Improving concussion recovery with high dose exercise
Modulating Exercise Dosage to Improve Concussion Recovery: A Randomized Clinical Trial
This study is testing if a special exercise program can help teenagers recover faster from concussions and feel better sooner.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 216 (estimated) |
| Ages | 13 Years to 18 Years |
| Sex | All |
| Sponsor | University of Colorado, Denver Academic / other |
| Locations | 3 sites (Aurora, Colorado and 2 other locations) |
| Trial ID | NCT05434130 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of a high dose aerobic exercise program on adolescents recovering from concussions. Participants aged 13-18 with ongoing symptoms will engage in a tailored exercise regimen initiated within 14 days of their concussion. The goal is to determine if this increased exercise volume leads to faster symptom resolution, improved physiological function, and reduced long-term complications. The findings aim to refine rehabilitation guidelines and enhance understanding of exercise's impact on brain recovery.
Who should consider this trial
Good fit: Ideal candidates are adolescents aged 13-18 who have been diagnosed with a concussion and are experiencing ongoing symptoms.
Not a fit: Patients with pre-existing neurological disorders or those who have had a concussion within the last six months may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly accelerate recovery times and improve outcomes for adolescents suffering from concussions.
How similar studies have performed: Previous studies have shown promising results with exercise interventions for concussion recovery, but this specific approach is novel in its focus on high dose exercise.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Aurora, Colorado and 2 other locations
- University of Colorado Denver — Aurora, Colorado, United States (Recruiting)
- Boston Children's Hospital — Boston, Massachusetts, United States (Recruiting)
- Spaulding Rehabilitation Hospital — Cambridge, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: David R Howell, PhD — University of Colorado Denver | Anschutz
- Study coordinator: David R Howell, PhD
- Email: ConcussionResearch@cuanschutz.edu
- Phone: 7207771502
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.