Acute Concussion Therapy Intervention Training in Healthy and Concussed Participants

Completed · Not applicable

Conditions studied: Cerebral Concussion

In brief

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.

Key facts

Study ID

NCT02872480

Run by

University of North Carolina, Chapel Hill

People needed

45

Starts

2016-08-01

Expected to finish

2017-02-01

Last updated by the study team

2017-02-17

Who can join

Age: 18 and older, up to 30. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.