NCT05434130 Modulating Exercise Dosage to Improve Concussion Recovery
| NCT ID | NCT05434130 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of Colorado, Denver |
| Condition | Concussion, Brain |
| Study Type | INTERVENTIONAL |
| Enrollment | 216 participants |
| Start Date | 2022-08-05 |
| Primary Completion | 2027-02-01 |
Trial Parameters
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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 14 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.
Eligibility 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)