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Aerobic Training for Stroke

N/A
Recruiting
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
Stroke greater than 3 months ago
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 1 month
Awards & highlights

Study Summary

This trialcompares a cycling exercise program and an exergaming program in people with stroke, to see which is better for improving fitness, mobility, cognition, & self-efficacy.

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.Check my eligibility
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.See study design
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

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I had a stroke more than 3 months ago.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Average Gait Speed
Secondary outcome measures
Berg Balance Scale
Cognition
Timed up and GO
+1 more

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
~1310

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Who is running the clinical trial?

Columbia UniversityLead Sponsor
1,426 Previous Clinical Trials
2,473,760 Total Patients Enrolled
36 Trials studying Stroke
25,815 Patients Enrolled for Stroke
Scott BarbutoPrincipal InvestigatorColumbia University
Scott A. Barbuto, MDPrincipal InvestigatorColumbia University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the enrollment size of this investigation?

"Affirmative. According to clinicaltrials.gov, this research endeavour was initially posted on June 23rd of 2022 and is currently seeking participants; with an estimated 48 patients needed from a single site."

Answered by AI

Are there any vacancies in this medical experiment available to volunteers?

"Affirmative. In accordance with the latest data hosted on clinicaltrials.gov, this medical study is actively enlisting volunteers to participate in the trial. It was first posted on June 23rd 2022 and has been recently updated on November 4th of the same year; 48 individuals are required from a single site."

Answered by AI

Is eligibility for the study limited to persons under forty?

"This medical study is open to patients aged 18-65. Patients younger than 18 or older than 65 can look into 38 and 1006 other clinical trials respectively."

Answered by AI

What prerequisites must a person meet to be considered for inclusion in this experiment?

"This clinical trial is enrolling 48 individuals who have recently suffered a stroke and are aged 18 to 65. The primary criteria for application include an onset of the stroke over 3 months prior and an NIH Stroke Scale score lower than 15."

Answered by AI

What is the primary purpose of this research endeavor?

"The principal metric evaluated in this research project is Gait Speed, which will be measured at baseline and after a month. Furthermore, Berg Balance Scale (a 4-point evaluation of basic functional movements), VO2max (maximum oxygen consumption determined by breath measurement) and Timed up and GO (walking 10 feet at normal pace while timed by an examiner) are secondary objectives to be examined."

Answered by AI
~2 spots leftby May 2024