Acute Concussion Therapy Intervention Training in Healthy and Concussed Participants

Cerebral Concussion Clinical Trial

— ACTIVE  

Official title:

The Effect of ACTIVE Training in Improving Clinical Outcomes in Healthy and Acutely Concussed College-aged Participants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02872480
• Other study ID #: 15-2387
• Secondary ID: 16-2829
• Status: Completed
• Phase: N/A
• First received: July 27, 2016
• Last updated: February 15, 2017
• Start date: August 2016
• Est. completion date: February 2017

Study information

• Verified date: February 2017
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Concussion
• Cerebral Concussion

Intervention

Other:
• ACTIVE Training
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).

Locations

Country	Name	City	State
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	American College of Sports Medicine Foundation (ACSM)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average Days to Recovery	Average number of days from injury to recovery (recovery is defined as full clearance by physician)	Assessed every 24 hours from baseline to study termination for each participant (approximately 10-14 days)
Secondary	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)	Each participant will complete the SAC at baseline (first testing session) and recovery (full clearance by physician)- approximately 10-14 days apart
Secondary	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)	Each participant will complete the BESS at at baseline (first testing session) and recovery (full clearance by physician)- approximately 10-14 days apart
Secondary	Average Change in Cognition	CNS Composite Score (percentile of participant's overall achievement on a computerized neurocognitive test; higher percentiles indicate better performance)	Each participant will complete CNS at at baseline (first testing session) and recovery (full clearance by physician)- approximately 10-14 days apart
Secondary	Average Change in Near-Point Convergence	Near-point convergence distance (average distance- over three trials- of convergence during vision, higher scores indicate poorer convergence)	Each participant will complete the VOMS at at baseline (first testing session) and recovery (full clearance by physician)- approximately 10-14 days apart
Secondary	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	Healthy participants will complete the GSC at at baseline (first testing session) and recovery (full clearance by physician)- approximately 10-14 days apart