Exercise and Rehabilitation for Stroke

Recruiting in Palo Alto (17 mi)

Overseen by Ryan E Ross, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Recruiting

Sponsor: VA Office of Research and Development

Disqualifiers: Neurological disease, Orthopedic condition, Severe hypertension, Uncontrolled diabetes, others

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

Stroke is a leading cause of disability in the U.S. and many Veteran stroke survivors live with severe disability. Despite recent advances in rehabilitation treatments many stroke survivors have persistent physical and mental difficulties such as reduced physical and cognitive function and depression. Developing innovative treatments that address these problems is necessary to improve long-term outcomes for stroke survivors. Aerobic exercise (AEx) can improve physical and cognitive function, and reduce depression. Additionally, AEx may enhance physical rehabilitation by making the brain more receptive to, and consequently improving the response to an intervention. Therefore, combining AEx with physical rehabilitation has the potential to improve multiple aspects of stroke recovery. This study will examine the effect of combining AEx with physical rehabilitation on physical and mental function in stroke survivors. By gaining a better understanding of the effects of this combined intervention the investigators aim to advance the rehabilitative care of Veteran stroke survivors.

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 Aerobic exercise, Aerobic Exercise, AEx, Physical Activity, Exercise Therapy, Lower extremity stretching, Physical therapy stretching, Rehabilitation stretching for stroke?

Research shows that aerobic exercise can improve walking speed and endurance in people who have had a stroke, which suggests it can help with recovery and rehabilitation. ^{1 2 3 4 5}

Is exercise and rehabilitation safe for stroke patients?

Exercise and rehabilitation, including aerobic exercise, are generally considered safe for stroke patients when conducted in supervised environments. While there are concerns about cardiovascular risks, studies suggest that the benefits of exercise outweigh the risks, especially when participants are screened and monitored. ^{1 2 6 7 8}

How is aerobic exercise treatment unique for stroke rehabilitation?

Aerobic exercise is unique for stroke rehabilitation because it focuses on improving cardiovascular health and functional capacity, which are often compromised after a stroke. Unlike other treatments, it uses the FITT principle (frequency, intensity, time, type) to tailor exercise programs, and recent studies suggest that high-intensity interval training can help achieve higher heart rates, potentially leading to better recovery outcomes. ^{1 2 3 9 10}

Eligibility Criteria

This trial is for stroke survivors aged 50-90 who had a unilateral stroke at least 6 months ago, can communicate, and have moderate arm movement impairment. They must pass an exercise test and have some ability to move the affected arm. Excluded are those with certain medical conditions like severe heart issues, other neurological diseases, severe cognitive impairments or vision problems that affect reaching.

Inclusion Criteria

I have moderate difficulty moving my arm.

I am between 50 and 90 years old.

I can move at least 3 blocks in a minute with my affected arm.

Exclusion Criteria

I have pain in my weak arm that stops me from reaching out.

I have severe difficulty speaking or understanding speech.

Your UBACC score is less than 15.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 8 weeks of intervention sessions combining aerobic exercise with upper extremity rehabilitation

8 weeks

24 sessions (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Aerobic exercise (Behavioral Intervention)
• Lower extremity stretching (Behavioral Intervention)

Trial Overview The study tests if combining aerobic exercise (AEx) with physical rehabilitation improves physical and mental functions in stroke survivors. It explores whether AEx before rehab makes the brain more responsive to treatment, potentially enhancing recovery outcomes.

Participant Groups

Group I: Stretching (CON) + upper extremity rehabilitation Experimental Treatment 2 Interventions

Subjects will perform 15 minutes of lower extremity stretching. Following lower extremity stretching subjects will receive 200 repetitions of DDP.

Group II: Aerobic exercise (AEx) + upper extremity rehabilitation Experimental Treatment 2 Interventions

Subject will receive a total of 24 intervention sessions. In each session, subjects will perform 15 minutes of AEx followed by 200 repetitions of an upper extremity rehabilitation program.

Aerobic exercise is already approved in United States, European Union, Canada for the following indications:

🇺🇸 Approved in United States as Aerobic Exercise for:

• Rehabilitation after stroke
• Improvement of physical function
• Enhancement of cognitive function
• Reduction of depression

🇪🇺 Approved in European Union as Aerobic Exercise for:

• Cardiovascular rehabilitation
• Improvement of physical function
• Enhancement of cognitive function

🇨🇦 Approved in Canada as Aerobic Exercise for:

• Rehabilitation after stroke
• Improvement of physical function
• Enhancement of cognitive function

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Ralph H. Johnson VA Medical Center, Charleston, SC Charleston, SC

Who Is Running the Clinical Trial?

VA Office of Research and Development Lead Sponsor

References

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

Aerobic Exercise Prescription in Stroke Rehabilitation: A Web-Based Survey of US Physical Therapists. [2018] Best practice recommendations indicate that aerobic exercise (AEX) should be incorporated into stroke rehabilitation. However, this may be challenging in clinical settings. The purpose of this study was to assess physical therapist (PT) AEX prescription for patients with stroke, including AEX utilization, barriers to AEX prescription, dosing parameters, and safety considerations.

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

Adverse Events During Submaximal Aerobic Exercise Testing in People With Subacute Stroke: A Scoping Review. [2023] Concern for adverse cardiovascular events and limited guidance regarding how to conduct aerobic exercise (AEx) testing for individuals poststroke are key barriers to implementation by physical therapists in stroke rehabilitation. This study aimed to describe the nature and safety of submaximal AEx testing protocols for people with subacute stroke (PwSS) and the nature of comorbidity of PwSS who underwent submaximal AEx testing.

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

Utilization of aerobic exercise in adult neurological rehabilitation by physical therapists in Canada. [2022] Although aerobic exercise (AE) has been shown to improve aerobic capacity and reduce morbidity in neurological populations, its application is challenging. The purpose of this study was to survey Canadian physical therapists practicing in adult neurorehabilitation regarding the use of AE in clinical practice.

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

Aerobic Exercise After Left-Sided Stroke Improves Gait Speed and Endurance: A Prospective Cohort Study. [2021] The aim of the study was to investigate the effects of aerobic exercise on individuals who have had a stroke and showed baseline scores lower than the standard scores for the 6-min and 10-meter walk tests.

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

Correlations between aerobic exercise time during physiotherapy and characteristics of patients with subacute stroke: A pilot cross-sectional study. [2023] The amount of aerobic exercise time (AET) is an important factor for improving physical function in patients with stroke. However, there is a lack of evidence regarding the factors for AET during physiotherapy, particularly in stroke patients.

6. Canada pubmed.ncbi.nlm.nih.gov

Evidence-based risk assessment and recommendations for physical activity clearance: stroke and spinal cord injury. [2016] Physical activity (PA) has potential benefits after stroke or spinal cord injury (SCI), especially in improving efficiency and functional capacity in activities of daily living. Currently, many who could benefit from PA may be routinely excluded from participation because of myths related to functional capacity and the concern for harm. The purpose of this review was to evaluate the literature for reports of adverse events during exercise after stroke or SCI, and to provide recommendations regarding exercise participation in supervised and unsupervised environments. Studies were evaluated for quality, and the summary level and quality of evidence were evaluated using the AGREE rubric, modified to address the main outcome measure of adverse events. Levels of exercise stress were evaluated for aerobic activities, using an established rubric. Included in the current analysis were 32 studies for stroke and 4 for SCI. In aggregate, this yielded a total of 730 experimental participants with stroke and 143 with SCI. It should be noted that almost all studies were not designed to examine naturally occurring adverse events from PA. Significant contraindications to unsupervised exercise include manifestation of autonomic dysreflexia in SCI and cardiovascular comorbidity after stroke. There are clear benefits of exercise training on physiological outcomes in stroke and SCI, but the relation between outcomes and safety remains unclear. However, taken on balance, the risk-to-benefit ratio favors the recommendation of exercise. This recommendation is based on studies in which participants were almost universally screened for participation in supervised environments. Thus, the grading of evidence for finding adverse events to support this conclusion is inadequate.

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] To report the six-month safety analyses among patients enrolled in the "Physical Fitness Training in Subacute Stroke-PHYS-STROKE" trial and identify underlying risk factors associated with serious adverse events.

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

Determining Safe Participation in Aerobic Exercise Early After Stroke Through a Graded Submaximal Exercise Test. [2021] The benefits of aerobic exercise early after stroke are well known, but concerns about cardiovascular risk are a barrier to clinical implementation. Symptom-limited exercise testing with electrocardiography (ECG) is recommended but not always feasible. The purpose of this study was to determine the frequency of and corresponding exercise intensities at which ECG abnormalities occurred during submaximal exercise testing that would limit safe exercise prescription beyond those intensities.

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

Does aerobic exercise and the FITT principle fit into stroke recovery? [2018] Sedentary lifestyle after stroke is common which results in poor cardiovascular health. Aerobic exercise has the potential to reduce cardiovascular risk factors and improve functional capacity and quality of life in people after stroke. However, aerobic exercise is a therapeutic intervention that is underutilized by healthcare professionals after stroke. The purpose of this review paper is to provide information on exercise prescription using the FITT principle (frequency, intensity, time, type) for people after stroke and to guide healthcare professionals to incorporate aerobic exercise into the plan of care. This article discusses the current literature outlining the evidence base for incorporating aerobic exercise into stroke rehabilitation. Recently, high-intensity interval training has been used with people following stroke. Information is provided regarding the early but promising results for reaching higher target heart rates.

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

Factors Influencing the Efficacy of Aerobic Exercise for Improving Fitness and Walking Capacity After Stroke: A Meta-Analysis With Meta-Regression. [2018] To assess the influence of dosing parameters and patient characteristics on the efficacy of aerobic exercise (AEX) poststroke.