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

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.

Study Overview

• Status: Completed
• Conditions: Persistent Concussion Symptoms
• Intervention / Treatment: Behavioral: Subthreshold exercise (STEP) with mobile health coaching; Behavioral: Light stretching (LS)

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98136
      • Seattle Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: STEP-mhc + 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.	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.
Active Comparator: LS alone; Subjects will be given a light stretching program alone (5 stretches). The exercise program will last for 6 weeks.	Behavioral: Light stretching (LS); Brief daily stretching routine.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Seattle Children's Hospital
• Investigators: Principal Investigator: Sara P Chrisman, MD MPH, Seattle Childrens Research Institute

Study record dates

Study Major Dates

• Study Start: April 1, 2016
• Primary Completion (Actual): September 1, 2017
• Study Completion (Actual): January 1, 2018

Study Registration Dates

• First Submitted: January 26, 2016
• First Submitted That Met QC Criteria: February 1, 2016
• First Posted (Estimate): February 3, 2016

Study Record Updates

• Last Update Posted (Actual): October 26, 2018
• Last Update Submitted That Met QC Criteria: October 24, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: Concussion; child; mild traumatic brain injury; post concussion syndrome
• Other Study ID Numbers: 00000023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO