Clinical trial NCT02872480: Acute Concussion Therapy Intervention Training in Healthy and Concussed Participants
Official title: The Effect of ACTIVE Training in Improving Clinical Outcomes in Healthy and Acutely Concussed College-aged Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Concussion
Keywords: Concussion
Exercise
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: American College of Sports Medicine
First posted: 2016-08-19
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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

Primary outcomes:
measure: Average Days to Recovery
timeFrame: Assessed every 24 hours from baseline to study termination for each participant (approximately 10-14 days)
Secondary outcomes:
measure: Average Change in Mental Status
timeFrame: Each participant will complete the SAC at baseline (first testing session) and recovery (full clearance by physician)- approximately 10-14 days apart
measure: Average Changed in Balance
timeFrame: Each participant will complete the BESS at at baseline (first testing session) and recovery (full clearance by physician)- approximately 10-14 days apart
measure: Average Change in Cognition
timeFrame: Each participant will complete CNS at at baseline (first testing session) and recovery (full clearance by physician)- approximately 10-14 days apart
measure: Average Change in Near-Point Convergence
timeFrame: Each participant will complete the VOMS at at baseline (first testing session) and recovery (full clearance by physician)- approximately 10-14 days apart
measure: Average Change in Concussive Symptoms
timeFrame: Healthy participants will complete the GSC at at baseline (first testing session) and recovery (full clearance by physician)- approximately 10-14 days apart
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Elizabeth F Teel, M.S.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of North Carolina, Chapel Hill
name: Jason P Mihalik, Ph.D.
role: STUDY_CHAIR
References:
citation: 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.