased walking distance and improved balance. These benefits occurred without significant issues. While the studies don't detail specific side effects, the overall evidence suggests that high-intensity training is generally well-tolerated.

For those considering a trial involving high-intensity training, this exercise has proven helpful and is usually safe for stroke recovery. Discuss any concerns with a doctor. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about high-intensity stepping training for stroke recovery because it offers a fresh approach compared to traditional methods like physical therapy and passive exercises. Unlike these standard treatments, which often focus on gentle, repetitive movements, high-intensity stepping training emphasizes vigorous activity that aims to boost neuroplasticity—the brain's ability to reorganize itself. This could lead to more significant improvements in mobility and independence for stroke survivors. Additionally, by potentially shortening the recovery timeline, this method might help patients regain their abilities more quickly, offering new hope for faster and more effective rehabilitation.

What evidence suggests that high-intensity training could be effective for stroke recovery?

Research has shown that high-intensity exercise can aid stroke recovery. Studies have found that this exercise significantly improves stroke patients' walking distance and balance. For instance, high-intensity interval training (HIT) increased walking distance and enhanced cognitive skills just eight weeks after initiation. Another study found that incorporating high-intensity stepping exercises in rehabilitation improved walking and balance. Additionally, programs with approximately 100 hours of intense motor rehabilitation have enhanced overall recovery for stroke patients. This trial will evaluate high-intensity training in two phases, each involving observational evaluations followed by 3-4 months of high-intensity training. These findings suggest that high-intensity training could be a promising method to support recovery after a stroke. ^{1 3 4 5 6}

Who Is on the Research Team?

Thomas G Hornby

Principal Investigator

Indiana University School of Medicine

Are You a Good Fit for This Trial?

The LRC trial is for individuals who have had their first stroke and are currently in inpatient rehabilitation. They must be able to understand simple commands, provide consent, and get medical clearance from a rehab doctor. Participants should have one-sided weakness (hemiparesis) and be within 15-30 days post-stroke.

Inclusion Criteria

I had a stroke less than 30 days ago.

I am currently in a hospital rehabilitation program.

I have had my first stroke.

Exclusion Criteria

I do not have severe heart, lung, or kidney diseases that limit my physical activity.

Absolute criteria for termination of exercise testing during initial and repeated ECG testing during graded exercise testing using ACSM guidelines

I had a condition affecting my ability to walk before my stroke.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Observational Evaluations

Participants undergo observational evaluations to assess neurological and locomotor recovery

6 months

Regular visits for assessments

High-Intensity Training (HIT)

Participants receive high-intensity training to improve locomotor function

3-4 months

Frequent training sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• High-Intensity Training

Trial Overview This study tests high-intensity stepping exercises designed for different situations to see if they can improve walking and neurological function after a stroke. It looks at how these exercises affect recovery during the early and late stages post-stroke.

How Is the Trial Designed?

Group I: Phase 2 Experimental Treatment 1 Intervention

Observational evaluations for 1 month followed by 3-4 months of high-intensity training (HIT)

Group II: Phase 1 Experimental Treatment 1 Intervention

Observational evaluations for 6 months followed by 3-4 months of high-intensity training (HIT)

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials

1,403

Recruited

655,000+

Rehabilitation Hospital of Indiana

Collaborator

Trials

13

Recruited

5,500+

Published Research Related to This Trial

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]

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]

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]

Stroke survivors often face long-term disabilities, and current rehabilitation practices do not provide enough intensity or dosage of training to promote significant recovery.

The review suggests various therapeutic strategies, such as constraint-induced movement therapy and robotics, that can enhance training intensity and dosage, potentially leading to better recovery outcomes for stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Revisiting dose and intensity of training: Opportunities to enhance recovery following stroke. Donnellan-Fernandez, K., Ioakim, A., Hordacre, B.[2022]

High-intensity exercise (HIE) significantly improves lower limb function in acute and subacute stroke patients, particularly enhancing performance in the 6-minute walk test and gait speed, based on a systematic review of seven randomized controlled trials.

The review found no major adverse events associated with HIE, suggesting it is a safe intervention for stroke rehabilitation, and supports its implementation over lower intensity exercises for better functional outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence of High-Intensity Exercise on Lower Limb Functional Outcomes and Safety in Acute and Subacute Stroke Population: A Systematic Review. Mah, SM., Goodwill, AM., Seow, HC., et al.[2023]

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]

The DOSE trial demonstrated that higher therapeutic intensity in physical therapy can significantly improve long-term walking outcomes after stroke, with participants achieving over double the steps and aerobic minutes compared to usual care.

A model developed from data of 25 individuals in inpatient rehabilitation provides specific targets for prescribing exercise based on walking impairment, predicting increases of 73 steps and 0.56 minutes of aerobic activity per session, which can help tailor rehabilitation programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Step Number and Aerobic Minute Exercise Prescription and Progression in Stroke: A Roadmap. Peters, S., Klassen, T., Schneeberg, A., et al.[2022]

High-intensity stepping training significantly improved walking capacity and balance in stroke patients compared to usual care, with participants taking an average of 5777 steps per day versus 3917 steps in the usual care group.

The high-intensity intervention led to clinically meaningful improvements in self-selected and fastest gait speeds, as well as balance outcomes, suggesting that early, intensive rehabilitation can enhance recovery post-stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of High-Intensity Stepping Training During Inpatient Stroke Rehabilitation Improves Functional Outcomes. Moore, JL., Nordvik, JE., Erichsen, A., 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12366500/

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

2. ahajournals.org ahajournals.org/doi/10.1161/STROKEAHA.124.043650?doi=10.1161/STROKEAHA.124.043650

High-Dose, High-Intensity Stroke Rehabilitation: Why Aren't ... Taken together, these 3 programs show that high-dose, high-intensity motor rehabilitation (≈100 hours) improves outcomes, even for patients with ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5046191/

High-Intensity Interval Training and Moderate ... High-intensity interval training (HIT) is a strategy that maximizes exercise intensity by using bursts of concentrated effort alternated with recovery periods.

4. 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 ...

5. ahajournals.org ahajournals.org/doi/10.1161/STROKEAHA.119.027450

Implementation of High-Intensity Stepping Training During ... Provision of high-intensity stepping training applied during inpatient rehabilitation resulted in significantly greater walking and balance outcomes.

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

High Intensity Interval Training POst-STroke (HIIT-POST) High intensity interval training (HIIT) is a mode of aerobic exercise that can increase neurotrophin concentration, improve cardiovascular health, and enhance ...