Aerobic Exercise for Stroke

Overseen By Brian Schibler

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Columbia University

Disqualifiers: Other neurological impairments, Medically unstable, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two exercise programs for individuals who have experienced a mild or moderate stroke. One group will use a stationary bike at home for aerobic exercise, while the other will engage in active video games using a Nintendo Wii for exergame training. The researchers aim to assess how these exercises improve fitness, movement, thinking skills, and confidence in exercising. Individuals who had a stroke more than three months ago and have a mild level of disability might be suitable candidates. As an unphased trial, this study provides a unique opportunity to contribute to understanding innovative rehabilitation methods post-stroke.

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. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these exercise programs are safe for stroke patients?

Research shows that both aerobic exercise and exergame training are generally safe for people recovering from a stroke. Studies have found that aerobic exercise greatly improves heart and lung fitness and overall health in stroke survivors. It is well-tolerated, enhancing heart health and walking ability without major safety concerns.

For exergame training, research suggests that systems like the Nintendo Wii are also safe and effective for stroke patients. Exergames help with balance and movement, and studies show they are enjoyable and practical for patients. Importantly, participants in these studies usually experienced few negative effects, making this a promising option for recovery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about exploring aerobic exercise and exergame training for stroke recovery because these approaches bring unique benefits compared to traditional therapies. Aerobic exercise through stationary biking allows tailored intensity levels based on an individual's heart rate, offering a personalized and progressive way to improve cardiovascular health and physical endurance. Exergame training, using systems like the Nintendo Wii, adds an engaging and interactive element to rehabilitation, which can enhance motivation and adherence to the exercise regimen. These innovative methods could offer more enjoyable and adaptable recovery options, potentially leading to better outcomes for stroke survivors.

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

Research has shown that aerobic exercise greatly benefits people recovering from a stroke. It improves heart health, lowers blood pressure, and boosts physical abilities. Aerobic exercise also helps control blood sugar and enhances arterial function. In this trial, participants will engage in aerobic training using a stationary exercise bike. Conversely, playing active video games, such as those on the Nintendo Wii, can aid stroke patients with balance, movement, and posture. This trial includes an exergame training arm where participants will use the Nintendo Wii system. Studies suggest that both aerobic exercise and these active video games aid stroke recovery by improving fitness and mobility. Both methods offer promising ways to support recovery after a stroke. ^{4 5 6 7 8}

Who Is on the Research Team?

Scott A. Barbuto, MD

Principal Investigator

Columbia University

Are You a Good Fit for This Trial?

This trial is for individuals who have had a mild to moderate stroke at least 3 months ago, with an NIH stroke scale score under 15. It's not suitable for those unable to exercise, with other neurological issues, medical instability, joint pain, or heart problems like failure or arrhythmias.

Inclusion Criteria

NIH stroke scale score less than 15

I had a stroke more than 3 months ago.

Exclusion Criteria

You are not in a stable medical condition.

I have heart failure or an irregular heartbeat.

I experience joint pain.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either aerobic training using a stationary exercise bike or exergame training using the Nintendo Wii system at home

4 weeks

Weekly contact via email or phone

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Aerobic Exercise
• Exergame Training

Trial Overview The study aims to compare two types of physical activity: home-based aerobic cycling and video game-like exercises (exergaming). Researchers want to see which one better improves fitness levels, mobility, cognitive function, and confidence in exercising after a stroke.

How Is the Trial Designed?

Group I: Aerobic Training Experimental Treatment 1 Intervention

Participants will be given a stationary exercise bike for home use. They will be instructed to use the exercise bike five times a week for thirty-minute sessions. The exercise intensity prescription will be based on the subject's maximum heart rate based on age. The exercise program will start at 60% of max heart rate, and then will be increased by steps of 5% intensity every 2 weeks until participants reach 30 minutes of training at 80% intensity. In addition, rate of perceived exertion (Borg scale) will be assessed at each training session. Participants will be contacted weekly by email or phone to answer any questions about the exercise protocol and will be instructed to log each training session. Subjects will record duration of exercise, perceived exertion, average heart rate, maximum heart rate, and distance. Subjects will be asked to use the bike for 1 month

Group II: Exergame Training Active Control 1 Intervention

The Nintendo wii system will be used as the rehabilitation exergame system in the study. Wii-fit games will be used and the subjects will be shown to system at the initial assessment. Participants will be instructed to play 30 minutes a day, 5 days per week for 1 month. Participants will be contacted weekly by email or phone to answer any questions about the exercise protocol and will be instructed to log each training session. Subjects will record duration of exercise, perceived exertion, balance challenge, and which games they played.

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+

Citations

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

Mechanisms and benefits of cardiac rehabilitation in ... Human and animal studies have demonstrated the mechanisms and benefits of aerobic exercise for both cardiovascular and neurovascular health.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3508075/

Aerobic Exercise in Subacute Stroke Improves ... Aerobic exercise in subacute stroke was beneficial for improving cardiovascular health, reducing cardiac risk and improving physical performance (6MWT).

3. frontiersin.org frontiersin.org/journals/cardiovascular-medicine/articles/10.3389/fcvm.2025.1457899/full

Current exercise-based rehabilitation impacts on ... Overall, current exercise-based rehabilitation programs significantly improve blood pressure and exercise capacity in patients with stroke at discharge.

4. 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 ...

5. 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.

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. 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 ...

8. 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 ...