Modulating Exercise Dosage to Improve Concussion Recovery

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT05434130
Phase
PHASE2
Status
Recruiting
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Conditions

  • Aerobic Exercise
  • Concussion, Brain
  • Depression, Anxiety
  • Inflammation
  • Treatment

Eligibility Criteria

Sex
ALL
Age
13 Years - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • High Dose Exercise — BEHAVIORAL
    The investigators will initially test and randomize adolescents ages 13-18 years old ≤14 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

Study Details

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 14 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.

Key Dates

Start date
Aug 5, 2022
Status verified
May 2026
Primary completion
Feb 1, 2027
Completion
Feb 1, 2027

Study Design

Enrollment
216 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: High Dose Exercise
    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.
  • No Intervention: Standard-of-care
    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.

Primary Outcome Measure

Time from injury to symptom resolution [ Time Frame: From time of injury until defined symptom resolution observed, about 30 days ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
University of Colorado DenverAuroraColorado80045
David R Howell, PhD
[email protected]
7207771502
Kelsie Richardson, MS
[email protected]
7207771502
Boston Children's HospitalBostonMassachusetts02115
Danielle Hunt, MS
William P Meehan III, MD (PRINCIPAL_INVESTIGATOR)
Spaulding Rehabilitation HospitalCambridgeMassachusetts02138
Andrew Taylor, PhD
J Andrew Taylor, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Aurora, CO

By research site
University of Colorado Denver· Aurora, COBoston Children's Hospital· Boston, MASpaulding Rehabilitation Hospital· Cambridge, MA

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