Forced Aerobic Exercise for Stroke

Overseen By Sara Davidson, PTA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The Cleveland Clinic

Disqualifiers: Cardiac arrhythmia, Hypertrophic cardiomyopathy, others

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

Compensation: Varies

Number of Visits: 26

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how aerobic exercise (a type of cardiovascular exercise) can aid in recovering arm and leg movement after a stroke. Researchers aim to determine if adding aerobic exercise to repetitive arm tasks improves recovery and is cost-effective. Participants will either perform only arm exercises or a combination of cycling and arm exercises. This trial suits individuals who had a stroke at least 6 months ago, can walk 20 meters with some assistance, and have difficulty moving their affected arm. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance stroke recovery strategies.

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

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 prior data suggests that these rehabilitation interventions are safe for stroke recovery?

Research has shown that aerobic exercise is generally safe and beneficial for people recovering from a stroke. It can enhance heart health, walking ability, and overall quality of life. Experts often recommend aerobic exercise several times a week for stroke patients, indicating it is well-tolerated.

To improve arm strength and function after a stroke, practicing repetitive tasks with the upper body proves beneficial. Studies with many participants have demonstrated that this method enhances arm activity without major safety concerns.

Both aerobic exercise and repetitive task practice are popular in stroke recovery. Research strongly supports their safety and effectiveness. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the potential of combining aerobic exercise with repetitive task practice to improve recovery after a stroke. Unlike traditional rehabilitation methods, which often focus on repetitive exercises alone, this approach integrates cycling to enhance cardiovascular fitness alongside arm exercises. The idea is that aerobic exercise might boost brain plasticity and recovery by increasing blood flow and oxygen to the brain, potentially leading to better outcomes than standard care. By investigating this combined method, researchers hope to uncover a more effective way to help stroke survivors regain their motor skills.

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

Research has shown that aerobic exercise, one of the treatments in this trial, can significantly aid stroke recovery. It enhances physical fitness, helps regulate blood sugar levels, and promotes healthy blood flow. Additionally, it supports the brain's ability to form new connections and heal from damage, a process known as neuroplasticity. In this trial, some participants will engage in aerobic exercise combined with repetitive task practice. Studies indicate that exercises involving repetitive tasks improve arm strength and movement after a stroke. Participants often experience better movement following these exercises. Overall, both aerobic exercise and repetitive task practice, tested in separate arms of this trial, have shown promising results in helping stroke survivors regain function. ^{5 6 7 8 9}

Who Is on the Research Team?

Susan Linder, DPT

Principal Investigator

The Cleveland Clinic

Are You a Good Fit for This Trial?

This trial is for adults aged 18-85 who had a stroke at least 6 months ago, can walk over 20 meters with minimal help, and have moderate arm movement issues. It's not for those recently hospitalized for heart problems, arrhythmia, severe valve disease, lung clots or recent anti-spasticity treatments.

Inclusion Criteria

≥ 6 months following single ischemic or hemorrhagic stroke confirmed with neuroimaging,

Fugl-Meyer motor score 19-55 in the involved upper extremity,

Ambulatory ≥ 20 meters with no more than contact guard assistance, and

Exclusion Criteria

cardiac arrhythmia,

hypertrophic cardiomyopathy,

pulmonary embolus,

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline Assessment

Participants undergo an exercise stress test and baseline clinical assessments to quantify upper extremity function, gait, endurance, and self-reported quality of life

1 week

1 visit (in-person)

Treatment

Participants receive either 45 min of forced-rate aerobic exercise paired with 45 min of upper limb repetitive task practice or two back-to-back 45-minute sessions of upper limb repetitive task practice, 3 times per week for 8 weeks

8 weeks

24 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment with assessments at mid-treatment, end of treatment, and at 4 weeks, 6-months, and 12-months following end of treatment

12 months

Multiple visits (in-person and virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Aerobic Exercise
• Upper Extremity Repetitive Task Practice

Trial Overview The study tests if forced aerobic exercise helps stroke survivors recover arm and leg function better than standard therapy. It also assesses the cost-effectiveness of these exercises compared to repetitive task practice for upper extremities.

How Is the Trial Designed?

Group I: Upper Extremity Repetitive Task Practice Only Active Control 1 Intervention

Participants will perform the following: 1\. 90 minutes of upper extremity repetitive arm exercises

Group II: Aerobic Exercise & Repetitive Task Practice Active Control 2 Interventions

Participants will perform the following: 1. 45 minutes of cycling 2. 45 minutes of upper extremity repetitive arm exercises

Who Is Running the Clinical Trial?

The Cleveland Clinic

Lead Sponsor

Trials

1,072

Recruited

1,377,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3263535/

Physical Activity in the Prevention and Treatment of Stroke Aerobic training has been shown to enhance physical fitness and reduce cardiovascular risk factors in stroke patients who are generally less physically active ...

2. ahajournals.org ahajournals.org/doi/10.1161/str.0000000000000022

Physical Activity and Exercise Recommendations for ... An aerobic exercise program after stroke has been shown to enhance glucose regulation, improve blood pressure, and improve arterial function.

3. sciencedirect.com sciencedirect.com/science/article/pii/S1877065725000715

Cardiorespiratory exercise during rehabilitation is ... Cardiorespiratory exercise may aid stroke recovery by promoting neuroplasticity. · Planned cardiorespiratory exercise is associated with better functional ...

4. heart.org heart.org/en/news/2019/08/14/aerobic-exercise-could-improve-recovery-after-stroke

Aerobic exercise could improve recovery after stroke Overall, the exercise programs significantly improved stroke survivors' endurance level and walking speed. They were able to walk on average ...

5. bjsm.bmj.com bjsm.bmj.com/content/bjsports/58/7/392.full.pdf

Aerobic exercise interventions for promoting ... Objective To determine the superiority of aerobic exercise (AE) interventions on key outcomes of stroke recovery, including cardiorespiratory ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8204880/

Aerobic Exercise Recommendations to Optimize Best ... Aerobic exercise can help break this relentless cycle by improving aerobic capacity, walking ability, vascular health, and quality of life of stroke survivors.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11096558/

Mechanisms and benefits of cardiac rehabilitation in ... Current practice guidelines after stroke recommend structured aerobic exercise for at least 3–5 days per week, for a minimum of 20 min per ...

8. ahajournals.org ahajournals.org/doi/10.1161/CIRCRESAHA.125.325526

Epidemiology and Cardiovascular Benefits of Physical ... In this review, we focus on the beneficial effects of routine physical activity (PA) on the cardiovascular system, the different ways we can achieve and ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S1877065719301174

Effect of high-intensity exercise on cardiorespiratory fitness ... Our meta-analysis suggests that high-intensity exercise is beneficial for cardiorespiratory fitness in stroke survivors and might be safe as a novel ...