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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-25
SponsorUniversity of Virginia

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Collegiate athlete (varsity)

Symptomatic at time of exercise prescription

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

46 Participants
are divided into 2 treatment groups
Group A: Moderate IntensityExperimental treatment 1 intervention
Group B: Light IntensityExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

A measure of fear beliefs associated with exercise, movement, and re-injury. Minimum score of 17, Maximum 68. Higher scores indicate worse kinesiophobia.

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.
2

Athlete Fear Avoidance Questionnaire (AFAQ)

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.

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.
3

Revised Head Injury Scale (HIS-r)

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.

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.
4

Days until symptom-free

The time it takes, in days, for a participant to report 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.

Secondary outcomes

1

Generalized Anxiety Index-7 (GAD-7)

Measure of anxiety levels over previous two weeks. Minimum score of 0 and maximum score of 21. Higher scores indicating higher levels of anxiety.

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.
2

Patient Health Questionnaire-9 (PHQ-9)

Measure of depression levels over previous two weeks. Minimum score of 0 and maximum score of 27. Higher scores indicate higher levels of depression.

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.
3

Days until return to sport

The time it takes, in days, for a participant to make a full return to their 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.
4

Step count

Number of steps taken during daily life outside of intervention.

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.

Other outcomes

Sponsors and contacts

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