Acute Concussion Therapy Intervention Training in Healthy and Concussed Participants

NCT02872480 | Completed

• 2 other identifiers: 15-238716-2829
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cerebral Concussion

Keywords

Concussion; Exercise

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Average Change in Mental Status

  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

  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

  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

  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

  Healthy participants will complete the GSC at at baseline (first testing session) and recovery (full clearance by physician)- approximately 10-14 days apart

Study Arms (2)

ACTIVE Training

EXPERIMENTAL

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

Control

NO INTERVENTION

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.

Interventions

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).

ACTIVE Training

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• American College of Sports Medicine: collaborator

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (1)

• 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.

  PMID: 30562056 DERIVED

MeSH Terms

Conditions

Brain Concussion; Motor Activity

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating; Behavior

Study Officials

• Elizabeth F Teel, M.S.

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

• Jason P Mihalik, Ph.D.

  University of North Carolina, Chapel Hill

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2016
• First Posted: August 19, 2016
• Study Start: August 1, 2016
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: February 17, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)