Acute Concussion Therapy Intervention Training in Healthy and Concussed Participants (ACTIVE)

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

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.

Study Overview

• Status: Completed
• Conditions: Cerebral Concussion
• Intervention / Treatment: Other: ACTIVE Training

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.

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina at Chapel Hill

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ACTIVE Training; 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; 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).
No Intervention: Control; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: American College of Sports Medicine
• Investigators: Principal Investigator: Elizabeth F Teel, M.S., University of North Carolina, Chapel Hill; Study Chair: Jason P Mihalik, Ph.D., University of North Carolina, Chapel Hill

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2016
• Primary Completion (Actual): February 1, 2017
• Study Completion (Actual): February 1, 2017

Study Registration Dates

• First Submitted: July 27, 2016
• First Submitted That Met QC Criteria: August 16, 2016
• First Posted (Estimate): August 19, 2016

Study Record Updates

• Last Update Posted (Actual): February 17, 2017
• Last Update Submitted That Met QC Criteria: February 15, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: Exercise; Concussion
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds, Nonpenetrating; Brain Injuries; Brain Injuries, Traumatic; Brain Concussion
• Other Study ID Numbers: 15-2387; 16-2829 (Other Grant/Funding Number: American College of Sports Medicine)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO