Safety Study for Adolescents With Concussion

NCT ID: NCT02714192

Last Updated: 2016-03-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2015-03-31

Brief Summary

The purpose of the study was to determine if administration of an exercise stress test within the first ten days after a sports related concussion would delay or otherwise interfere with recovery.

Detailed Description

The purpose of the study was to determine if administration of an exercise stress test within the first ten days after a sports related concussion would delay or otherwise interfere with recovery. All participants were adolescents injured while playing sports. All concussions were confirmed by an experienced sports medicine physician before random assignment of the participant to receive the treadmill test to determine exercise intolerance or not.

Recovery was defined as (a) return to asymptomatic state; (b) ability to exercise to exhaustion without exacerbation of symptoms and (c) confirmation of recovery by a physician who is blinded to the assignment and to results of exercise testing. Symptoms were self reported on a daily basis using an online data record.

Regardless of recovery rate all participants were assessed at two weeks following their first clinic visit. At the second visit all subjects, regardless of group assignment were assessed on ImPACT, and the treadmill based exercise stress test. Individuals who were not recovered by the second visit were followed until recovered no matter how long that took.

Analysis of data examined recovery rates of the two groups of adolescents to determine whether use of a exercise stress test early after concussion caused any adverse events or interfered in any way with recovery.

Conditions

Brain Injury; Concussion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

BCTT

Participants received an standardized exercise stress test within 7 days of concussive injury. Stress test is stopped when participant experiences any exacerbation of symptoms. Heart rate at time of symptom exacerbation is referred to as the threshold heart rate (THR). Stress test is known as the Buffalo Concussion Treadmill Test.

Group Type: EXPERIMENTAL

Exercise stress test (BCTT)

Intervention Type: OTHER

Participants are assessed for exercise tolerance using a treadmill with gradually increasing angle to increase workload. Stress test is stopped when there is symptom exacerbation or when participant experiences voluntary exhaustion.

No BCTT

All participants in the no intervention arm did not get assessed using the BCTT until they had fully recovered or when they had their second clinic visit fourteen days after their first visit.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Exercise stress test (BCTT)

Participants are assessed for exercise tolerance using a treadmill with gradually increasing angle to increase workload. Stress test is stopped when there is symptom exacerbation or when participant experiences voluntary exhaustion.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Adolescents with sports related concussion that appear for their first clinic visit within 10 days of injury

Exclusion Criteria

• Evidence of focal neurologic deficit;
• inability to exercise due to orthopaedic injury;
• diabetes or known heart disease; increased cardiac risk; ADHD; depression; anxiety; history of moderate or severe brain injury; more than 3 prior concussions;
• inability to understand spoken English.

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University at Buffalo

OTHER

Sponsor Role: lead

Responsible Party

Barry Willer

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

John J Leddy, MD

Role: PRINCIPAL_INVESTIGATOR

University at Buffalo

Locations

University at Buffalo

Buffalo, New York, United States

Countries

United States

References

Willer BS, Haider MN, Bezherano I, Wilber CG, Mannix R, Kozlowski K, Leddy JJ. Comparison of Rest to Aerobic Exercise and Placebo-like Treatment of Acute Sport-Related Concussion in Male and Female Adolescents. Arch Phys Med Rehabil. 2019 Dec;100(12):2267-2275. doi: 10.1016/j.apmr.2019.07.003. Epub 2019 Aug 1.

Reference Type: DERIVED

PMID: 31377190 (View on PubMed)

Other Identifiers

030-387696

Identifier Type: -

Identifier Source: org_study_id