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

24 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Scott A. Barbuto, MD

Principal Investigator

Columbia University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+