Clinical trial NCT02710123: Sub-Threshold Exercise Treatment for Adolescents With Sports Related Concussion
Official title: Sub-Threshold Exercise Treatment for Adolescents With Sports Related Concussion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Injury
Concussion
Lead sponsor: University at Buffalo
Sponsor class: OTHER
Collaborators: name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2016-03-16
Enrollment: 103
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Adolescents with concussion will be randomly assigned to a treatment group where they will receive sub-threshold exercise, or assigned to a placebo group where they will receive structured stretching exercises. Both groups will receive standard medical coverage with regular clinic visits. All participants will record symptoms daily on a dedicated web site. All participants will be evaluated at time 1 with (1) structured physical exam, and (2) structured exercise stress test which is terminated when there is symptom exacerbation. The primary outcome measure is time to recovery where recovery is defined as (1) asymptomatic for two consecutive days, and (2) ability to exercise to exhaustion without exacerbation of symptoms, and (3) confirmed by a physician based on a structured physical exam.

Detailed description: Adolescents with concussion will be randomly assigned to a treatment group where they will receive sub-threshold exercise, or assigned to a placebo group where they will receive structured stretching exercises. Both groups will receive standard medical coverage with regular clinic visits. All participants will record symptoms daily on a dedicated web site. All participants will be evaluated at time 1 with (1) structured physical exam, and (2) structured exercise stress test which is terminated when there is symptom exacerbation. The primary outcome measure is time to recovery where recovery is defined as (1) asymptomatic for two consecutive days, and (2) ability to exercise to exhaustion without exacerbation of symptoms, and (3) confirmed by a physician based on a structured physical exam.

Eligibility criteria: Inclusion Criteria:

* Adolescent with concussion injury from sports within first 10 days

Exclusion Criteria:

* Evidence of focal neurologic deficit; ADHD; history of moderate or severe TBI; greater than 3 prior concussions (or having history of long recovery from concussion, \>3 mths); inability to understand English

Primary outcomes:
measure: Time (in days) to recovery
timeFrame: 2 to 180 days
Secondary outcomes:
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: University at Buffalo
state: New York
Study officials:
affiliation: University at Buffalo
name: John Leddy, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Leddy JJ, Haider MN, Ellis MJ, Mannix R, Darling SR, Freitas MS, Suffoletto HN, Leiter J, Cordingley DM, Willer B. Early Subthreshold Aerobic Exercise for Sport-Related Concussion: A Randomized Clinical Trial. JAMA Pediatr. 2019 Apr 1;173(4):319-325. doi: 10.1001/jamapediatrics.2018.4397.