Aerobic Exercise for Concussion Recovery in Teens

This study is looking at how different amounts of aerobic exercise (exercise that gets your heart pumping, like running or swimming) can help teenagers recover from a concussion. Researchers want to see if a higher dose of exercise, more than what is usually recommended, can help symptoms go away faster. You might be able to join if you are 13 to 18 years old, have been diagnosed with a concussion by a sports medicine doctor, and your concussion symptoms are still present. The study will compare a "high dose" exercise program to standard care (self-guided physical activity). Success will be measured by how quickly symptoms resolve, changes in a blood marker (GFAP), and changes in anxiety and depression levels. The current status of this study is unclear, and it plans to enroll 216 participants.

Study design
This is an interventional study that plans to enroll 216 participants. Participants will be randomly assigned to either a high dose aerobic exercise group or a standard-of-care group.
What's involved
Participants will be tested and then re-tested after their symptoms resolve, which is expected to be around 35 days after the initial visit.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed until their symptoms resolve, which is estimated to be about 30 days from the time of injury.

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NCT05434130

Modulating Exercise Dosage to Improve Concussion Recovery

Recruiting
PHASE2Ages 13–18InterventionalTreatment
University of Colorado, Denver
~216 participants
Updated 2026-05-06 on ClinicalTrials.gov
What's tested:High Dose Exercise

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Time from injury to symptom resolution
Measured over From time of injury until defined symptom resolution observed, about 30 days
+2 more outcomes measured
Concussion, Brain
Treatment
Aerobic Exercise
Inflammation
Depression, Anxiety
3 sites across 2 states
Massachusetts2
Colorado1
  • David R Howell, PhD · PRINCIPAL_INVESTIGATOR · University of Colorado Denver | Anschutz

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Eligibility criteria

Inclusion

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

Pre-existing neurological disorders
Exercise contraindications
Concussion \<6 months before enrollment (excluding the current injury)
  • Time from injury to symptom resolutionFrom time of injury until defined symptom resolution observed, about 30 days

    The PCSS is a standard form that records the presence and severity of 22 concussion symptoms at the time of testing. Participants rate their concussion symptoms from 0-6 where 0 equates to "no symptoms," and 6 to "severe symptoms."

  • Serum biomarker concentration: GFAP changeBaseline, Visit 2 (scheduled after symptoms resolve, about 35 days post-baseline)

    Concentrations of GFAP will be simultaneously assayed along with other biomarkers using multi-plex digital array technology, which allows for single molecule immunoarrays while minimizing the amount of sample required

  • Anxiety and depression severity changeBaseline, Visit 2 (scheduled after symptoms resolve, about 35 days post-baseline)

    Participants will report anxiety using the Hospital Anxiety and Depression Scale (HADS).The HADS addresses questions related to depression and anxiety symptoms. Responses range from 0 to 3, where 3=experiencing symptoms a great deal of the time, on 14 questions. Seven items are specific to depression symptoms, and 7 to anxiety symptoms. For each sub-scale (HADS-anxiety and HADS-depression) scores range from 0 (no symptoms) to 21 (maximum symptom severity).