Feasibility of Aerobic Exercise for Recovery From Work-related Concussion

Not Applicable

Recruiting

• Conditions: Concussion, Brain
• Interventions: Behavioral: Target Heartrate Aerobic Exercise

• Registration Number: NCT06263179
• Lead Sponsor: State University of New York at Buffalo

Brief Summary

There is a lot of research on how to treat people with sport-related concussion. There has not been a lot of research on the treatment of injured workers with concussion. An exercise program has been developed for people with sport-related concussion. It is suspected that this program may be helpful for injured workers with concussion too. This study will test the effect of this exercise in injured workers with concussion.

Detailed Description

Participants who are diagnosed with a concussion and agree to participant in the study will complete a demographics form and other relevant questionnaires. They will then perform a graded exertion test (the Buffalo Concussion Treadmill Test \[BCTT\]) at the clinic, this takes approximately 15 minutes. Participants will then be prescribed the individualized THRAE based on the results from the BCTT and will be sent home with a commercial heart rate monitor. Participants will perform exercises at home on their free time 4-5 days per week. Participants will return to the clinic weekly to be re-examined by the study physician and obtain a new heart rate prescription for the first six weeks until clinical recovery or the intervention period ends (6-weeks).

Study Timeline

• Study First Submitted: 2024-01-29
• Study First Submitted QC: 2024-02-14
• Study First Posted: 2024-02-16
• Study Start: 2024-06-12
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-22
• Last Update Posted: 2024-11-25
• Primary Completion: 2025-06-30
• Study Completion: 2025-08-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Aged 18-40
• Received a concussion at work and are engaged with the workers compensation program
• Within 3 weeks of concussive injury

Exclusion Criteria

• 3-point or less difference between current and pre-injury symptoms as measured by the Post-Concussion Symptom Inventory (PCSI)
• Moderate or severe TBI
• Injury involving loss of consciousness for >30 minutes or post-traumatic amnesia > 24 hours
• Pre-existing conditions or presence of polytrauma that prevent participation in active testing and/or rehabilitation
• History of more than 3 diagnosed concussions
• Active substance abuse/dependence
• Report of injury mechanism occurring due to physical assault
• Unwillingness to perform intervention
• Limited English proficiency.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Target Heartrate Aerobic Exercise (THRAE)	Target Heartrate Aerobic Exercise	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.

Primary Outcome Measures

Name	Time	Method
Adherence to Target Heartrate Aerobic Exercise (THRAE) program as measured by counting the number and duration of exercise sessions completed.	Up to 6 weeks	Adherence to Target Heartrate Aerobic Exercise (THRAE) program as measured by counting exercise sessions completed.

Secondary Outcome Measures

Name	Time	Method
Primary Care Post Traumatic Stress Disorder (PTSD) Screen for DSM-5 (PC-PTSD-5)	Baseline	The Primary Care Post Traumatic Stress Disorder (PTSD) Screen for DSM-5 (PC-PTSD-5) is used to measure probable PTSD among participants. Scores range from 0-5. Higher scores indicate increased probability of PTSD.
Change in Patient-Reported Outcomes Measurement Information System Global Health-10 (PROMIS-10)	Baseline, up to week 6	The Patient-Reported Outcomes Measurement Information System Global Health-10 (PROMIS-10) is used to measure general healthcare-related quality of life, including global physical health and global mental health. Both global physical health and global mental health have raw scores ranging from 4-20. Higher scores reflect higher participant ratings for global physical and mental health. This measure will be used to assess change in global physical and mental health between the initial and final visits.
Time to return to work measured in days	Up to week 6	Time to return to work as measured by difference between date of injury and date the participant is medically cleared to return to work
Change in post-concussive symptom burden as measured by the Post-Concussion Symptom Scale	Baseline, week 1, week 2, week 3, week 4, week 5, week 6	The Post-Concussion Symptom Scale (PCSS) is a validated 22-item self-report symptom questionnaire. Scores range from 0-132 with greater scores indicating increased symptom burden.
Change in Patient Health Questionnaire-9 (PHQ-9)	Baseline, up to week 6	The Patient Health Questionnaire-9 (PHQ-9) is used for rating the severity of depression among participants. Scores range from 0-27. Higher scores indicate increased severity of depression.
Work Climate Questionnaire - 6-Item Version	Baseline	The Work Climate Questionnaire - 6-Item Version is used for assessing participants' perceptions regarding the degree of autonomy supportiveness of their work managers or employers. Scores range of 6-42. Higher scores indicate a greater degree of perceived autonomy supportiveness.
Change in Basic Psychological Needs Satisfaction and Frustration Scale (BPNSFS)	Baseline, up to week 6	The Basic Psychological Needs Satisfaction and Frustration Scale (BPNSFS) is used to assess participant satisfaction or frustration with the psychological needs for autonomy, competence, and relatedness. The scale involves 6 subscales, including autonomy satisfaction, autonomy frustration, relatedness satisfaction, relatedness frustration, competence satisfaction, and competence frustration. Each subscale has scores ranging from 4-20. Higher scores indicate higher participant perceptions of the psychological need satisfaction or frustration reflected in the subscale. This measure will be used to assess change in psychological needs satisfaction and psychological needs frustration between the initial and final visits.
Change in Generalized Anxiety Disorder-7 (GAD-7)	Baseline, up to week 6	The Generalized Anxiety Disorder-7 (GAD-7) is used to measure the severity of anxiety among participants. Scores range from 0-21. Higher scores indicate increased severity of anxiety.

Trial Locations

Locations (1)

UBMD Orthopaedics and Sports Medicine; 🇺🇸 Williamsville, New York, United States