Modulating Exercise Dosage to Improve Concussion Recovery: a Randomized Clinical Trial

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 13
Maximum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Colorado
University of Colorado Denver
RECRUITING
Aurora
Massachusetts
Boston Children's Hospital
RECRUITING
Boston
Spaulding Rehabilitation Hospital
RECRUITING
Cambridge
Contact Information
Primary
David R Howell, PhD
ConcussionResearch@cuanschutz.edu
7207771502
Backup
Kelsie Richardson, MS
ConcussionResearch@cuanschutz.edu
7207771502
Time Frame
Start Date: 2022-08-05
Estimated Completion Date: 2027-02-01
Participants
Target number of participants: 216
Treatments
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.
Authors
J Andrew Taylor
Related Therapeutic Areas
Sponsors
Collaborators: Boston Children's Hospital, Spaulding Rehabilitation Hospital, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Leads: University of Colorado, Denver

This content was sourced from clinicaltrials.gov