Clinical trial NCT02673112: Study of an Exercise Program (STEP) for Youth With Concussion
Official title: Study of an Exercise Program (STEP) for Youth With Concussion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Persistent Concussion Symptoms
Keywords: Concussion
mild traumatic brain injury
post concussion syndrome
child
Lead sponsor: Seattle Children's Hospital
Sponsor class: OTHER
First posted: 2016-02-03
Enrollment: 30
Sex: ALL
Minimum age (years): 11
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Health Behavior Inventory (HBI)
timeFrame: Baseline, Weekly from 1-6 weeks, 3 months, 6 months
Secondary outcomes:
measure: PedsQL
timeFrame: Baseline, 6 weeks, 3 and 6 months
measure: Fear of Pain Questionniare (FOPQ), child and parent
timeFrame: Trajectory from baseline, 6 weeks, 3 months, 6 months
measure: Moderate-vigorous physical activity (MVPA)
timeFrame: Baseline and 6 weeks
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
Study officials:
affiliation: Seattle Childrens Research Institute
name: Sara P Chrisman, MD MPH
role: PRINCIPAL_INVESTIGATOR
References: