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Completed

NCT Number: NCT02872480

Acute Concussion Therapy Intervention Training in Healthy and Concussed 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.

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Key information

Conditions

Cerebral Concussion Behavior Brain Concussion Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Head Injuries, Closed Motor Activity Nervous System Diseases Trauma, Nervous System Wounds and Injuries Wounds, Nonpenetrating

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ACTIVE Training

Other

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).

Primary outcomes

  1. Average Days to Recovery

    Time frame: Assessed every 24 hours from baseline to study termination for each participant (approximately 10-14 days)

    Average number of days from injury to recovery (recovery is defined as full clearance by physician)

Secondary outcomes

  1. Average Change in Mental Status

    Time frame: Each participant will complete the SAC at baseline (first testing session) and recovery (full clearance by physician)- approximately 10-14 days apart

    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)

  2. Average Changed in Balance

    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

    BESS Total Score (Participants are given errors for positions of poor postural control; out of 60 points; higher scores are indicative of poorer performance)

  3. Average Change in Cognition

    Time frame: Each participant will complete CNS at at baseline (first testing session) and recovery (full clearance by physician)- approximately 10-14 days apart

    CNS Composite Score (percentile of participant's overall achievement on a computerized neurocognitive test; higher percentiles indicate better performance)

  4. Average Change in Near-Point 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

    Near-point convergence distance (average distance- over three trials- of convergence during vision, higher scores indicate poorer convergence)

  5. Average Change in Concussive 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

    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

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • American College of Sports Medicine

Registry information

Official study title

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

Acronym: ACTIVE

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Aug 19, 2016
Registry last updated
Feb 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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