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High-Dose Exercise for Concussion Recovery (MEDIC Trial)

Phase 2
Recruiting
Led By David R Howell, PhD
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
13-18 years of age
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, visit 2 (scheduled after symptoms resolve, about 35 days post-baseline)
Awards & highlights

MEDIC Trial Summary

This trial is testing if a high-dose exercise program can help reduce concussion symptoms, improve physiological function, and prevent long-term effects.

Who is the study for?
This trial is for teens aged 13-18 who have been diagnosed with a concussion by a sports medicine physician and are still experiencing symptoms (PCSS score >10). It's not suitable for those with pre-existing neurological disorders, exercise contraindications, or another concussion in the last 6 months.Check my eligibility
What is being tested?
The study tests if starting a high dose of aerobic exercise within two weeks after getting a concussion can speed up symptom recovery, change physiological functions, or prevent issues like depression and anxiety that sometimes follow concussions.See study design
What are the potential side effects?
While specific side effects aren't listed, high doses of exercise could potentially lead to overexertion or exacerbation of symptoms. Participants will be monitored closely to ensure safety.

MEDIC Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 13 and 18 years old.

MEDIC Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, visit 2 (scheduled after symptoms resolve, about 35 days post-baseline)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, visit 2 (scheduled after symptoms resolve, about 35 days post-baseline) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Anxiety
Glial Fibrillary Acidic Protein
Time from injury to symptom resolution
Secondary outcome measures
Academic concerns change
Cerebral Angiography
Cerebral vasoreactivity change
+7 more

MEDIC Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: High Dose ExerciseExperimental Treatment1 Intervention
The investigators will provide exercise dose recommendations for initial visit until symptom resolution, and revise upon symptom resolution (to use for the subsequent 8 weeks). These include intensity (target HR) and volume (frequency/duration). Intensity is calculated as 90% of the HR at the end of the exercise test. The volume recommendation is 150 mins/week (~30 min/day; 5 days/week). The mode of exercise is another consideration. This will be left to participant preference, so that the investigators do not exclude potential participants due to lack of access to specific exercise equipment.
Group II: Standard-of-careActive Control1 Intervention
Participants are instructed to perform activity in line with physician recommendations. This consists of a general recommendation (no specific HR/volume) or symptom limited physical activity.

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor
1,752 Previous Clinical Trials
2,165,383 Total Patients Enrolled
Boston Children's HospitalOTHER
769 Previous Clinical Trials
5,580,313 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,978 Previous Clinical Trials
2,680,137 Total Patients Enrolled

Media Library

High Dose Exercise Clinical Trial Eligibility Overview. Trial Name: NCT05434130 — Phase 2
Concussion Research Study Groups: High Dose Exercise, Standard-of-care
Concussion Clinical Trial 2023: High Dose Exercise Highlights & Side Effects. Trial Name: NCT05434130 — Phase 2
High Dose Exercise 2023 Treatment Timeline for Medical Study. Trial Name: NCT05434130 — Phase 2
~121 spots leftby Oct 2026
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