Acute Concussion Therapy Intervention Training in Healthy and Concussed Participants

NCT ID: NCT02872480

Last Updated: 2017-02-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2017-02-28

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.

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.

Conditions

Cerebral Concussion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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).

Group Type: EXPERIMENTAL

ACTIVE Training

Intervention Type: 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).

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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).

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

American College of Sports Medicine

OTHER

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elizabeth F Teel, M.S.

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Jason P Mihalik, Ph.D.

Role: STUDY_CHAIR

University of North Carolina, Chapel Hill

Locations

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 30562056 (View on PubMed)

Other Identifiers

16-2829

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

15-2387

Identifier Type: -

Identifier Source: org_study_id