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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