Modulating Exercise Dosage to Improve Concussion Recovery
NCT05434130 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 216
Last updated 2026-05-06
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.
Conditions
- Concussion, Brain
- Treatment
- Aerobic Exercise
- Inflammation
- Depression, Anxiety
Interventions
- BEHAVIORAL
-
High Dose Exercise
The investigators will initially test and randomize adolescents ages 13-18 years old ≤14 days post-concussion to high dose aerobic exercise (\>150 min/week, individualized intensity level) or standard-of-care (symptom limited, self-guided physical activity), and re-test upon symptom resolution and 8-weeks post symptom resolution
Sponsors & Collaborators
- collaborator OTHER
-
Spaulding Rehabilitation Hospital
collaborator OTHER -
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
collaborator NIH -
University of Colorado, Denver
lead OTHER
Principal Investigators
-
David R Howell, PhD · University of Colorado Denver | Anschutz
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 13 Years
- Max Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-08-05
- Primary Completion
- 2027-02-01
- Completion
- 2027-02-01
Countries
- United States
Study Locations
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