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Behavioral Intervention

Aerobic Exercise for Concussion

N/A
Recruiting
Led By Jacob McPherson
Research Sponsored by State University of New York at Buffalo
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Aged 18-40
Be between 18 and 65 years old
Must not have
Pre-existing conditions or presence of polytrauma that prevent participation in active testing and/or rehabilitation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to week 6
Awards & highlights

Summary

This trial will test if an exercise program developed for sport-related concussions can also help injured workers with concussions.

Who is the study for?
This trial is for workers aged 18-40 who suffered a concussion at work within the last 3 weeks and are involved with the workers compensation program. It's not specified who can't join, but typically those with other serious health issues or conditions that might interfere with exercise would be excluded.
What is being tested?
The study is testing an aerobic exercise program designed for sports-related concussions to see if it also helps injured workers recover from work-related concussions. Participants will follow a targeted heart rate exercise regimen.
What are the potential side effects?
While specific side effects aren't listed, aerobic exercises may cause fatigue, muscle soreness, and in some cases could exacerbate symptoms temporarily if not done carefully following a concussion.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 40 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have conditions or injuries that stop me from taking part in physical tests or rehab.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 1, week 2, week 3, week 4, week 5, week 6
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 1, week 2, week 3, week 4, week 5, week 6 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Adherence to Target Heartrate Aerobic Exercise (THRAE) program as measured by counting the number and duration of exercise sessions completed.
Secondary study objectives
Change in Basic Psychological Needs Satisfaction and Frustration Scale (BPNSFS)
Change in Generalized Anxiety Disorder-7 (GAD-7)
Change in Patient Health Questionnaire-9 (PHQ-9)
+5 more
Other study objectives
Rate of adverse Events as assessed by questioning the participant

Trial Design

1Treatment groups
Experimental Treatment
Group I: Target Heartrate Aerobic Exercise (THRAE)Experimental Treatment1 Intervention
Participants will be asked to complete the Buffalo Concussion Treadmill Test (BCTT), a safe graded exercise test that is used to identify concussion-related exertion intolerance. Participants will wear a heart rate (HR) monitor for the collection of continuous HR data. The test is stopped when a participant's symptoms increase subjectively by an intensity of 3 points or more from the pre-exercise value on a scale from 0-10, or they report being physically exhausted. Their HR at the time of test termination constitutes the HR threshold (HRt). An individualized THRAE program will be prescribed based on 80% of the HRt on the BCTT. Participants will be given a Polar HR monitor to wear while performing their THRAE prescription, which will be performed at home for 20 minutes, 4-5 days per week, for 6 weeks or until medically cleared from their concussion.

Find a Location

Who is running the clinical trial?

National Center for Advancing Translational Sciences (NCATS)NIH
342 Previous Clinical Trials
410,428 Total Patients Enrolled
State University of New York at BuffaloLead Sponsor
264 Previous Clinical Trials
52,060 Total Patients Enrolled
Jacob McPhersonPrincipal InvestigatorSUNY Buffalo
~10 spots leftby Nov 2024
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