High-Intensity Training for Stroke

(F-ITT Trial)

Overseen By Thomas G Hornby, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Indiana University

Must not be taking: Botox

Disqualifiers: Cerebellar ataxia, Uncontrolled cardiopulmonary, others

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

Compensation: Varies

Number of Visits: 18

Duration: 6-12 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine the optimal frequency of high-intensity walking training to improve walking after a stroke. Researchers will compare outcomes between participants who train more frequently over a shorter period and those who train less frequently over a longer period. The focus is on enhancing independent walking ability. Ideal candidates for this trial are individuals with one-sided weakness from a stroke that occurred over six months ago and who can walk using a brace or assistive device without assistance. As an unphased trial, this study offers participants the chance to contribute to valuable research that could enhance rehabilitation strategies for stroke survivors.

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

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more details.

What prior data suggests that high-intensity gait training and physical activity coaching are safe for stroke patients?

Research has shown that high-intensity walking exercises are generally safe for people recovering from a stroke. Studies have found that this type of exercise improves walking and balance without causing harm. Participants in these programs often experience better movement outcomes.

Coaching for physical activity also appears safe. One study found no evidence of injuries or health issues from this kind of coaching. Exercising with coaching support provides a safe way to aid recovery after a stroke.

Overall, both high-intensity walking exercises and physical activity coaching have demonstrated positive results for safety and effectiveness in past research. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how the intensity and frequency of physical activity coaching can impact recovery after a stroke. Unlike standard rehabilitation options, which often focus on lower intensity and frequency, this trial is testing high-intensity gait training delivered in two different schedules: a shorter, more concentrated 6-week period, and a longer 12-week period. The goal is to determine if more frequent, high-intensity sessions can accelerate improvements in mobility and overall recovery. By experimenting with these different approaches, they hope to find more effective ways to help stroke survivors regain their independence faster.

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

This trial will compare high-intensity gait training with physical activity coaching for stroke survivors. Studies have shown that high-intensity gait training, one of the treatments participants may receive, greatly improves walking and balance. This training involves intense stepping exercises and leads to better movement, enabling more individuals to return home from rehabilitation. In contrast, physical activity coaching, another treatment option in this trial, has produced mixed results. While regular coaching helps stroke survivors stay active and reduce certain health risks, it hasn't consistently improved movement skills compared to standard care. Overall, high-intensity gait training appears more effective in enhancing mobility after a stroke. ^{1 2 3 6 7}

Who Is on the Research Team?

Thomas G Hornby, PhD

Principal Investigator

Indiana University

Are You a Good Fit for This Trial?

This trial is for individuals aged 18-85 who have had a stroke more than 6 months ago, can follow simple instructions, weigh less than 350 pounds, and can walk at certain speeds with or without braces or walking aids. They must also be medically cleared to participate.

Inclusion Criteria

Weight < 350 pounds

Unilateral deficits following stroke > 6 months prior; individuals > 4 months post-stroke eligible for consenting, final eligibility and potential enrollment after > 6 months

My leg movement is severely limited.

Exclusion Criteria

I am currently in a physical therapy program.

I have coordination problems due to cerebellar ataxia.

I don't have heart, lung, or metabolic diseases that limit my ability to exercise, nor do I have a history of frequent bone fractures or injuries that would affect my ability to move.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Testing

Baseline testing to confirm eligibility and assess initial locomotor and community outcomes

1 week

Treatment

Participants receive high-intensity gait training and activity coaching

6-12 weeks

18 visits (in-person)

Follow-up

Participants are monitored for locomotor and community outcomes after treatment

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• High-intensity gait training
• Physical activity coaching

Trial Overview The study is testing how often people should do high-intensity gait training combined with home walking programs to improve their ability to walk after having a stroke. It's a pilot study which means it's an early test of this approach.

How Is the Trial Designed?

Group I: High frequency Experimental Treatment 2 Interventions

Individuals will receive up to 18 visits of high-intensity gait training and activity coaching over 6 weeks

Group II: Low frequency Active Control 2 Interventions

Individuals will receive up to 18 visits of high-intensity gait training and activity coaching over 12 weeks

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

Published Research Related to This Trial

A high-intensity task-oriented training program significantly improved gait speed and walking capacity in patients with subacute stroke compared to a low-intensity physiotherapy program, as shown by results from the 10-metre timed walking test and the six-minute walk test.

The study involved 44 stroke patients and demonstrated that while the high-intensity training was feasible and effective for improving gait, it did not show significant differences in balance measures, suggesting that future research should also assess physical fitness and energy expenditure during walking.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a high-intensity task-oriented training on gait performance early after stroke: a pilot study. Outermans, JC., van Peppen, RP., Wittink, H., et al.[2022]

A high-intensity treadmill and self-management program for stroke survivors during inpatient rehabilitation was found to be feasible, with participants completing an average of 10 sessions and achieving 94% compliance with the training intensity, all without adverse events.

After 8 weeks, participants significantly increased their physical activity by nearly 2750 steps per day, improved walking distance by 110 meters, and enhanced cardiorespiratory fitness, with these benefits maintained at a 26-week follow-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-intensity treadmill training and self-management for stroke patients undergoing rehabilitation: a feasibility study. Brauer, SG., Kuys, SS., Paratz, JD., et al.[2021]

Cardiorespiratory training significantly reduces disability in stroke survivors, with a moderate effect size, indicating that such exercise can improve mobility and balance during rehabilitation.

The study found no serious adverse events associated with exercise, suggesting that physical training is a safe intervention for stroke survivors, although it did not influence mortality rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical fitness training for stroke patients. Saunders, DH., Sanderson, M., Hayes, S., et al.[2023]

The Fitbit One accurately measures walking steps in stroke rehabilitation patients, showing a strong correlation with the gold standard StepWatch Activity Monitor across various walking speeds during 471 monitored therapy sessions.

The mean error of the Fitbit One in counting steps was relatively low, ranging from 4.4% to 10.9% depending on walking velocity, indicating its potential as a reliable tool for monitoring exercise intensity in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Consumer-Based Physical Activity Monitor as a Practical Way to Measure Walking Intensity During Inpatient Stroke Rehabilitation. Klassen, TD., Semrau, JA., Dukelow, SP., et al.[2018]

Progressive strength and low-intensity aerobic exercise programs lasting 3 to 6 months can significantly improve motor function, strength, balance, and overall fitness in stroke survivors without worsening spasticity.

Increasing access to community-based physical activity programs is crucial for preventing deconditioning and enhancing the quality of life for individuals recovering from a stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Adapted exercise important after stroke. Acute and long-term effects of different training programs]. Engardt, M., Grimby, G.[2017]

In a randomized controlled trial involving 209 elderly participants (average age 80), a home-based exercise program was found to be generally safe, with 151 adverse events reported, affecting 47% of participants.

Despite the program's safety, 14% of the adverse events were serious, highlighting that high levels of pre-existing morbidity in this population can pose challenges to maintaining consistent exercise participation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events in mobility-limited and chronically ill elderly adults participating in an exercise intervention study supported by general practitioner practices. Hinrichs, T., Bücker, B., Wilm, S., et al.[2015]

A systematic review of 38 studies involving exercise in adults with spinal cord injury found no serious adverse events (AEs) associated with cardiovascular exercise, suggesting it is safe when following guidelines.

The only notable AEs were musculoskeletal issues related to functional electrical stimulation (FES) walking, while volitional exercise showed very few AEs, indicating that exercise can be beneficial for individuals with spinal cord injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events in cardiovascular-related training programs in people with spinal cord injury: a systematic review. Warms, CA., Backus, D., Rajan, S., et al.[2021]

In a 1.5-year study involving 274 male veterans with cardiovascular disease risk factors, only one serious adverse event (atrial fibrillation) occurred, indicating that a progressive walking program can be safely recommended for high-risk individuals.

While minor musculoskeletal issues were common, over half of the reported adverse events were unrelated to the exercise program, highlighting the need for strategies to help individuals with chronic illnesses safely resume physical activity after any health setbacks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events among high-risk participants in a home-based walking study: a descriptive study. Goodrich, DE., Larkin, AR., Lowery, JC., et al.[2022]

In a study of 200 patients with moderate to severe subacute stroke, those who underwent aerobic training experienced a higher rate of serious adverse events compared to those in the relaxation control group, with an incident rate ratio of 1.70.

The occurrence of serious adverse events in the aerobic training group was significantly influenced by pre-existing conditions such as diabetes mellitus and atrial fibrillation, indicating that these factors may increase risk and warrant further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical Fitness Training in Patients with Subacute Stroke (PHYS-STROKE): Safety analyses of a randomized clinical trial. Rackoll, T., Nave, AH., Ebinger, M., et al.[2022]

In a study of 3,298 participants, including 562 aged 80 and older, physical inactivity was found to significantly increase the risk of stroke, particularly in those aged 80 and above, with an adjusted hazard ratio of 1.60.

The findings suggest that promoting physical activity in older adults could be an effective strategy to reduce stroke risk, highlighting physical inactivity as a treatable risk factor in this vulnerable age group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical inactivity is a strong risk factor for stroke in the oldest old: Findings from a multi-ethnic population (the Northern Manhattan Study). Willey, JZ., Moon, YP., Sacco, RL., 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]

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 single session of high-intensity interval training (HIT) on a treadmill was found to be feasible for stroke survivors, with participants able to walk at speeds significantly faster than their usual overground walking speed, indicating potential for improved rehabilitation outcomes.

No adverse events occurred during the training, and participants reached heart rates in the vigorous exercise range, suggesting that this HIT approach is safe and could enhance cardiovascular fitness in post-stroke rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of single session high-intensity interval training utilizing speed and active recovery to push beyond standard practice post-stroke. Aaron, SE., Gregory, CM.[2022]

High-intensity training shows promising benefits for stroke patients, but there is a lack of clear definitions and measurements of exercise intensity in the existing literature, which complicates the prescription of effective training protocols.

The review of 17 studies indicates that while high-intensity training can improve various outcomes like walking speed and cardiovascular fitness, the specific impacts on neurological and musculoskeletal systems remain unclear, highlighting the need for better assessment tools and outcome measures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What Is Intensity and How Can It Benefit Exercise Intervention in People With Stroke? A Rapid Review. Church, G., Smith, C., Ali, A., et al.[2023]

Eighteen randomized controlled trials were reviewed, revealing that interventions like aerobic and resistance training, electrical stimulation during walking, and robot-assisted arm therapy significantly increased physical activity in stroke patients.

Despite some effective interventions, the overall quality of evidence was low, and many studies showed no significant differences in physical activity, highlighting the need for more robust research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of interventions aimed at improving physical activity in individuals with stroke: a systematic review. Aguiar, LT., Nadeau, S., Martins, JC., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11984070/

High‐Intensity Gait Training for Patients After Stroke Mounting evidence suggests that gait training provided at high cardiovascular intensity with a focus on stepping practice improves gait function after stroke.

2. frontiersin.org frontiersin.org/journals/stroke/articles/10.3389/fstro.2025.1681632/full

High-Intensity Gait Training in Subacute Stroke Resulted ... High-Intensity Gait Training in Subacute Stroke Resulted in Increased Discharge Home from Inpatient Rehabilitation: A Quality Improvement Study.

3. mdpi.com mdpi.com/2077-0383/14/15/5409

Implementing High-Intensity Gait Training in Stroke ... Inpatient rehabilitation implementation studies have also demonstrated improvements in HIT result in substantial improvements in patient outcomes, although ...

4. 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.

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/abs/10.1002/pri.70059

High‐Intensity Gait Training for Patients After Stroke: A ... Mounting evidence suggests that gait training provided at high cardiovascular intensity with a focus on stepping practice improves gait function after stroke.

6. physio-pedia.com physio-pedia.com/Gait_Training_in_Stroke

Gait Training in Stroke Gait training with a person following a stroke is highly individualized. The below video shows an example of progressive intensive individualized gait training.

7. jneuroengrehab.biomedcentral.com jneuroengrehab.biomedcentral.com/articles/10.1186/s12984-025-01674-0

High-intensity interval training with robot-assisted gait therapy ... This study investigated the potential effectiveness of combining high-intensity interval training (HIIT) with robot-assisted gait therapy (RAGT) ...