Sport-related ConcussionNCT03575455
Sub-acute Exercise Following Sport-Related Concussion
A study testing Exercise in people with Sport-related Concussion, run by Florida State University at 1 site in United States.
Trial summary
Determine the safety and efficacy of sub-maximal aerobic exercise during the subacute phase of recovery following sport-related concussion. Read more about this study
- Who is it for?
- Ages 13 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Sport-related Concussion
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jan 2017to 1 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 13 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- high school student-athlete
- suffered a diagnosed concussion
- evaluated between Day 3 and Day 7 since injury
- high school student-athlete
- no diagnosed concussion within the last year
- matched with concussion participant for age and gender
Who cannot join
- physical limitation prohibiting treadmill walking
- reports dizziness or lightheadedness
- presents with any contraindication for exercise participation as defined by American College of Cardiology (ACC), American Heart Association (AHA), or American College of Sports Medicine (ACSM) guidelines.
Trial locations and contacts
1 site in 1 country.
United States1 site
Tallahassee Orthopedic Clinic
Tallahassee, Florida, 32308
About this study
Official title: The Short- And Long-Term Effects Of Submaximal Aerobic Exercise On Recovery Following Sport-Related Concussion In High School Student-Athletes
Determine the safety and efficacy of sub-maximal aerobic exercise during the subacute phase of recovery following sport-related concussion.
Read the detailed description
The main objective of the proposed study is to determine is exercise during the first 3-7 days following a sport-related concussion can help improve the systemic neurological dysfunction following a concussion while examining the safety and efficacy of a 20-minute, low- to moderate-intensity (40-60% of HRMAX) controlled treadmill aerobic exercise as a therapeutic modality to improve cardiovascular, psychological, vestibulo-ocular, autonomic, and cognitive function.
- Conditions
- Sport-related Concussion
- Being tested
- Exercise
- Keywords
- concussion, aerobic exercise, sub-acute
- Medical subject headings
- Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Also called Aerobic exercise
HR-controlled treadmill walking
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | Concussed participants will participate in a single 20' bout of treadmill walking at either 40% or 60% of the age-predicted HRmax.
Healthy participants will participate in a single 20' bout of treadmill walking at either 40% or 60% of the age-predicted HRmax. Receives: Behavioral: Exercise |
| Seated Control | No intervention | Concussed participants will participate in a single 20' treatment session of seated rest. Healthy participants will participate in a single 20' treatment session of seated rest. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Recovery
Clinical recovery is defined as the duration from the time of injury to the time a patient has received full clearance without restriction.
Measured: The number of days from injury to full medical clearance up to 365 days. 80% of adolescent athletes fully recover in less than 28 days.
Secondary outcomes (8)
Heart rate variability (HRV)
The RR Interval will be extracted from the heart rate monitoring system.
Measured: HRV will be captured for 10 minutes before, 20 minutes during, and after 25 minutes post "treatment".
Blood Pressure (SBP & DBP)
SBP \& DBP will be recorded with an automated auscultatory BP system
Measured: SBP & DBP will be captured for 10 minutes before, 20 minutes during, and after 25 minutes post "treatment".
Ocular Dysfunction
Improvements in ocular dysfunction will be defined as a decrease in errors or reading time
Measured: The King-Devick (K-D) will be administered before and within 5 minutes after the acute 20 minute "treatment"
Vestibular Dysfunction
Improvements in vestibular dysfunction will be defined as a decrease in symptom provocation or pretest symptom reporting
Measured: The Vestibular / Ocular Motor Screening (VOMS) will be administered before and within 5 minutes after the acute 20 minute "treatment"
Rating of Perceived Exertion (RPE)
Borg's CR-15 will be utilized to quantifying perceived intensity of exercise
Measured: RPE will be captured for 10 minutes before, 20 minutes during, and after 25 minutes post "treatment".
Concussion Symptoms
All 22 symptoms from the Post-concussion symptom scale (PCSS) as measured on a Likert scale from 0 (not present) to 6 (severe)
Measured: Symptoms will be captured for 10 minutes before, 20 minutes during, and after 25 minutes post "treatment".
Exercise Bout Completion Rates
The rate of completion will be defined as the ability for the participant to finish the "treatment" without early termination.
Measured: Completion will be determined and recorded at the end of the acute 20 minute treatment.
Incidence of Persistent Postconcussion symptoms >28 days
Persistent symptoms duration will be categorized as either ≤28 days or > 28 days.
Measured: The duration in days will be calculated from the day injury to the day full clearance up to 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2018
- Study start2 Jan 2017
- Primary completion1 Mar 2019
- Study completion1 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sport-related ConcussionStudies of the same condition, open and under way.
- More trials run by Florida State UniversityThe 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
- Model description
- Randomized block design using age and sex to randomize into 3 injured groups (40%, 60%, CON) and matching for 3 healthy groups (40%, 60%, CON)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida State University
- Sponsor type
- University, hospital or other
- Collaborators
- Tallahassee Orthopedic Clinic
- Responsible party
- Principal investigator, Phillip Worts, Florida State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03575455
- Sponsor's protocol ID
- RF02521 - TOC
- Status last verified
- Sep 2020
- First submitted
- 28 Mar 2018
- Last updated
- 16 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Worts PR, Mason JR, Burkhart SO, Sanchez-Gonzalez MA, Kim JS. The acute, systemic effects of aerobic exercise in recently concussed adolescent student-athletes: preliminary findings. Eur J Appl Physiol. 2022 Jun;122(6):1441-1457. doi: 10.1007/s00421-022-04932-4. Epub 2022 Mar 18.
PubMed 35303160
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Short- And Long-Term Effects Of Submaximal Aerobic Exercise On Recovery Following Sport-Related Concussion In High School Student-Athletes
- ClinicalTrials.gov ID
- NCT03575455
- Acronym / sponsor ID
- RF02521 - TOC
- Conditions
- Sport-related Concussion
- Keywords
- concussion, aerobic exercise, sub-acute
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Collaborators
- Tallahassee Orthopedic Clinic
- Study start
- 2 Jan 2017 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 1 Jul 2020 (actual)
- First posted
- 2 Jul 2018 (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.
Determine the safety and efficacy of sub-maximal aerobic exercise during the subacute phase of recovery following sport-related concussion.
Detailed description
The main objective of the proposed study is to determine is exercise during the first 3-7 days following a sport-related concussion can help improve the systemic neurological dysfunction following a concussion while examining the safety and efficacy of a 20-minute, low- to moderate-intensity (40-60% of HRMAX) controlled treadmill aerobic exercise as a therapeutic modality to improve cardiovascular, psychological, vestibulo-ocular, autonomic, and cognitive function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized block design using age and sex to randomize into 3 injured groups (40%, 60%, CON) and matching for 3 healthy groups (40%, 60%, CON)
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Behavioral: ExerciseConcussed participants will participate in a single 20' bout of treadmill walking at either 40% or 60% of the age-predicted HRmax. Healthy participants will participate in a single 20' bout of treadmill walking at either 40% or 60% of the age-predicted HRmax. |
| Seated Control | No intervention | –Concussed participants will participate in a single 20' treatment session of seated rest. Healthy participants will participate in a single 20' treatment session of seated rest. |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- high school student-athlete
- suffered a diagnosed concussion
- evaluated between Day 3 and Day 7 since injury
- high school student-athlete
- no diagnosed concussion within the last year
Key exclusion criteria (3 listed)
- physical limitation prohibiting treadmill walking
- reports dizziness or lightheadedness
- presents with any contraindication for exercise participation as defined by American College of Cardiology (ACC), American Heart Association (AHA), or American College of Sports Medicine (ACSM) guidelines.
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 |
|---|---|---|
| ExerciseAlso: Aerobic exerciseHR-controlled treadmill walking | Behavioural | Exercise |
Primary outcome
Clinical Recovery
Time frame: The number of days from injury to full medical clearance up to 365 days. 80% of adolescent athletes fully recover in less than 28 days.
Clinical recovery is defined as the duration from the time of injury to the time a patient has received full clearance without restriction.
8 secondary outcomes
Heart rate variability (HRV)
Time frame: HRV will be captured for 10 minutes before, 20 minutes during, and after 25 minutes post "treatment".
Blood Pressure (SBP & DBP)
Time frame: SBP & DBP will be captured for 10 minutes before, 20 minutes during, and after 25 minutes post "treatment".
Ocular Dysfunction
Time frame: The King-Devick (K-D) will be administered before and within 5 minutes after the acute 20 minute "treatment"
Vestibular Dysfunction
Time frame: The Vestibular / Ocular Motor Screening (VOMS) will be administered before and within 5 minutes after the acute 20 minute "treatment"
Rating of Perceived Exertion (RPE)
Time frame: RPE will be captured for 10 minutes before, 20 minutes during, and after 25 minutes post "treatment".
Concussion Symptoms
Time frame: Symptoms will be captured for 10 minutes before, 20 minutes during, and after 25 minutes post "treatment".
Exercise Bout Completion Rates
Time frame: Completion will be determined and recorded at the end of the acute 20 minute treatment.
Incidence of Persistent Postconcussion symptoms >28 days
Time frame: The duration in days will be calculated from the day injury to the day full clearance up to 1 year.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2020.
- Derived from this study: PubMed 35303160Worts PR, Mason JR, Burkhart SO, Sanchez-Gonzalez MA, Kim JS. The acute, systemic effects of aerobic exercise in recently concussed adolescent student-athletes: preliminary findings. Eur J Appl Physiol. 2022 Jun;122(6):1441-1457. doi: 10.1007/s00421-022-04932-4. Epub 2022 Mar 18.
- Individual participant dataSharing planned: No
Related trials for Sport-related Concussion
Recruiting
Ecological Test Standardization for Concussion Assessment in Football Players
Concussion, Brain, Sports-related Concussion
Recruiting
Pro-2-Cool Pivotal Trial II
Concussion, Mild
Not yet recruiting
Effect of Vestibular Rehabilitation on Gait, Balance, and Coordination in Post Concussion Combat Athletes
Concussion Post Syndrome, Concussion
RecruitingPhase 2
Naturally Produced Cannabinoids for Neuroprotection From Concussion
Healthy
Not yet recruiting
Mobile Dual-Task Brain and Balance Intervention for Concussion Recovery
Mild Traumatic Brain Injury (mTBI), Sports-related Concussion
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Sport-related Concussion, run by Florida State University 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 6 inclusion and 3 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: finished, as of the sponsor's last update on 16 Sep 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Recovery (time frame: The number of days from injury to full medical clearance up to 365 days. 80% of adolescent athletes fully recover in less than 28 days.). 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 NCT03575455, which also lists 1 linked publication.
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 16 Sep 2020.