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To compare the efficacy of a sub-threshold aerobic exercise intervention provided with mobile health coaching (STEP-mhc) and a light stretching program (LS) to LS alone for 11-18 yo youth with persistent concussion symptoms.
This is a minimal risk randomized controlled trial whose aim is to test the efficacy of an exercise intervention (STEP) for youth 11-18 yo with persistent concussive symptoms (1-6 months inclusive). The investigators are utilizing an active control (light stretching). The primary outcome will be concussion symptoms measured with the Health-Behavior Inventory (HBI) in the first month after randomization. Long-term efficacy will be examined using standardized measures of quality of life and function over 6 months, and potential mediators will be explored including brain derived neurotrophic factor (BDNF), fear-avoidance and physical fitness. Physical activity will be measured with accelerometry to evaluate fidelity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| STEP-mhc + LS | Experimental | Subjects will be asked to perform exercise at 80% of the heart rate threshold determined using the Balke protocol for 5 minutes greater than their measured minutes of MVPA/day at baseline (Subthreshold exercise program). They will also be given a light stretching protocol (5 stretches). The exercise intervention will last for 6 weeks and will be supported by weekly health coaching. |
|
| LS alone | Active Comparator | Subjects will be given a light stretching program alone (5 stretches). The exercise program will last for 6 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Subthreshold exercise (STEP) with mobile health coaching | Behavioral | Aerobic exercise program performed below the HR threshold that causes symptoms and administered by an RA using mobile health coaching |
| Measure | Description | Time Frame |
|---|---|---|
| Health Behavior Inventory (HBI) | Measure change in concussion symptoms from the baseline evaluation to post-intervention (6 weeks) using HBI. | Baseline, Weekly from 1-6 weeks, 3 months, 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| PedsQL | Health related quality of life | Baseline, 6 weeks, 3 and 6 months |
| Fear of Pain Questionniare (FOPQ), child and parent | Measure of fear avoidance |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sara P Chrisman, MD MPH | Seattle Childrens Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seattle Children's Hospital | Seattle | Washington | 98136 | United States |
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| ID | Term |
|---|---|
| D001924 | Brain Concussion |
| D038223 | Post-Concussion Syndrome |
| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Light stretching (LS) | Behavioral | Brief daily stretching routine. |
|
| Trajectory from baseline, 6 weeks, 3 months, 6 months |
| Moderate-vigorous physical activity (MVPA) | Hip-mounted research grade accelerometry | Baseline and 6 weeks |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D016489 | Head Injuries, Closed |
| D014947 | Wounds and Injuries |
| D014949 | Wounds, Nonpenetrating |