An interventional study of Treadmill Walking in Concussion, Brain, sponsored by University of Virginia. Recruiting at 1 site in United States. Open to participants aged 18 Years to 25 Years. Per ClinicalTrials.gov, last updated 2024-12-09.
Sponsored by University of Virginia · Not applicable, Interventional, and Treatment
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:
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.
530 studies on the registry are indexed under Brain Concussion; 151 are open to participants now.
This study's planned enrollment of 46 is below the median of 64 across 364 interventional studies indexed under Brain Concussion.
Browse Brain Concussion studies →University of Virginia is the lead sponsor of 653 studies on the registry; 134 are open to participants now.
Of its 60 completed or terminated interventional studies of FDA-regulated products, 41 (68%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Treadmill walking at a rating of perceived exertion (RPE) of 13.
Behavioral: Treadmill Walking
Treadmill walking at a rating of perceived exertion (RPE) of 9.
Behavioral: Treadmill Walking
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.
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.
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.
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.
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.
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.
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.
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.
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.
Plan to share: Yes — De-identified data may be available upon reasonable request from qualified individuals.
Supporting information: Study protocol
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