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

Not Applicable

Completed

• Conditions: Persistent Concussion Symptoms
• Interventions: Behavioral: Subthreshold exercise (STEP) with mobile health coaching; Behavioral: Light stretching (LS)

• Registration Number: NCT02673112
• Lead Sponsor: Seattle Children's Hospital

Brief 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.

Study Timeline

• Study First Submitted: 2016-01-26
• Study First Submitted QC: 2016-02-01
• Study First Posted: 2016-02-03
• Study Start: 2016-04
• Primary Completion: 2017-09
• Study Completion: 2018-01
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-24
• Last Update Posted: 2018-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Sports-related concussion that occurred 1-6 months inclusive prior to the start of the study, and was diagnosed by a clinician trained in concussion management consistent with the Zurich definition of concussion ("a complex pathophysiological process affecting the brain, induced by biomechanical forces [that] results in a graded set of clinical symptoms that may or may not involve loss of consciousness")
• Persistent symptoms as defined by the presence of at least 2 concussive symptoms (from the Health Behavior Inventory, or HBI) at the time of recruitment which were not present prior to injury
• 11 to 18 years of age (inclusive) at time of recruitment

Exclusion Criteria

• Non-English speaking youth or parents
• Unwilling or unable to travel to Seattle Children's Hospital or Seattle Children's Research Institute twice during the course of the study
• Cervical spine or vestibular issues requiring further targeted intervention
• Other injuries or medical conditions in addition to concussion which would preclude vigorous exercise
• Psychiatric hospitalization in the year prior to enrollment
• Significant cognitive deficits such as mental retardation or autism
• Lack of worsening of concussive symptoms with exertion
• Significant abnormalities on routine brain imaging.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
STEP-mhc + LS	Subthreshold exercise (STEP) with mobile health coaching	Subjects will be asked to perform exercise at 80% of the heart rate threshold determined using the Balke protocol for 5 minutes greater than their measured minutes of MVPA/day at baseline (Subthreshold exercise program). They will also be given a light stretching protocol (5 stretches). The exercise intervention will last for 6 weeks and will be supported by weekly health coaching.
STEP-mhc + LS	Light stretching (LS)	Subjects will be asked to perform exercise at 80% of the heart rate threshold determined using the Balke protocol for 5 minutes greater than their measured minutes of MVPA/day at baseline (Subthreshold exercise program). They will also be given a light stretching protocol (5 stretches). The exercise intervention will last for 6 weeks and will be supported by weekly health coaching.
LS alone	Light stretching (LS)	Subjects will be given a light stretching program alone (5 stretches). The exercise program will last for 6 weeks.

Primary Outcome Measures

Name	Time	Method
Health Behavior Inventory (HBI)	Baseline, Weekly from 1-6 weeks, 3 months, 6 months	Measure change in concussion symptoms from the baseline evaluation to post-intervention (6 weeks) using HBI.

Secondary Outcome Measures

Name	Time	Method
PedsQL	Baseline, 6 weeks, 3 and 6 months	Health related quality of life
Fear of Pain Questionniare (FOPQ), child and parent	Trajectory from baseline, 6 weeks, 3 months, 6 months	Measure of fear avoidance
Moderate-vigorous physical activity (MVPA)	Baseline and 6 weeks	Hip-mounted research grade accelerometry

Trial Locations

Locations (1)

Seattle Children's Hospital; 🇺🇸 Seattle, Washington, United States