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Mobile Subthreshold Exercise Program for Concussion

赞助:
合作者:
信息的提供 (责任方):
Sara Chrisman,Seattle Children's Hospital
September 27, 2018
October 1, 2018
October 1, 2018
March 6, 2018
September 1, 2019   (主要结果测量的最终数据收集日期)
Change in Health Behavior Inventory (HBI)[ Time Frame: Trajectory over 6 weeks (baseline, 3 weeks, 6 weeks) ]
Self-report questionnaire regarding concussive symptoms

与当前相同
  • Change in Pediatric Quality of Life Inventory (PedsQL)[ 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[ 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)[ Time Frame: Trajectory over 6 weeks (baseline, 3 weeks, 6 weeks) ]
    Self-report questionnaire of depression symptoms
  • Change in PROMIS Positive affect[ Time Frame: Trajectory over 6 weeks (baseline, 3 weeks, 6 weeks) ]
    Self-report questionnaire of positive mood levels
  • Change in moderate to vigorous physical activity (MVPA)[ Time Frame: Change from baseline to 6 weeks ]
    Average minutes per day of MVPA, measured using hip-mounted accelerometry
  • Change in Adolescent Sleep Wake Scale (ASWS)[ 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 Sport participation questionnaire[ Time Frame: Trajectory over 6 weeks (baseline, 3 weeks, 6 weeks) ]
    Self-report questionnaire regarding sporting and recreational activities that a youth participated in that week
  • Change in Physical activity parenting[ Time Frame: Trajectory over 6 weeks (baseline, 3 weeks, 6 weeks) ]
    Self-report questionnaire (completed by parents) regarding their approach to physical activity with their child.
  • Change in Adult responses to child's symptoms (ARCS), adapted for concussion[ Time Frame: Trajectory over 6 weeks (baseline, 3 weeks, 6 weeks) ]
    Self-report questionnaire regarding parenting responses to child's concussive symptoms
  • Change in Generalized anxiety disorder--7 item (GAD7)[ Time Frame: Trajectory over 6 weeks (baseline, 3 weeks, 6 weeks) ]
    Self-report questionnaire regarding anxiety symptoms (7-item)
 
Mobile Subthreshold Exercise Program for Concussion
Mobile Subthreshold Exercise Program (M-STEP) for Concussion

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.
Interventional
N/A
分配:
干预模型: Single Group Assignment
干预模型描述: All youth will receive the intervention
盲法: Interventional
盲法描述:
主要目的: Treatment
  • 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.
  • Experimental: M-STEP
    Mobile exercise intervention
 
Recruiting
30
与当前相同
September 1, 2019
September 1, 2019   (主要结果测量的最终数据收集日期)
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
参与研究的性别: All
最小年龄:9 Years ,最大年龄:18 Years  
没有
United States
 
No
研究美国FDA监管的药品: No
研究涉及美国FDA监管的设备产品: No
计划分享 IPD:
Sara Chrisman,Seattle Children's Hospital
Seattle Children's Hospital
Principal Investigator: Sara PD Chrisman, MD, MPH Seattle Children's Research Institute
Seattle Children's Hospital
September 2018

ICMJE     国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素
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