← Back to Search

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
1,738 Previous Clinical Trials
2,149,310 Total Patients Enrolled
Boston Children's HospitalOTHER
761 Previous Clinical Trials
5,579,514 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,965 Previous Clinical Trials
2,672,581 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the High Dose Exercise regimen gained authorization from the Food and Drug Administration?

"High Dose Exercise was judged to have a safety rating of 2, due to the fact that Phase 2 trials have established some level of security without any evidence on efficacy."

Answered by AI

Are there any opportunities for participation in this trial currently available?

"Data hosted on clinicaltrials.gov confirms that this particular medical trial is actively recruiting participants, having been initially posted in August of 2022 and last updated in October of the same year."

Answered by AI

What are the eligibility criteria for participating in this research project?

"Aspiring participants must be from ages 13 to 18 and have a history of treatment. Altogether, 216 patients are required for full enrolment in this trial."

Answered by AI

What is the fundamental purpose of this research effort?

"The primary aim of this medical investigation, which is to be assessed across Baseline and Visit 2 (35 days after the initial visit), will focus on measuring GFAP in serum biomarkers. Additional objectives include monitoring changes in VEGF levels through venipuncture at 3 separate visits, assessing kinesiophobia severity via the Tampa Scale of Kinesiophobia questionnaire, and evaluating interleukin-1 receptor antagonist concentrations using digital array technology."

Answered by AI

How many participants has this experiment recruited thus far?

"Affirmative. Clinicaltrials.gov documents that this clinical trial is actively enrolling participants; it was initially posted on August 5th, 2022 and most recently edited on October 3rd, 2022. A total of 216 patients are being sought from three different locations."

Answered by AI

Does this research accept those aged eighty-five and above as participants?

"As per the requirements of this medical trial, participants must be aged between 13 and 18."

Answered by AI

Who else is applying?

What state do they live in?
Florida
Texas
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What site did they apply to?
University of Colorado Denver
Recent research and studies
clinicaltrials.govStudy
Modulating Exercise Dosage to Improve Concussion Recovery
2022. "Modulating Exercise Dosage to Improve Concussion Recovery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05434130.
All > Concussion
~130 spots leftby Oct 2026
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top