Mobile Subthreshold Exercise Program for Concussion

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

Detailed Description
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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.

Official Title
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Mobile Subthreshold Exercise Program (M-STEP) for Concussion

Conditions
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Brain Concussion

Intervention / Treatment
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* Behavioral: M-STEP


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 9 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: All youth will receive the intervention
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: M-STEP<br>Mobile exercise intervention | Behavioral: M-STEP<br>* 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.<br>* Other names: Sub-threshold exercise;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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child, Adolescent, exercise, rehabilitation, physical activity, virtual, mobile health