Cerebral ConcussionACTIVENCT02872480
Acute Concussion Therapy Intervention Training in Healthy and Concussed Participants
A study testing ACTIVE Training in people with Cerebral Concussion, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
Healthy (non-injured) and concussed college-aged participants will complete two testing sessions that include (1) clinical symptom, balance, and cognitive evaluations and (2) a progressive exercise session to establish symptom exacerbation or maximal exercise capacity. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebral Concussion
- What is being tested?
- ACTIVE Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2016to Feb 2017
- 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 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Diagnosed as having a concussion by a physician within three days of study enrollment (concussed participants only)
- Glasgow Coma Scale >13 (concussed participants only)
- Participants must be active, which is defined as 30 or more minutes of moderate to vigorous physical activity 3 or more days per week. All healthy participants must met this definition and concussed participants should have met this definition prior to injury.
- Good cardiovascular health (subject to approval from study physician)
Who cannot join
- Recreational drug use over the course of study participation
- Associated injuries (broken bones, etc.) that would limit the ability to successfully complete ACTIVE training
- For healthy participants, no history of concussion within the last year
- For concussed participants, skull fracture or brain bleed at time of the injury
- UNC Varsity athletes
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
About this study
Official title: The Effect of ACTIVE Training in Improving Clinical Outcomes in Healthy and Acutely Concussed College-aged Participants
Healthy (non-injured) and concussed college-aged participants will complete two testing sessions that include (1) clinical symptom, balance, and cognitive evaluations and (2) a progressive exercise session to establish symptom exacerbation or maximal exercise capacity. Individuals randomized to the control group will receive no intervention between sessions, while individuals randomized to the intervention group will complete 30 minutes of stationary bike exercise at least 3 days/week.
Read the detailed description
Healthy and concussed participants will be randomized to ACTIVE training (intervention) or control (no intervention) groups. Participants, regardless of group assignment, will receive clinical symptom, balance, and cognitive evaluations as well as a progressive exercise assessment at study outset. Concussed participants will enroll into the study within three days of injury and study participation will termination following 24 consecutive hours with no reported concussive symptoms. Healthy participants will have arbitrary start dates and will terminate the study 10-14 days later to approximate the general length of concussion recovery and, therefore, make the time between session in the healthy and concussed cohorts as equivalent as possible. Participants in the intervention group will complete stationary cycle ergometer workouts for 30 mins at least 3 days per week between testing sessions. Healthy participants will complete six ACTIVE training sessions, while concussed participants will complete ACTIVE training at least three days per week until asymptomatic. Concussed control participants will follow physician guidelines for rest and activity, while healthy control participants will be asked to follow their typical routines for rest and activity. Participants will repeat the identical testing session assessments prior to study termination.
- Conditions
- Cerebral Concussion
- Being tested
- ACTIVE Training
- Keywords
- Concussion, Exercise
- Medical subject headings
- Brain Concussion, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACTIVE TrainingOther
Participants will be asked to complete aerobic exercise on a stationary bike during 30-minute sessions. Intensity will progress under a standard procedure for healthy participants (60-80% of VO2max) and as tolerated by concussed participants (starting at 60% of symptom exacerbation).
| Study group | Role | What they receive |
|---|---|---|
| ACTIVE Training | Experimental | Healthy participants will be progressed from 60-80% of their VO2max as determined by the progressive exercise test over the course of 6 30-minute training sessions. Concussed participants will begin 30-minute training sessions at 60% of the VO2 achieved at symptom exacerbation of the exercise test. Intensity will be progressed as tolerated by the participant and training sessions will continue until the participant is asymptomatic for 24 consecutive hours (total number of sessions variable based on clinical recovery). Receives: Other: ACTIVE Training |
| Control | No intervention | Healthy controls will be asked to follow their normal routine for rest and physical activity. Concussed controls will be asked to follow the guidance for rest and activity as prescribed by the physicians and athletic trainers overseeing their clinical care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Days to Recovery
Average number of days from injury to recovery (recovery is defined as full clearance by physician)
Measured: Assessed every 24 hours from baseline to study termination for each participant (approximately 10-14 days)
Secondary outcomes (5)
Average Change in Mental Status
SAC Total Score (Out of 30 possible points; combination of scores from orientation (5), immediate memory (15), concentration (5), and delayed memory (5) sections; higher scores are indicative of better results)
Measured: Each participant will complete the SAC at baseline (first testing session) and recovery (full clearance by physician)- approximately 10-14 days apart
Average Changed in Balance
BESS Total Score (Participants are given errors for positions of poor postural control; out of 60 points; higher scores are indicative of poorer performance)
Measured: Each participant will complete the BESS at at baseline (first testing session) and recovery (full clearance by physician)- approximately 10-14 days apart
Average Change in Cognition
CNS Composite Score (percentile of participant's overall achievement on a computerized neurocognitive test; higher percentiles indicate better performance)
Measured: Each participant will complete CNS at at baseline (first testing session) and recovery (full clearance by physician)- approximately 10-14 days apart
Average Change in Near-Point Convergence
Near-point convergence distance (average distance- over three trials- of convergence during vision, higher scores indicate poorer convergence)
Measured: Each participant will complete the VOMS at at baseline (first testing session) and recovery (full clearance by physician)- approximately 10-14 days apart
Average Change in Concussive Symptoms
GSC Total Score (incorporates presence and severity for a total score on 27-items, each item rated from 0 (not present) to 6 (severe); higher scores indicate worse symptoms
Measured: Healthy participants will complete the GSC at at baseline (first testing session) and recovery (full clearance by physician)- approximately 10-14 days apart
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2016 (estimated)
- Study startAug 2016
- Primary completionFeb 2017
- Study completionFeb 2017
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 Cerebral ConcussionStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe 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
- Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- American College of Sports Medicine
- Responsible party
- Sponsor
- Investigators
- Elizabeth F Teel, M.S., Principal investigator, University of North Carolina, Chapel HillJason P Mihalik, Ph.D., Study chair, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02872480
- Sponsor's protocol ID
- 15-2387
- Other IDs
- 16-2829
- Acronym
- ACTIVE
- Status last verified
- Feb 2017
- First submitted
- 27 Jul 2016
- Last updated
- 17 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Teel EF, Register-Mihalik JK, Appelbaum LG, Battaglini CL, Carneiro KA, Guskiewicz KM, Marshall SW, Mihalik JP. Randomized Controlled Trial Evaluating Aerobic Training and Common Sport-Related Concussion Outcomes in Healthy Participants. J Athl Train. 2018 Dec;53(12):1156-1165. doi: 10.4085/1062-6050-7-18. Epub 2018 Dec 18.
PubMed 30562056
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of ACTIVE Training in Improving Clinical Outcomes in Healthy and Acutely Concussed College-aged Participants
- ClinicalTrials.gov ID
- NCT02872480
- Acronym / sponsor ID
- ACTIVE / 15-2387
- Conditions
- Cerebral Concussion
- Keywords
- Concussion, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- American College of Sports Medicine
- Study start
- Aug 2016
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 19 Aug 2016 (estimated)
- 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.
Healthy (non-injured) and concussed college-aged participants will complete two testing sessions that include (1) clinical symptom, balance, and cognitive evaluations and (2) a progressive exercise session to establish symptom exacerbation or maximal exercise capacity. Individuals randomized to the control group will receive no intervention between sessions, while individuals randomized to the intervention group will complete 30 minutes of stationary bike exercise at least 3 days/week.
Detailed description
Healthy and concussed participants will be randomized to ACTIVE training (intervention) or control (no intervention) groups. Participants, regardless of group assignment, will receive clinical symptom, balance, and cognitive evaluations as well as a progressive exercise assessment at study outset. Concussed participants will enroll into the study within three days of injury and study participation will termination following 24 consecutive hours with no reported concussive symptoms. Healthy participants will have arbitrary start dates and will terminate the study 10-14 days later to approximate the general length of concussion recovery and, therefore, make the time between session in the healthy and concussed cohorts as equivalent as possible. Participants in the intervention group will complete stationary cycle ergometer workouts for 30 mins at least 3 days per week between testing sessions. Healthy participants will complete six ACTIVE training sessions, while concussed participants will complete ACTIVE training at least three days per week until asymptomatic. Concussed control participants will follow physician guidelines for rest and activity, while healthy control participants will be asked to follow their typical routines for rest and activity. Participants will repeat the identical testing session assessments prior to study termination.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACTIVE Training | Experimental | Other: ACTIVE TrainingHealthy participants will be progressed from 60-80% of their VO2max as determined by the progressive exercise test over the course of 6 30-minute training sessions. Concussed participants will begin 30-minute training sessions at 60% of the VO2 achieved at symptom exacerbation of the exercise test. Intensity will be progressed as tolerated by the participant and training sessions will continue until the participant is asymptomatic for 24 consecutive hours (total number of sessions variable based on clinical recovery). |
| Control | No intervention | –Healthy controls will be asked to follow their normal routine for rest and physical activity. Concussed controls will be asked to follow the guidance for rest and activity as prescribed by the physicians and athletic trainers overseeing their clinical care. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Diagnosed as having a concussion by a physician within three days of study enrollment (concussed participants only)
- Glasgow Coma Scale >13 (concussed participants only)
- Participants must be active, which is defined as 30 or more minutes of moderate to vigorous physical activity 3 or more days per week. All healthy participants must met this definition and concussed participants should have met this definition prior to injury.
- Good cardiovascular health (subject to approval from study physician)
Key exclusion criteria (5 listed)
- Recreational drug use over the course of study participation
- Associated injuries (broken bones, etc.) that would limit the ability to successfully complete ACTIVE training
- For healthy participants, no history of concussion within the last year
- For concussed participants, skull fracture or brain bleed at time of the injury
- UNC Varsity athletes
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 |
|---|---|---|
| ACTIVE TrainingParticipants will be asked to complete aerobic exercise on a stationary bike during 30-minute sessions. Intensity will progress under a standard procedure for healthy participants (60-80% of VO2max) and as tolerated by concussed participants (starting at 60% of symptom exacerbation). | Other | ACTIVE Training |
Primary outcome
Average Days to Recovery
Time frame: Assessed every 24 hours from baseline to study termination for each participant (approximately 10-14 days)
Average number of days from injury to recovery (recovery is defined as full clearance by physician)
5 secondary outcomes
Average Change in Mental Status
Time frame: Each participant will complete the SAC at baseline (first testing session) and recovery (full clearance by physician)- approximately 10-14 days apart
Average Changed in Balance
Time frame: Each participant will complete the BESS at at baseline (first testing session) and recovery (full clearance by physician)- approximately 10-14 days apart
Average Change in Cognition
Time frame: Each participant will complete CNS at at baseline (first testing session) and recovery (full clearance by physician)- approximately 10-14 days apart
Average Change in Near-Point Convergence
Time frame: Each participant will complete the VOMS at at baseline (first testing session) and recovery (full clearance by physician)- approximately 10-14 days apart
Average Change in Concussive Symptoms
Time frame: Healthy participants will complete the GSC at at baseline (first testing session) and recovery (full clearance by physician)- approximately 10-14 days apart
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 17 Feb 2017.
- Derived from this study: PubMed 30562056Teel EF, Register-Mihalik JK, Appelbaum LG, Battaglini CL, Carneiro KA, Guskiewicz KM, Marshall SW, Mihalik JP. Randomized Controlled Trial Evaluating Aerobic Training and Common Sport-Related Concussion Outcomes in Healthy Participants. J Athl Train. 2018 Dec;53(12):1156-1165. doi: 10.4085/1062-6050-7-18. Epub 2018 Dec 18.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Elizabeth F Teel, M.S. principal investigator
University of North Carolina, Chapel Hill
Jason P Mihalik, Ph.D. study chair
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACTIVE Training in people with Cerebral Concussion, run by University of North Carolina, Chapel Hill 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 4 inclusion and 5 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 17 Feb 2017. 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?
Average Days to Recovery (time frame: Assessed every 24 hours from baseline to study termination for each participant (approximately 10-14 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 NCT02872480, 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 17 Feb 2017.