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Modulating Exercise Dosage to Improve Concussion Recovery

NCT05434130 · University of Colorado, Denver
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Official title
Modulating Exercise Dosage to Improve Concussion Recovery: a Randomized Clinical Trial
About this study
Concussions are defined as a mild form of traumatic brain injury that result in acute neurological dysfunction. Recent work suggests post-concussion aerobic exercise at an intensity level below symptom exacerbation is safe. Yet, clinical benefits from existing randomized controlled trials indicate substantial room for improvement. Also, there is currently an incomplete understanding of the neurophysiology underlying changes in response to exercise treatment. Identifying the precise exercise dose (volume/intensity) required to elicit a therapeutic response following concussion will lead to enhanced and more precise post-concussion rehabilitation strategies. Published and pilot data by the investigators indicate light post-concussion exercise was associated with faster symptom resolution time and less severe symptoms, yet this relied on self-reported data and observational designs. Furthermore, the investigators have identified that the optimal exercise volume to differentiate those with/without concussion symptoms after one month was \>160 minutes/week, which is higher than standard exercise volumes prescribed (\>100 minutes/week), and in line with existing recommendations for cardiovascular health (\>150 minutes/week). Beyond this, given the positive effects of regular moderate exercise to reduce inflammation (e.g., interleukin 6) and restore cerebrovascular regulation, these physiological functions represent viable and feasible rehabilitation targets. Thus, using a prospective randomized clinical trial design, the investigators aim to identify if high dose exercise \>(150 minutes/week at an individualized intensity level), relative to standard-of-care, results in: faster/slower symptom resolution, altered physiological function, or reduced secondary sequalae. Our multidisciplinary investigative team has expertise investigating concussion, exercise physiology, fluid biomarkers, cerebrovascular physiology, and psychosocial outcomes. Thus, the investigators will enroll, initially test, and randomize adolescents ages 13-18 years old ≤14 days post-concussion to high dose aerobic exercise or standard-of-care (symptom limited, self-guided physical activity), and reassess upon symptom resolution and 8-weeks post symptom resolution. The investigators will obtain cerebrovascular function and serum biomarker data at each visit, and quantify exercise, symptoms, and secondary sequalae continuously. First, The investigators aim to examine how the dose (intensity, duration, and frequency) of an aerobic exercise program initiated within 10 days of concussion affects time to symptom resolution, relative to standard-of-care, among adolescents. Second, the investigators aim to assess the mechanistic relationship between aerobic exercise, biomarkers of neuroinflammation, and cerebrovascular function. Third, the investigators aim to elucidate how high dose exercise after concussion affects persistent secondary sequalae development (anxiety, depression, kinesiophobia, peer relationships, academic concerns). By challenging the currently accepted, exercise recommendations for sport-related concussion, the investigators will break new ground toward improving rehabilitation strategies.
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)
Study design
Enrollment target: 216 participants
Allocation: randomized
Masking: double
Age groups: child, adult
Timeline
Starts: 2022-08-05
Estimated completion: 2027-02-01
Last updated: 2024-09-26
Interventions
Behavioral: High Dose Exercise
Primary outcomes
  • Time from injury to symptom resolution (From time of injury until defined symptom resolution observed, about 30 days)
  • Serum biomarker concentration: GFAP change (Baseline, Visit 2 (scheduled after symptoms resolve, about 35 days post-baseline))
  • Anxiety and depression severity change (Baseline, Visit 2 (scheduled after symptoms resolve, about 35 days post-baseline))
Sponsor
University of Colorado, Denver · other
With: Boston Children's Hospital, Spaulding Rehabilitation Hospital, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Contacts & investigators
ContactDavid R Howell, PhD · contact · ConcussionResearch@cuanschutz.edu · 7207771502
ContactKelsie Richardson, MS · contact · ConcussionResearch@cuanschutz.edu · 7207771502
InvestigatorDavid R Howell, PhD · principal_investigator, University of Colorado Denver | Anschutz
All locations (3)
University of Colorado DenverRecruiting
Aurora, Colorado, United States
Boston Children's HospitalRecruiting
Boston, Massachusetts, United States
Spaulding Rehabilitation HospitalRecruiting
Cambridge, Massachusetts, United States
Modulating Exercise Dosage to Improve Concussion Recovery · TrialPath