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

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ClinicalTrials.gov Identifier: NCT02673112
Recruitment Status : Completed
First Posted : February 3, 2016
Last Update Posted : October 26, 2018
Sponsor:
Information provided by (Responsible Party):
Sara Chrisman, 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.

Condition or disease Intervention/treatment Phase
Persistent Concussion Symptoms Behavioral: Subthreshold exercise (STEP) with mobile health coaching Behavioral: Light stretching (LS) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Study of an Exercise Program (STEP) for Youth With Concussion
Study Start Date : April 2016
Actual Primary Completion Date : September 2017
Actual Study Completion Date : January 2018

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Health Behavior Inventory (HBI) [ Time Frame: 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 :
  1. PedsQL [ Time Frame: Baseline, 6 weeks, 3 and 6 months ]
    Health related quality of life

  2. Fear of Pain Questionniare (FOPQ), child and parent [ Time Frame: Trajectory from baseline, 6 weeks, 3 months, 6 months ]
    Measure of fear avoidance

  3. Moderate-vigorous physical activity (MVPA) [ Time Frame: Baseline and 6 weeks ]
    Hip-mounted research grade accelerometry



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Ages Eligible for Study:   11 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02673112


Locations
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United States, Washington
Seattle Children's Hospital
Seattle, Washington, United States, 98136
Sponsors and Collaborators
Seattle Children's Hospital
Investigators
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Principal Investigator: Sara P Chrisman, MD MPH Seattle Childrens Research Institute
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Responsible Party: Sara Chrisman, Assistant Professor, Seattle Children's Hospital
ClinicalTrials.gov Identifier: NCT02673112    
Other Study ID Numbers: 00000023
First Posted: February 3, 2016    Key Record Dates
Last Update Posted: October 26, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Sara Chrisman, Seattle Children's Hospital:
Concussion
mild traumatic brain injury
post concussion syndrome
child