Mobile Subthreshold Exercise Program for Concussion

Not Applicable

Completed

• Conditions: Brain Concussion
• Interventions: Behavioral: M-STEP

• Registration Number: NCT03691363
• Lead Sponsor: Seattle Children's Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2018-03-06
• Study First Submitted: 2018-09-27
• Study First Submitted QC: 2018-09-28
• Study First Posted: 2018-10-01
• Primary Completion: 2019-09-01
• Study Completion: 2019-09-01
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-04
• Last Update Posted: 2021-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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

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Exclusion Criteria

• Already participating in >30 minutes of MVPA/day

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
M-STEP	M-STEP	Mobile exercise intervention

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change in Patient Health Questionnaire 9 (PHQ-9), 9 item 0-3 likert, higher scores indicate greater symptoms	Trajectory over 6 weeks (baseline, 3 weeks, 6 weeks)	Self-report questionnaire of depression symptoms
Change in Pediatric Quality of Life Inventory (PedsQL), 23 item 0-4 likert, converted to a 0-100 scale, higher scores indicate improved function	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	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 Adolescent Sleep Wake Scale (ASWS), 10-item 0-5 likert, higher scores indicate improved sleep quality	Trajectory over 6 weeks (baseline, 3 weeks, 6 weeks)	Self-report 10-item questionnaire regarding difficulty falling asleep, night wakenings and other sleep issues
Study Satisfaction Questionnaire	6 weeks	8 item survey regarding satisfaction with study, 0-3 likert, higher scores indicate greater satisfaction
Change in Generalized anxiety disorder--7 item (GAD7), 7-item 0-3 likert, higher scores indicate more severe symptoms	Trajectory over 6 weeks (baseline, 3 weeks, 6 weeks)	Self-report questionnaire regarding anxiety symptoms (7-item)

Trial Locations

Locations (1)

Seattle Children's Hospital; 🇺🇸 Seattle, Washington, United States