Sub-Threshold Exercise Treatment for Adolescents With Sports Related Concussion

NCT02710123 | Completed Results

• 2 other identifiers: 030-690120UL1TR001412
• Study Type: interventional
• Target: 113
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Injury; Concussion

Outcome Measures

Primary Outcomes (1)

• Time (in Days) to Recovery

  Time (in days) to recovery (Recovery is asymptomatic+able to exercise to exhaustion without symptom exacerbation+judged recovered by MD with structured physical exam.)

  2 to 180 days

Study Arms (2)

Aerobic Exercise

EXPERIMENTAL

Participants will receive an exercise prescription based on their heart rate threshold (HRT) for symptom exacerbation during the Buffalo Concussion Treadmill Test (BCTT). The script will ask the participant to exercise one a day for 20 minutes at 80% of HRT. Participants will wear a smart watch to monitor their frequency, actual time and HR during exercise. Treatment will continue until participant is fully recovered from their concussion. Intervention: Sub-Threshold exercise prescription

Other: Sub-Threshold exercise prescription

Stretching Exercise

PLACEBO COMPARATOR

Participants will receive a prescription for stretching exercises that they will be asked to do daily. Participants will wear a smart watch to monitor their frequency, actual time and HR during exercise. Treatment will continue until participant is fully recovered from their concussion. Intervention: Structured stretching exercise prescription.

Other: Structured stretching prescription

Interventions

Sub-Threshold exercise prescription OTHER

Participants will be given a prescription to exercise at 80% of their threshold HR for symptom exacerbation. HR Threshold will be monitored weekly and exercise level increased accordingly.

Aerobic Exercise

Structured stretching prescription OTHER

Participants will be given a prescription for daily stretching lasting approximately 20 minutes.

Stretching Exercise

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Adolescent with concussion injury from sports within first 10 days

You may not qualify if:

• 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

Sponsors & Collaborators

• University at Buffalo: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

University at Buffalo

Buffalo, New York, 14214, United States

Location

Related Publications (3)

• Castellana MC, Burnett GJ, Gasper A, Nazir MSZ, Leddy JJ, Master CL, Mannix RC, Meehan WP 3rd, Willer BS, Haider MN. Adolescents With a High Burden of New-Onset Mood Symptoms After Sport-Related Concussion Benefit From Prescribed Aerobic Exercise, a Secondary Analysis of 2 Randomized Controlled Trials. Clin J Sport Med. 2025 Jan 1;35(1):29-36. doi: 10.1097/JSM.0000000000001242. Epub 2024 Jul 9.

  PMID: 38980666 DERIVED

• 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.

  PMID: 31377190 DERIVED

• 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.

  PMID: 30715132 DERIVED

MeSH Terms

Conditions

Brain Injuries; Brain Concussion

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

Participants were not blinded to treatment; thus, intervention bias is possible. We think this unlikely, since all participants received an active intervention without being told which might be better, and they received equal attention from the investigators.We did not assess expectation of benefit (ie, perceived credibility of each intervention prior to initiation) to estimate the potential magnitude of expectancy bias.

Results Point of Contact

• Title: John Leddy MD
• Organization: SUNY Buffalo

leddy@buffalo.edu

7162043200

Study Officials

• John Leddy, MD

  University at Buffalo

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 11, 2016
• First Posted: March 16, 2016
• Study Start: September 1, 2015
• Primary Completion: May 31, 2018
• Study Completion: June 1, 2018
• Last Updated: October 15, 2025
• Results First Posted: October 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)