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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

No Placebo-Only Group

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.

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.

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.

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, visit 2 (scheduled after symptoms resolve, about 35 days post-baseline)

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Anxiety

Glial Fibrillary Acidic Protein

Time from injury to symptom resolution

Secondary study objectives

Academic concerns change

Cerebral Angiography

Cerebral vasoreactivity change

+7 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 1Eligibility criteria met