Actively Recruiting

Phase 2
Age: 13Years - 18Years
All Genders
ID05434130

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

Age: 13Years - 18Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

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

Follow-up

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

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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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