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NCT Number: NCT06246669

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

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.

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Key information

Conditions

Concussion, Brain Anxiety Disorders Behavior Brain Concussion Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Head Injuries, Closed Kinesiophobia Mental Disorders Motor Activity Nervous System Diseases Phobic Disorders Trauma, Nervous System Wounds and Injuries Wounds, Nonpenetrating

Age range

18 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Virginia Department of Kinesiology

Charlottesville, Virginia, 22903, United States

Location status: Recruiting

Location contact

Daniel Rosenblum, M.Ed.

CONTACT

[email protected]

Jake Resch, PhD

CONTACT

[email protected]

434-243-6525

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

treadmill walking

Behavioral

A treadmill will be used for participant to walk on. The frequency of exercise will be 5 times per week until they report symptom-free. The intensity will be determined via random group allocation (RPE of 13 or 9). The type of exercise is treadmill walking. The time of the intervention will depend on the the time it takes an individual to reach a specific caloric expenditure as a function of their weight and treadmill incline. This is based on the most recent American Congress of Sports Medicine's guidelines for estimating gross energy expenditure during common physical activities.

Primary outcomes

  1. The Tampa Scale of Kinesiophobia-17 (TSK-17)

    Time frame: 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.

  2. Athlete Fear Avoidance Questionnaire (AFAQ)

    Time frame: 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.

  3. Revised Head Injury Scale (HIS-r)

    Time frame: 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.

  4. Days until symptom-free

    Time frame: 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.

Secondary outcomes

  1. Generalized Anxiety Index-7 (GAD-7)

    Time frame: 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.

  2. Patient Health Questionnaire-9 (PHQ-9)

    Time frame: 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.

  3. Days until return to sport

    Time frame: 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.

  4. Step count

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Daniel Rosenblum, M.Ed.

CONTACT

[email protected]

203-253-4887

Jake Resch, PhD

CONTACT

[email protected]

434-243-6535

Sponsors and collaborators

Lead sponsor

University of Virginia

Other

Registry information

Official study title

The Influence of Prescribed Exercise on Pain Related Fear Following Concussion in Collegiate Athletes: A Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 7, 2024
Registry last updated
Dec 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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