Recruiting
Phase 1
Phase 2

Exercise

Sponsor:

University of Colorado, Denver

Code:

NCT05434130

Conditions

Concussion, Brain

Treatment

Aerobic Exercise

Inflammation

Depression, Anxiety

Eligibility Criteria

Sex: All

Age: 13 - 18

Healthy Volunteers: Not accepted

Interventions

High Dose Exercise

Study Details

Brief summary:

Aerobic exercise has emerged as an effective treatment to reduce sport-related concussion symptom severity, yet existing work lacks rigor regarding the precise exercise volume and intensity required to elicit therapeutic effects, how exercise can alter concussion-related pathophysiology, and whether exercise can prevent the development of secondary sequelae. Our objective is to examine if a high dose exercise program (higher volume than currently prescribed at an individualized, safe intensity level) initiated within 21 days of concussion results in faster symptom resolution, altered physiological function, or reduced secondary sequalae. Findings from this research will lead to more rigorous and precise rehabilitation guidelines and improved understanding about how exercise affects neurophysiological function among adolescents with concussion.

Conditions

Concussion, Brain

Treatment

Aerobic Exercise

Inflammation

Depression, Anxiety

Study ID

NCT05434130

Start date

Aug 5, 2022

Status verified date

May, 2026

Completion date

Feb 1, 2027

Anticipated

Primary completion date

Feb 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 13 - 18

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 13-18 years of age
  • Post-Concussion Symptom Scale (PCSS) score >10 to ensure participants are not recovered by enrollment
  • Concussion diagnosis by a sports medicine physician

Exclusion Criteria:

  • Pre-existing neurological disorders
  • Exercise contraindications
  • Concussion <6 months before enrollment (excluding the current injury)

Study Design

Enrollment

178 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: High Dose Exercise

The investigators will provide exercise dose recommendations for initial visit until symptom resolution, and revise upon symptom resolution (to use for the subsequent 8 weeks). These include intensity (target HR) and volume (frequency/duration). Intensity is calculated as 90% of the HR at the end of the exercise test. The volume recommendation is 150 mins/week (\~30 min/day; 5 days/week). The mode of exercise is another consideration. This will be left to participant preference, so that the investigators do not exclude potential participants due to lack of access to specific exercise equipment.

no intervention: Standard-of-care

Participants are instructed to perform activity in line with physician recommendations. This consists of a general recommendation (no specific HR/volume) or symptom limited physical activity.

Interventions

High Dose Exercise

The investigators will initially test and randomize adolescents ages 13-18 years old ≤21 days post-concussion to high dose aerobic exercise (>150 min/week, individualized intensity level) or standard-of-care (symptom limited, self-guided physical activity), and re-test upon symptom resolution and 8-weeks post symptom resolution

Primary outcome measure

  • Time from injury to symptom resolution [ Time Frame: From time of injury until defined symptom resolution observed, about 30 days ]
  • Serum biomarker concentration: GFAP change [ Time Frame: Baseline, Visit 2 (scheduled after symptoms resolve, about 35 days post-baseline) ]
  • Anxiety and depression severity change [ Time Frame: Baseline, Visit 2 (scheduled after symptoms resolve, about 35 days post-baseline) ]

Central Contacts and Locations

Central contacts

David R Howell, PhD

7207771502ConcussionResearch@cuanschutz.edu

Kelsie Richardson, MS

7207771502ConcussionResearch@cuanschutz.edu

Locations

University of Colorado Denver

Recruiting

Aurora, Colorado, United States, 80045

Contacts

David R Howell, PhD

7207771502ConcussionResearch@cuanschutz.edu

Kelsie Richardson, MS

7207771502ConcussionResearch@cuanschutz.edu

Boston Children's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Principal Investigator:

William P Meehan III, MD

Spaulding Rehabilitation Hospital

Recruiting

Cambridge, Massachusetts, United States, 02138

Principal Investigator:

J Andrew Taylor, PhD

More Information

Sponsor

University of Colorado, Denver

Last update posted

Aug 31, 2026

Last verified

May, 2026

Keywords

  • intervention
  • mild traumatic brain injury

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2026-08-31.