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

Concussion, Brain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06246669
• Other study ID #: HSR230522
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 2024
• Est. completion date: March 2025

Study information

• Verified date: January 2024
• Source: University of Virginia
• Contact: Jake Resch, PhD
• Phone: 434-243-6535
• Email: jer6x[@]virginia.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 46
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 25 Years

Eligibility

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.

Related Conditions & MeSH terms

• Brain Concussion
• Concussion, Brain

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Virginia

References & Publications (7)

Jadhakhan F, Sobeih R, Falla D. Effects of exercise/physical activity on fear of movement in people with spine-related pain: protocol for a systematic review and meta-analysis. BMJ Open. 2022 May 19;12(5):e060264. doi: 10.1136/bmjopen-2021-060264. — View Citation

Lal A, Kolakowsky-Hayner SA, Ghajar J, Balamane M. The Effect of Physical Exercise After a Concussion: A Systematic Review and Meta-analysis. Am J Sports Med. 2018 Mar;46(3):743-752. doi: 10.1177/0363546517706137. Epub 2017 Jun 1. — View Citation

Lawrence DW, Richards D, Comper P, Hutchison MG. Earlier time to aerobic exercise is associated with faster recovery following acute sport concussion. PLoS One. 2018 Apr 18;13(4):e0196062. doi: 10.1371/journal.pone.0196062. eCollection 2018. — View Citation

Leddy JJ, Burma JS, Toomey CM, Hayden A, Davis GA, Babl FE, Gagnon I, Giza CC, Kurowski BG, Silverberg ND, Willer B, Ronksley PE, Schneider KJ. Rest and exercise early after sport-related concussion: a systematic review and meta-analysis. Br J Sports Med. 2023 Jun;57(12):762-770. doi: 10.1136/bjsports-2022-106676. — View Citation

Patricios JS, Schneider KJ, Dvorak J, Ahmed OH, Blauwet C, Cantu RC, Davis GA, Echemendia RJ, Makdissi M, McNamee M, Broglio S, Emery CA, Feddermann-Demont N, Fuller GW, Giza CC, Guskiewicz KM, Hainline B, Iverson GL, Kutcher JS, Leddy JJ, Maddocks D, Manley G, McCrea M, Purcell LK, Putukian M, Sato H, Tuominen MP, Turner M, Yeates KO, Herring SA, Meeuwisse W. Consensus statement on concussion in sport: the 6th International Conference on Concussion in Sport-Amsterdam, October 2022. Br J Sports Med. 2023 Jun;57(11):695-711. doi: 10.1136/bjsports-2023-106898. — View Citation

Reinking S, Seehusen CN, Walker GA, Wilson JC, Howell DR. Transitory kinesiophobia after sport-related concussion and its correlation with reaction time. J Sci Med Sport. 2022 Jan;25(1):20-24. doi: 10.1016/j.jsams.2021.07.010. Epub 2021 Jul 29. — View Citation

Thompson XD, Newman TM, Donahue CC, Erdman NK, Statuta SM, Resch JE. Kinesiophobia Is Related to Acute Musculoskeletal Injury Incidence Following Concussion. J Sport Rehabil. 2022 Sep 1;32(2):145-150. doi: 10.1123/jsr.2022-0134. Print 2023 Feb 1. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.
Primary	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.	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.
Primary	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.	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.
Primary	Days until symptom-free	The time it takes, in days, for a participant to report symptom free.	Depends on individual injury characteristics but has a median of 6 days, range of 0-203 days at the research site.
Secondary	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.	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.
Secondary	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.	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.
Secondary	Days until return to sport	The time it takes, in days, for a participant to make a full return to their 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.
Secondary	Step count	Number of steps taken during daily life outside of intervention.	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.