Modulating Exercise Dosage to Improve Concussion Recovery
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age13-18
SponsorUniversity of Colorado, Denver
About this trial
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 21 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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Pre-existing neurological disorders
Exercise contraindications
Concussion <6 months before enrollment (excluding the current injury)
Trial design
Design model
Parallel
Treatments tested in this trial
High Dose Exercise
BehavioralThe investigators will initially test and randomize adolescents ages 13-18 years old ≤21 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
Treatment groups
178 Participants
are divided into 2 treatment groupsGroup A: High Dose ExerciseExperimental treatment 1 intervention
Group B: Standard-of-careNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Time from injury to symptom resolution
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."
Time frame
From time of injury until defined symptom resolution observed, about 30 days2
Serum biomarker concentration: GFAP change
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
Time frame
Baseline, Visit 2 (scheduled after symptoms resolve, about 35 days post-baseline)3
Anxiety and depression severity change
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).
Time frame
Baseline, Visit 2 (scheduled after symptoms resolve, about 35 days post-baseline)Secondary outcomes
1
Serum biomarker concentration: IL-6 change
Concentrations of IL-6 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
Time frame
Baseline, Visit 2 (scheduled after symptoms resolve, about 35 days post-baseline)2
Serum biomarker concentration: TNF-alpha change
Concentrations of TNF-alpha 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
Time frame
Baseline, Visit 2 (scheduled after symptoms resolve, about 35 days post-baseline)3
Serum biomarker concentration: IL1-RA change
Concentrations of IL1-RA 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
Time frame
Baseline, Visit 2 (scheduled after symptoms resolve, about 35 days post-baseline)4
Serum biomarker concentration: VEGF change
Serum biomarkers will be obtained via venipuncture at the initial visit, after symptom resolution, and 8 weeks after symptom resolution.
Time frame
Baseline, Visit 2 (scheduled after symptoms resolve, about 35 days post-baseline)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Colorado, Denver
Lead sponsor
Boston Children's Hospital
Collaborator
Spaulding Rehabilitation Hospital
Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Source ClinicalTrials.gov