Actively Recruiting
Modulating Exercise Dosage to Improve Concussion Recovery: A Randomized Clinical Trial
Led by University of Colorado, Denver · Updated on 2026-05-06
216
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Colorado, Denver
Lead Sponsor
B
Boston Children's Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating the effects of different amounts of aerobic exercise on recovery from concussion in adolescents aged 13 to 18 years. The study aims to determine if a higher volume of exercise, performed at a safe and individualized intensity within 14 days after concussion, leads to quicker symptom improvement, changes in brain function, or fewer long-term complications. This research will also explore how exercise influences inflammation and blood flow in the brain, contributing to better rehabilitation guidelines for concussion treatment. Participants will be randomly assigned to one of two groups: a high dose exercise group performing more than 150 minutes of aerobic exercise per week at a personalized intensity, or a standard-of-care group following symptom-limited, self-guided physical activity without specific exercise targets. Exercise mode is flexible based on participant preference. The study includes initial testing, symptom monitoring, and follow-up visits scheduled upon symptom resolution and again eight weeks later. Throughout the study, participants will undergo assessments including symptom tracking, blood tests for biomarkers related to brain injury and inflammation, and measurements of brain blood flow regulation. Researchers will continuously monitor exercise activity and evaluate psychological factors such as anxiety, depression, fear of movement, social relationships, and academic concerns. The overall participation period lasts about 30 days from injury to symptom resolution, with additional follow-up continuing for eight weeks post recovery.
CONDITIONS
Brief Title
Modulating Exercise Dosage to Improve Concussion Recovery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 13 to 18 years of age
- Post-Concussion Symptom Scale (PCSS) score greater than 10
- Concussion diagnosis by a sports medicine physician
You will not qualify if you...
- Pre-existing neurological disorders
- Medical reasons preventing exercise
- Concussion within 6 months before enrollment, excluding the current injury
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to about 30 days or until symptom resolution
Participants undergo a randomized treatment to either high dose aerobic exercise or standard-of-care symptom limited physical activity until symptom resolution.
Initial baseline visit and 1 visit upon symptom resolution
Duration - 8 weeks post symptom resolution
Participants are reassessed 8 weeks after symptom resolution to evaluate long-term outcomes and recovery.
1 follow-up visit
Trial Site Locations
Total: 3 locations
1
University of Colorado Denver
Aurora, Colorado, United States, 80045
Actively Recruiting
2
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
3
Spaulding Rehabilitation Hospital
Cambridge, Massachusetts, United States, 02138
Actively Recruiting
Research Team
D
David R Howell, PhD
K
Kelsie Richardson, MS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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