The Influence of Prescribed Exercise on Pain Related Fear Following Concussion in Collegiate Athletes

Not Applicable

Recruiting

• Conditions: Concussion, Brain
• Interventions: Behavioral: Treadmill Walking

• Registration Number: NCT06246669
• Lead Sponsor: University of Virginia

Brief Summary

The goal of this clinical trial is to compare the effects of acute aerobic exercise at two different intensities on psychological measures, symptomology, and time to symptom free in collegiate student athletes with concussion. The main questions it aims to answer are:

* Does prescribed, acute aerobic exercise influence measures of pain related fear, anxiety, depression, symptoms, and recovery time?

* Does the intensity of the exercise prescription also influence the aforementioned outcomes?

Participants will be randomly assigned into either a light intensity or moderate intensity aerobic exercise (treadmill walking) group. They will initiate the exercise protocol 48 hours following their concussion diagnosis, and complete exercise sessions 5 times per week until they report symptom-free. Researchers will compare the light intensity group to the moderate intensity group to see if intensity of exercise influences psychological measures of pain related fear, anxiety, depression, symptomology, and time to symptom-free.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-01-20
• Study First Submitted QC: 2024-01-29
• Study First Posted: 2024-02-07
• Study Start: 2024-02-27
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-03
• Last Update Posted: 2024-12-09
• Primary Completion: 2025-03
• Study Completion: 2025-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

• Collegiate athlete (varsity)
• Symptomatic at time of exercise prescription

Exclusion Criteria

• If advanced neuroimaging was performed, any subject with a structural abnormality will be excluded
• History of traumatic brain injury requiring hospitalization
• Not cleared to play their sport by a physician due to some other injury such as an ankle sprain or muscle strain
• If individual is diagnosed with any condition that is a contraindication to aerobic exercise. Please note that all participants will have already been cleared to participate in their respective collegiate sport after extensive pre-participation physical examinations upon entering the university.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Light Intensity	Treadmill Walking	Treadmill walking at a rating of perceived exertion (RPE) of 9.
Moderate Intensity	Treadmill Walking	Treadmill walking at a rating of perceived exertion (RPE) of 13.

Primary Outcome Measures

Name	Time	Method
Athlete Fear Avoidance Questionnaire (AFAQ)	48 hours after concussion diagnosis and then every other day until participant reports symptom free which takes, on median, 6 days with a range of 0-203 days at the research site.	A measure of fear avoidance specifically designed for injured athletes. Minimum score of 10, Maximum score of 50. Higher scores indicate higher levels of fear-avoidance.
Revised Head Injury Scale (HIS-r)	48 hours after concussion diagnosis and then every single day until participant reports symptom free which takes, on median, 6 days with a range of 0-203 days at the research site.	A measure of 22 concussion related symptoms and their associated duration and severity over the previous 24 hours. Minimum duration of 1 and a maximum duration of 132. Minimum severity of 0 and maximum severity of 132. Higher levels of symptom count, duration, and severity indicate worse symptomology.
Days until symptom-free	Depends on individual injury characteristics but has a median of 6 days, range of 0-203 days at the research site.	The time it takes, in days, for a participant to report symptom free.
The Tampa Scale of Kinesiophobia-17 (TSK-17)	48 hours after concussion diagnosis and then every other day until participant reports symptom free which takes, on median, 6 days with a range of 0-203 days at the research site.	A measure of fear beliefs associated with exercise, movement, and re-injury. Minimum score of 17, Maximum 68. Higher scores indicate worse kinesiophobia.

Secondary Outcome Measures

Name	Time	Method
Generalized Anxiety Index-7 (GAD-7)	48 hours after concussion diagnosis and then every other day until participant reports symptom free which takes, on median, 6 days with a range of 0-203 days at the research site.	Measure of anxiety levels over previous two weeks. Minimum score of 0 and maximum score of 21. Higher scores indicating higher levels of anxiety.
Patient Health Questionnaire-9 (PHQ-9)	48 hours after concussion diagnosis and then every other day until participant reports symptom free which takes, on median, 6 days with a range of 0-203 days at the research site.	Measure of depression levels over previous two weeks. Minimum score of 0 and maximum score of 27. Higher scores indicate higher levels of depression.
Step count	Step count recording will begin 48 hours after concussion diagnosis and then every single day until participant reports symptom free which takes, on median, 6 days with a range of 0-203 days at the research site.	Number of steps taken during daily life outside of intervention.
Days until return to sport	Depends on individual injury characteristics but will be, on median, 5 days after reporting symptom free which takes 6 days on median at the research site.	The time it takes, in days, for a participant to make a full return to their sport.

Trial Locations

Locations (1)

University of Virginia Department of Kinesiology; 🇺🇸 Charlottesville, Virginia, United States