N/A N=113 Randomized Treatment

Sub-Threshold Exercise Treatment for Adolescents With Sports Related Concussion

Brain Injury · Concussion

Bottom Line

View on ClinicalTrials.gov: NCT02710123 ↗

Enrolled (actual)

113

Serious AEs

0.0%

Results posted

Oct 2025

Primary outcome: Primary: Time (in Days) to Recovery — 13; 17 Days

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Sub-Threshold exercise prescription (Other); Structured stretching prescription (Other)
Age: Pediatric, Adult · 10+ yrs
Sex: All
Sponsor: University at Buffalo
Primary completion: May 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Time (in Days) to Recovery	13; 17	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02710123). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.