Mobile Subthreshold Exercise Program for Concussion

Overview

Non-randomized pilot intervention using mobile-administered sub-threshold exercise to treat youth with prolonged symptoms of concussion.

Full Title of Study: “Mobile Subthreshold Exercise Program (M-STEP) for Concussion”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 1, 2019

Detailed Description

6-week pilot study of a novel intervention for concussion, administering a sub-threshold exercise program in a mobile fashion using video conferencing and providing feedback using wrist-worn accelerometry and heart rate monitoring.

Interventions

  • Behavioral: M-STEP
    • Youth will be assessed using actigraphy at baseline, and will then be asked to exercise for 1) a duration of 10 minutes > MVPA at baseline with 2) HR>120 while being monitored by a Fitbit. Youth will be asked to exercise daily, and intensity and duration will be increased every few days for a goal of 60 minutes per day at a HR>140 (low end of MVPA). The intervention will be 6 weeks in duration.

Arms, Groups and Cohorts

  • Experimental: M-STEP
    • Mobile exercise intervention

Clinical Trial Outcome Measures

Primary Measures

  • Change in Health Behavior Inventory (HBI), 21 item 0-3 likert, higher scores indicate more severe symptoms
    • Time Frame: Trajectory over 6 weeks (baseline, 3 weeks, 6 weeks)
    • Self-report questionnaire regarding concussive symptoms

Secondary Measures

  • Change in Pediatric Quality of Life Inventory (PedsQL), 23 item 0-4 likert, converted to a 0-100 scale, higher scores indicate improved function
    • Time Frame: Trajectory over 6 weeks (baseline, 3 weeks, 6 weeks)
    • Self-report questionnaire regarding Health-related quality of life
  • Change in Fear of pain questionnaire (FOPQ)-P/C, adapted for concussion, 24 item (child) and 23 item (parent) 0-4 likert, higher scores indicate greater fear-avoidance
    • Time Frame: Trajectory over 6 weeks (baseline, 3 weeks, 6 weeks)
    • Self-report questionnaire completed by parent and child regarding their fear of concussive symptoms and avoidance of activities that might produce concussive symptoms
  • Change in Patient Health Questionnaire 9 (PHQ-9), 9 item 0-3 likert, higher scores indicate greater symptoms
    • Time Frame: Trajectory over 6 weeks (baseline, 3 weeks, 6 weeks)
    • Self-report questionnaire of depression symptoms
  • Change in Adolescent Sleep Wake Scale (ASWS), 10-item 0-5 likert, higher scores indicate improved sleep quality
    • Time Frame: Trajectory over 6 weeks (baseline, 3 weeks, 6 weeks)
    • Self-report 10-item questionnaire regarding difficulty falling asleep, night wakenings and other sleep issues
  • Change in Generalized anxiety disorder–7 item (GAD7), 7-item 0-3 likert, higher scores indicate more severe symptoms
    • Time Frame: Trajectory over 6 weeks (baseline, 3 weeks, 6 weeks)
    • Self-report questionnaire regarding anxiety symptoms (7-item)
  • Study Satisfaction Questionnaire
    • Time Frame: 6 weeks
    • 8 item survey regarding satisfaction with study, 0-3 likert, higher scores indicate greater satisfaction

Participating in This Clinical Trial

Inclusion Criteria

  • Concussion diagnosed by a healthcare provider that occurred 2 weeks-6 months ago – Continued symptoms with at least 3 symptoms on the HBI and a score of 20+ – No other issues that would preclude physical activity – Parents and youth are English-speaking Exclusion Criteria:

  • Already participating in >30 minutes of MVPA/day

Gender Eligibility: All

Minimum Age: 9 Years

Maximum Age: 25 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Seattle Children’s Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Sara PD Chrisman, MD MPH, Assistant Professor – Seattle Children’s Hospital
  • Overall Official(s)
    • Sara PD Chrisman, MD, MPH, Principal Investigator, Seattle Children’s Research Institute

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