NCT02673112

Study of an Exercise Program (STEP) for Youth With Concussion

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Seattle Children's Hospital · Academic / Other
• Sex: All
• Age: 11 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

To compare the efficacy of a sub-threshold aerobic exercise intervention provided with mobile health coaching (STEP-mhc) and a light stretching program (LS) to LS alone for 11-18 yo youth with persistent concussion symptoms.

Detailed description

This is a minimal risk randomized controlled trial whose aim is to test the efficacy of an exercise intervention (STEP) for youth 11-18 yo with persistent concussive symptoms (1-6 months inclusive). The investigators are utilizing an active control (light stretching). The primary outcome will be concussion symptoms measured with the Health-Behavior Inventory (HBI) in the first month after randomization. Long-term efficacy will be examined using standardized measures of quality of life and function over 6 months, and potential mediators will be explored including brain derived neurotrophic factor (BDNF), fear-avoidance and physical fitness. Physical activity will be measured with accelerometry to evaluate fidelity.

Conditions

• Persistent Concussion Symptoms

Interventions

Type	Name	Description
BEHAVIORAL	Subthreshold exercise (STEP) with mobile health coaching	Aerobic exercise program performed below the HR threshold that causes symptoms and administered by an RA using mobile health coaching
BEHAVIORAL	Light stretching (LS)	Brief daily stretching routine.

Timeline

• Start date: 2016-04-01
• Primary completion: 2017-09-01
• Completion: 2018-01-01
• First posted: 2016-02-03
• Last updated: 2018-10-26

Locations

1 site across 1 country: United States