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

Trial Summary

What is the purpose of this trial?

The purpose of this pilot study is to investigate the potential role of training frequency on locomotor outcomes following high-intensity gait training and provision of a home walking program.

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 data supports the effectiveness of the treatment High-Intensity Gait Training for stroke patients?

Research shows that physical fitness training, including high-intensity treadmill training, can improve walking ability, physical activity, and cardiorespiratory fitness in stroke patients. Additionally, interventions like aerobic and resistance training have been found to enhance physical activity and functional recovery after a stroke. ^{1 2 3 4 5}

Is high-intensity training generally safe for humans?

Research on physical fitness training in stroke patients shows that it can be safe, but there are risks of serious adverse events, especially in high-risk individuals. It's important to balance promoting physical activity with minimizing risks, and medical clearance is recommended before starting such programs. ^{6 7 8 9 10}

How is physical activity coaching different from other treatments for stroke?

Physical activity coaching for stroke involves high-intensity interval training (HIT), which uses short bursts of intense exercise followed by rest periods. This approach is more effective than traditional aerobic exercise in improving fitness and recovery, making it a unique and promising option for stroke rehabilitation. ^{11 12 13 14 15}

Research Team

Thomas G Hornby, PhD

Principal Investigator

Indiana University

Eligibility Criteria

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

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

Weight < 350 pounds

My leg movement is severely limited.

Exclusion Criteria

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.

I am currently in a physical therapy program.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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 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 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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Efficacy of interventions aimed at improving physical activity in individuals with stroke: a systematic review. [2021]

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

High-intensity treadmill training and self-management for stroke patients undergoing rehabilitation: a feasibility study. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Physical fitness training for stroke patients. [2023]

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

Consumer-Based Physical Activity Monitor as a Practical Way to Measure Walking Intensity During Inpatient Stroke Rehabilitation. [2018]

5. Sweden pubmed.ncbi.nlm.nih.gov

[Adapted exercise important after stroke. Acute and long-term effects of different training programs]. [2017]

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

Physical Fitness Training in Patients with Subacute Stroke (PHYS-STROKE): Safety analyses of a randomized clinical trial. [2022]

7. United States 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. [2015]

8. England pubmed.ncbi.nlm.nih.gov

Adverse events in cardiovascular-related training programs in people with spinal cord injury: a systematic review. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Adverse events among high-risk participants in a home-based walking study: a descriptive study. [2022]

10. United States 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). [2018]

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

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

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

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

13. England 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. [2022]

14. Switzerland pubmed.ncbi.nlm.nih.gov

What Is Intensity and How Can It Benefit Exercise Intervention in People With Stroke? A Rapid Review. [2023]

15. England pubmed.ncbi.nlm.nih.gov

Effects of a high-intensity task-oriented training on gait performance early after stroke: a pilot study. [2022]