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Non-randomized pilot intervention using mobile-administered sub-threshold exercise to treat youth with prolonged symptoms of concussion.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| M-STEP | Experimental | Mobile exercise intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| M-STEP | Behavioral | 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. |
| 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) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
- Already participating in >30 minutes of MVPA/day
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| Name | Affiliation | Role |
|---|---|---|
| Sara PD Chrisman, MD, MPH | Seattle Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seattle Children's Hospital | Seattle | Washington | 98104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34123963 | Derived | Chrisman SPD, Mendoza JA, Zhou C, Palermo TM, Gogue-Garcia T, Janz KF, Rivara FP. Pilot Study of Telehealth Delivered Rehabilitative Exercise for Youth With Concussion: The Mobile Subthreshold Exercise Program (MSTEP). Front Pediatr. 2021 May 28;9:645814. doi: 10.3389/fped.2021.645814. eCollection 2021. |
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| ID | Term |
|---|---|
| D001924 | Brain Concussion |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| C000601529 | SE 1-step Futurabond M |
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All youth will receive the intervention
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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 |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D016489 | Head Injuries, Closed |
| D014947 | Wounds and Injuries |
| D014949 | Wounds, Nonpenetrating |
| D001519 | Behavior |