Recruiting

Exercise

Sponsor:

University of Virginia

Code:

NCT06246669

Conditions

Concussion, Brain

Eligibility Criteria

Sex: All

Age: 18 - 25

Healthy Volunteers: Not accepted

Interventions

Treadmill Walking

Study Details

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.

Conditions

Concussion, Brain

Study ID

NCT06246669

Start date

Feb 27, 2024

Status verified date

Dec, 2024

Completion date

Mar, 2025

Anticipated

Primary completion date

Mar, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 25

Healthy Volunteers: Not accepted

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

Enrollment

46 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Moderate Intensity

Treadmill walking at a rating of perceived exertion (RPE) of 13.

experimental: Light Intensity

Treadmill walking at a rating of perceived exertion (RPE) of 9.

Interventions

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.

Primary outcome measure

  • 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. ]
  • 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. ]
  • 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. ]
  • 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. ]

Central Contacts and Locations

Central contacts

Jake Resch, PhD

434-243-6535jer6x@virginia.edu

Daniel Rosenblum, M.Ed.

203-253-4887dr6gz@virginia.edu

Locations

University of Virginia Department of Kinesiology

Recruiting

Charlottesville, Virginia, United States, 22903

Contacts

Jake Resch, PhD

434-243-6525jer6x@virginia.edu

Daniel Rosenblum, M.Ed.

dr6gz@virginia.edu

More Information

Sponsor

University of Virginia

Last update posted

Dec 9, 2024

Last verified

Dec, 2024

Keywords

  • kinesiophobia
  • exercise
  • anxiety

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Virginia on 2024-12-09.