An interventional study of ACTIVE Training in Cerebral Concussion, sponsored by University of North Carolina, Chapel Hill. Completed at 1 site in United States. Open to participants aged 18 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-02-17.
Sponsored by University of North Carolina, Chapel Hill · Not applicable, Interventional, and Treatment
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.
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.
530 studies on the registry are indexed under Brain Concussion; 151 are open to participants now.
This study's enrollment of 45 is below the median of 64 across 364 interventional studies indexed under Brain Concussion.
Browse Brain Concussion studies →University of North Carolina, Chapel Hill is the lead sponsor of 1,340 studies on the registry; 133 are open to participants now.
Of its 155 completed or terminated interventional studies of FDA-regulated products, 136 (88%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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).
Other: ACTIVE Training
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.
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).
Average Days to Recovery
Average number of days from injury to recovery (recovery is defined as full clearance by physician)
Time frame: Assessed every 24 hours from baseline to study termination for each participant (approximately 10-14 days)
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)
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
BESS Total Score (Participants are given errors for positions of poor postural control; out of 60 points; higher scores are indicative of poorer performance)
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
CNS Composite Score (percentile of participant's overall achievement on a computerized neurocognitive test; higher percentiles indicate better performance)
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
Near-point convergence distance (average distance- over three trials- of convergence during vision, higher scores indicate poorer 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
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
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
Plan to share: No
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University of North Carolina, Chapel Hill