What is the mechanism of action of this treatment?

Aerobic exercise cycle ergometer programs improve cardiovascular and respiratory efficiency through sustained physical activity, which enhances blood flow, oxygen delivery, and overall cardiovascular health. This is crucial for stroke patients as it aids in recovery by improving mobility, reducing the risk of secondary cardiovascular events, and enhancing overall physical endurance. Exergaming programs engage patients in interactive video games that require physical movement, which not only improves physical functions such as balance and coordination but also stimulates cognitive functions through engaging and repetitive tasks. This dual approach is particularly beneficial for stroke patients as it addresses both physical and cognitive impairments, promoting a more comprehensive recovery.

What side effects are associated with this type of intervention?

Common treatments for stroke that involve physical activity, such as aerobic exercise and exergaming, can lead to muscle soreness, fatigue, and in rare cases, cardiovascular strain if not properly monitored. Exergaming may also pose a risk of falls or injury if balance is lost. These interventions require careful supervision to ensure patient safety, particularly for those with pre-existing conditions.

What prior FDA approvals exist?

The FDA has approved several treatments for stroke, primarily focusing on medications like tissue plasminogen activator (tPA) for acute ischemic stroke and antiplatelet agents for secondary prevention. However, for rehabilitation, there are no specific FDA-approved treatments that directly align with aerobic exercise cycle ergometer programs or exergaming programs. These rehabilitation strategies are generally recommended based on clinical guidelines and evidence supporting their benefits in improving cardiovascular fitness, mobility, and cognitive functions in stroke patients. Exercise-based rehabilitation, including both traditional aerobic exercise and innovative exergaming, is widely recognized for its role in enhancing recovery and quality of life post-stroke.

What other types of research exist?

Promising novel alternatives for stroke patients in 2024 include: 1) Virtual Reality (VR) Rehabilitation, which uses immersive environments to engage patients in physical and cognitive tasks; 2) Robotics-Assisted Therapy, which provides guided physical exercises with real-time feedback; and 3) Tele-rehabilitation Programs, which offer remote, supervised exercise sessions and cognitive training through digital platforms.

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Aerobic Exercise for Stroke

N/A

Waitlist Available

Led By Scott Barbuto

Research Sponsored by Columbia University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Heart failure or other heart arrythmias

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and 1 month

Awards & highlights

No Placebo-Only Group

Summary

This trial tests two exercise programs for stroke survivors: one using an exercise bike and the other using active video games. It aims to see which method better improves movement, heart health, and confidence in daily activities. Active video games have been used in stroke rehabilitation to improve balance, mobility, and motivation.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects from participating in this trial may include typical exercise-related risks such as muscle soreness or strain. Those with specific health conditions related to their heart or joints were excluded to minimize serious complications.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have heart failure or an irregular heartbeat.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and 1 month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and 1 month

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 1 month for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Average Gait Speed

Secondary study objectives

Berg Balance Scale

Cognition

Timed up and GO

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Aerobic TrainingExperimental Treatment1 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 TrainingActive Control1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Aerobic Exercise

2013

Completed Early Phase 1

~1350

0 / 1Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Aerobic exercise cycle ergometer programs improve cardiovascular and respiratory efficiency through sustained physical activity, which enhances blood flow, oxygen delivery, and overall cardiovascular health. This is crucial for stroke patients as it aids in recovery by improving mobility, reducing the risk of secondary cardiovascular events, and enhancing overall physical endurance. Exergaming programs engage patients in interactive video games that require physical movement, which not only improves physical functions such as balance and coordination but also stimulates cognitive functions through engaging and repetitive tasks. This dual approach is particularly beneficial for stroke patients as it addresses both physical and cognitive impairments, promoting a more comprehensive recovery.