Clinical Trials Logo

Clinical 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. 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.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT02872480
Study type Interventional
Source University of North Carolina, Chapel Hill
Contact
Status Completed
Phase N/A
Start date August 2016
Completion date February 2017

See also
  Status Clinical Trial Phase
Completed NCT02858544 - Concussion in Motor Vehicle Accidents: The Concussion Identification Index N/A
Recruiting NCT04760834 - Concussion in French Amateur Rugby : Survey About the Management and Knowledge of Players
Completed NCT02776462 - Use of Eye Movement Tracking to Detect Oculomotor Abnormality in Traumatic Brain Injury Patients
Completed NCT01814527 - High Dose Omega-3 Fatty Acids in the Treatment of Sport Related Concussions N/A
Enrolling by invitation NCT05713942 - Concussion Assessments in Football
Enrolling by invitation NCT05542628 - Baseline Reference Values for Concussion Assessments in Football
Completed NCT02354469 - The Effects of Head Trauma on Collegiate Athletes
Recruiting NCT06365944 - Concussion in French Non-professional Handball League : Efficiency of a Concussion Protocol, the White Card Process