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

Seattle Children's Healthcare System

Status: Completed

Conditions: Persistent Concussion Symptoms

Treatments: Behavioral: Light stretching (LS); Behavioral: Subthreshold exercise (STEP) with mobile health coaching

Study type: Interventional

Funder types: Other

Identifiers

NCT02673112

00000023

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 11 to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

30 participants in 2 patient groups

STEP-mhc + LS

Experimental group

Description:

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.

Treatment:

Behavioral: Light stretching (LS)

Behavioral: Subthreshold exercise (STEP) with mobile health coaching

LS alone

Active Comparator group

Description:

Subjects will be given a light stretching program alone (5 stretches). The exercise program will last for 6 weeks.

Treatment:

Behavioral: Light stretching (LS)