Concussion, BrainNCT06246669
The Influence of Prescribed Exercise on Pain Related Fear Following Concussion in Collegiate Athletes
A study testing Treadmill Walking in people with Concussion, Brain, run by University of Virginia at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Concussion, Brain
- What is being tested?
- Treadmill Walking
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Feb 2024to Mar 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Collegiate athlete (varsity)
- Symptomatic at time of exercise prescription
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Virginia Department of Kinesiology
Charlottesville, Virginia, 22903
Jake Resch, PhD, 434-243-6525, jer6x@virginia.edu
Daniel Rosenblum, M.Ed., dr6gz@virginia.edu
About this study
Official title: The Influence of Prescribed Exercise on Pain Related Fear Following Concussion in Collegiate Athletes: A Randomized Controlled 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.
- Conditions
- Concussion, Brain
- Being tested
- Treadmill Walking
- Keywords
- kinesiophobia, exercise, anxiety
- Medical subject headings
- Brain Concussion, Kinesiophobia, Motor Activity, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treadmill WalkingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Moderate Intensity | Experimental | Treadmill walking at a rating of perceived exertion (RPE) of 13. Receives: Behavioral: Treadmill Walking |
| Light Intensity | Experimental | Treadmill walking at a rating of perceived exertion (RPE) of 9. Receives: Behavioral: Treadmill Walking |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Depends on individual injury characteristics but has a median of 6 days, range of 0-203 days at the research site.
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2024
- Study start27 Feb 2024
- Primary completionMar 2025 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Concussion, BrainStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jacob Resch, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06246669
- Sponsor's protocol ID
- HSR230522
- Status last verified
- Dec 2024
- First submitted
- 20 Jan 2024
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data may be available upon reasonable request from qualified individuals.
Publications
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.
PubMed 37316185Lal 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.
PubMed 28570092Lawrence 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.
PubMed 29668716Thompson 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.
PubMed 36049743Reinking 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.
PubMed 34404602Jadhakhan 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.
PubMed 35589367Patricios 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.
PubMed 37316210
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Prescribed Exercise on Pain Related Fear Following Concussion in Collegiate Athletes: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06246669
- Acronym / sponsor ID
- HSR230522
- Conditions
- Concussion, Brain
- Keywords
- kinesiophobia, exercise, anxiety
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- 27 Feb 2024 (actual)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 7 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Moderate Intensity | Experimental | Behavioral: Treadmill WalkingTreadmill walking at a rating of perceived exertion (RPE) of 13. |
| Light Intensity | Experimental | Behavioral: Treadmill WalkingTreadmill walking at a rating of perceived exertion (RPE) of 9. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Collegiate athlete (varsity)
- Symptomatic at time of exercise prescription
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treadmill WalkingA 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. | Behavioural | Light Intensity, Moderate Intensity |
Primary outcome
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.
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.
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.
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.
4 secondary outcomes
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
- Background: PubMed 37316185Leddy 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.
- Background: PubMed 28570092Lal 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.
- Background: PubMed 29668716Lawrence 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.
- Background: PubMed 36049743Thompson 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.
- Background: PubMed 34404602Reinking 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.
- Background: PubMed 35589367Jadhakhan 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.
- Background: PubMed 37316210Patricios 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.
- Individual participant dataSharing planned: Yes. De-identified data may be available upon reasonable request from qualified individuals.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treadmill Walking in people with Concussion, Brain, run by University of Virginia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jake Resch, PhD (434-243-6535, jer6x@virginia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06246669, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2024.