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

NCT ID: NCT02673112

Last Updated: 2018-10-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2018-01-31

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.

Conditions

Persistent Concussion Symptoms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Subthreshold exercise (STEP) with mobile health coaching

Intervention Type: BEHAVIORAL

Aerobic exercise program performed below the HR threshold that causes symptoms and administered by an RA using mobile health coaching

Light stretching (LS)

Intervention Type: BEHAVIORAL

Brief daily stretching routine.

LS alone

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

Group Type: ACTIVE_COMPARATOR

Light stretching (LS)

Intervention Type: BEHAVIORAL

Brief daily stretching routine.

Interventions

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

Intervention Type: BEHAVIORAL

Light stretching (LS)

Brief daily stretching routine.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 11 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seattle Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Sara Chrisman

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sara P Chrisman, MD MPH

Role: PRINCIPAL_INVESTIGATOR

Seattle Childrens Research Institute

Locations

Seattle Children's Hospital

Seattle, Washington, United States

Countries

United States

Other Identifiers

00000023

Identifier Type: -

Identifier Source: org_study_id