150 Participants Needed

High-Intensity Stepping Training for Stroke Recovery

(LRC Trial)

TG
CH
Overseen ByChris Henderson
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Indiana University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

The proposed research will characterize of the time course of neurological and locomotor recovery as well as development of compensatory strategies throughout sub-acute and chronic phases post stroke. In addition, we will also investigate the extent to which measures of recovery and compensation are malleable and can be altered with specific interventions in both the early and late stages post-stroke. Delineation of the time course of development and magnitude of patterns of recovery and compensation should result in alternative predictive "rules' regarding how patients early post-stroke could recovery functional and neurological function.

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 data supports the effectiveness of the treatment High-Intensity Stepping Training for Stroke Recovery?

Research shows that high-intensity stepping training during stroke rehabilitation significantly improves walking speed and balance compared to usual care. Patients taking more steps per day and engaging in higher intensity activities showed better recovery in walking and balance.12345

Is high-intensity exercise safe for stroke recovery?

Research shows that high-intensity exercise is generally safe for stroke patients, with no major adverse events reported in studies. Minor incidents were noted in one study, but overall, it appears to be a safe option for improving recovery.24678

How does high-intensity stepping training differ from other stroke recovery treatments?

High-intensity stepping training is unique because it focuses on task-specific stepping at higher cardiovascular intensities, which significantly improves walking and balance outcomes compared to usual care. This approach emphasizes a higher dose and intensity of exercise, leading to better recovery of locomotor function post-stroke.12359

Research Team

TG

Thomas G Hornby

Principal Investigator

Indiana University School of Medicine

Eligibility Criteria

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.
See 4 more

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

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

Treatment Details

Interventions

  • High-Intensity Training
Trial OverviewThis 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.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Phase 2Experimental Treatment1 Intervention
Observational evaluations for 1 month followed by 3-4 months of high-intensity training (HIT)
Group II: Phase 1Experimental Treatment1 Intervention
Observational evaluations for 6 months followed by 3-4 months of high-intensity training (HIT)

Find a Clinic Near You

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+

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.
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 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.
Implementation of High-Intensity Stepping Training During Inpatient Stroke Rehabilitation Improves Functional Outcomes.Moore, JL., Nordvik, JE., Erichsen, A., et al.[2021]
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.
Step Number and Aerobic Minute Exercise Prescription and Progression in Stroke: A Roadmap.Peters, S., Klassen, T., Schneeberg, A., et al.[2022]

References

Training parameters and longitudinal adaptations that most strongly mediate walking capacity gains from high-intensity interval training post-stroke. [2023]
Implementation of High-Intensity Stepping Training During Inpatient Stroke Rehabilitation Improves Functional Outcomes. [2021]
Step Number and Aerobic Minute Exercise Prescription and Progression in Stroke: A Roadmap. [2022]
Addition of high-intensity interval training to a moderate intensity continuous training cardiovascular rehabilitation program after ischemic cerebrovascular disease: A randomized controlled trial. [2023]
Revisiting dose and intensity of training: Opportunities to enhance recovery following stroke. [2022]
Evidence of High-Intensity Exercise on Lower Limb Functional Outcomes and Safety in Acute and Subacute Stroke Population: A Systematic Review. [2023]
Effect of Home-Based High-Intensity Interval Training in Patients With Lacunar Stroke: A Randomized Controlled Trial. [2023]
High-intensity training in patients with lacunar stroke: A one-year follow-up. [2023]
Effectiveness of High-Intensity Interval Training for Fitness and Mobility Post Stroke: A Systematic Review. [2020]