Exercise for Improved Walking After Stroke

Overseen By Darcy Reisman, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Delaware

Disqualifiers: Cerebellar stroke, Neurologic conditions, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

80 Participants Needed

Trial Summary

What is the purpose of this trial?

Subjects with chronic stroke (\> 6 months post-stroke) will learn a new walking pattern through distorted visual feedback. Retention of the pattern will be tested without visual feedback immediately after learning and 24 hours later. Subjects will be randomly assigned to the control group or the exercise group. The control group will simply complete the learning task. The exercise group will complete 5 minutes of exercise immediately following the first retention test to test for the effects of exercise on retention 24 hours later.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Exercise, Physical Activity, Workout, Fitness Training for improving walking after stroke?

Research shows that exercise, including aerobic and resistance training, can improve physical activity and walking ability in people who have had a stroke. These activities help increase strength and fitness, which are important for better walking and overall recovery. ^{1 2 3 4 5}

Is exercise safe for people after a stroke?

Research shows that exercise programs, including aerobic and resistance training, are generally safe for people after a stroke, with studies focusing on safety analyses to ensure no serious adverse events occur. ^{2 4 6 7 8}

How does exercise treatment differ from other treatments for improving walking after stroke?

Exercise treatment, including aerobic and resistance training, is unique because it focuses on improving physical activity and overall fitness, which can enhance walking ability and cardiovascular health after a stroke. Unlike some other treatments, exercise can be adapted to individual needs and can be performed in various settings, such as at home or in community programs, making it a flexible and accessible option for stroke rehabilitation. ^{4 6 9 10 11}

Research Team

Darcy Reisman, PhD

Principal Investigator

University of Delaware

Eligibility Criteria

This trial is for individuals aged 18-85 who have had a single, unilateral stroke more than 6 months ago and can walk unassisted. They must have a specific level of stroke severity, confirmed by MRI or CT scan, and normal heart rate and blood pressure. People with recent serious heart issues, walking-limiting pain, additional neurological conditions, or severe communication problems cannot join.

Inclusion Criteria

Your heart beats between 40 and 100 times per minute when you are at rest.

Your blood pressure should be within a certain range when measured at rest. It should not be too low or too high.

I had a stroke over 6 months ago, confirmed by an MRI or CT scan.

Exclusion Criteria

I couldn't walk outside my home before having a stroke.

I have not had a heart bypass or heart attack in the last 3 months.

I have pain in my muscles or bones that makes it hard to walk.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Learning and Retention Testing

Participants learn a new walking pattern through distorted visual feedback. Retention is tested immediately after learning and 24 hours later.

1 day

2 visits (in-person)

Exercise Intervention

Exercise group completes 5 minutes of high intensity exercise immediately following the first retention test.

5 minutes

Follow-up

Participants are monitored for retention of the walking pattern 24 hours after initial learning.

24 hours

1 visit (in-person)

Treatment Details

Interventions

• Exercise

Trial Overview The study examines how exercise affects the ability to retain a new walking pattern learned through visual feedback in chronic stroke survivors. Participants are divided into two groups: one does the learning task only (control), while the other performs exercises after learning to see if it helps memory retention after 24 hours.

Participant Groups

Group I: Exercise Experimental Treatment 1 Intervention

Subjects will complete learning of a new walking pattern through distorted visual feedback and retention will be tested immediately without visual feedback. This will be followed immediately by 5 minutes of high intensity exercise. Retention without visual feedback will them be tested again 24 hours later.

Group II: Control Active Control 1 Intervention

Subjects will complete learning of a new walking pattern through distorted visual feedback and retention will be tested immediately after and 24 hours later (without visual feedback).

Who Is Running the Clinical Trial?

University of Delaware

Lead Sponsor

Trials

167

Recruited

25,700+

Findings from Research

In a study of 52 stroke survivors, neither aerobic cycling nor resistance training alone significantly improved walking distance or gait velocity compared to sham exercises, indicating that these single-modality exercises may not effectively enhance walking ability.

However, resistance training did lead to a significant 17% improvement in stair climbing power and enhanced muscle strength, power, and endurance, suggesting that while walking ability may not improve directly, targeted strength training can still address underlying physical impairments years after a stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of effect of aerobic cycle training and progressive resistance training on walking ability after stroke: a randomized sham exercise-controlled study. Lee, MJ., Kilbreath, SL., Singh, MF., et al.[2016]

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 Activate Physical Activity for Stroke pilot trial will evaluate the safety and feasibility of a multidisciplinary intervention designed to promote physical activity in 32 stroke patients undergoing rehabilitation, focusing on those who can walk at least 50 meters with assistance.

The primary outcomes will assess the safety of the intervention through monitoring adverse events and its feasibility by tracking retention and completion rates, with physical activity levels measured using a triaxial accelerometer as a secondary outcome.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a multidisciplinary intervention to promote physical activity in patients with stroke undergoing rehabilitation: study protocol for the ActivePAS pilot randomised controlled trial. Kanai, M., Nozoe, M., Ohtsubo, T., et al.[2022]

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 systematic review of 11 randomized controlled trials (RCTs) on home physical activity interventions for post-stroke patients revealed poor reporting quality, with only a median of 7 out of 39 CONSORT items fully reported.

Most studies relied on adherence diaries to assess physical activity, but there was a lack of objective adherence measurement methods, highlighting the need for improved reporting standards and more accurate assessment techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing adherence to physical activity programs post-stroke at home: A systematic review of randomized controlled trials. Lu, R., Lloyd-Randolfi, D., Jones, H., et al.[2021]

Higher-intensity exercise (greater than 70% of heart rate reserve) is more effective in improving cardiorespiratory fitness in stroke survivors compared to lower-intensity exercise, based on a review of 9 trials with 279 participants.

While longer exercise programs generally improved walking capacity, the effects of other exercise dose components like frequency, time, and type were not clearly determined, indicating a need for more focused research in these areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What Is the Dose-Response Relationship Between Exercise and Cardiorespiratory Fitness After Stroke? A Systematic Review. Galloway, M., Marsden, DL., Callister, R., et al.[2019]

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]

A combined aerobic and resistance training program following American Stroke Association guidelines significantly improves mobility in stroke survivors, evidenced by increased walking speed and endurance in a meta-analysis of 499 participants.

The exercise program was found to be safe with high adherence rates and few reported adverse events, suggesting it can be effectively integrated into usual care for stroke rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise Programs Delivered According to Guidelines Improve Mobility in People With Stroke: A Systematic Review and Meta-analysis. Pogrebnoy, D., Dennett, A.[2020]

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]

Treadmill training with or without body weight support does not significantly improve the likelihood of independent walking in stroke patients compared to other physiotherapy interventions, based on a review of 44 trials with 2658 participants.

However, treadmill training does lead to significant improvements in walking speed and endurance, particularly in patients who are already able to walk, with some benefits in endurance lasting beyond the initial training period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treadmill training and body weight support for walking after stroke. Mehrholz, J., Pohl, M., Elsner, B.[2023]

Treadmill training, with or without body weight support, does not significantly improve the likelihood of independent walking in stroke patients compared to other physiotherapy interventions, based on a review of 56 trials with 3105 participants.

However, treadmill training does lead to modest improvements in walking speed and endurance, particularly in stroke patients who are already able to walk, suggesting it may be more beneficial for those with some walking ability rather than those who are completely dependent.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treadmill training and body weight support for walking after stroke. Mehrholz, J., Thomas, S., Elsner, B.[2023]

References

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

Comparison of effect of aerobic cycle training and progressive resistance training on walking ability after stroke: a randomized sham exercise-controlled study. [2016]

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

Physical fitness training for stroke patients. [2023]

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

Effects of a multidisciplinary intervention to promote physical activity in patients with stroke undergoing rehabilitation: study protocol for the ActivePAS pilot randomised controlled trial. [2022]

4. England pubmed.ncbi.nlm.nih.gov

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

5. England pubmed.ncbi.nlm.nih.gov

Assessing adherence to physical activity programs post-stroke at home: A systematic review of randomized controlled trials. [2021]

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

What Is the Dose-Response Relationship Between Exercise and Cardiorespiratory Fitness After Stroke? A Systematic Review. [2019]

7. 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]

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

Exercise Programs Delivered According to Guidelines Improve Mobility in People With Stroke: A Systematic Review and Meta-analysis. [2020]

9. Sweden pubmed.ncbi.nlm.nih.gov

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

10. England pubmed.ncbi.nlm.nih.gov

Treadmill training and body weight support for walking after stroke. [2023]

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

Treadmill training and body weight support for walking after stroke. [2023]