NCT03691363已完成不适用
Mobile Subthreshold Exercise Program (M-STEP) for Concussion
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Change in Health Behavior Inventory (HBI), 21 item 0-3 likert, higher scores indicate more severe symptoms
研究概览
简要总结
Non-randomized pilot intervention using mobile-administered sub-threshold exercise to treat youth with prolonged symptoms of concussion.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 9 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Already participating in >30 minutes of MVPA/day
研究组 & 干预措施
M-STEP
Experimental
Mobile exercise intervention
干预措施: M-STEP (Behavioral)
结局指标
主要结局
Change in Health Behavior Inventory (HBI), 21 item 0-3 likert, higher scores indicate more severe symptoms
时间窗: Trajectory over 6 weeks (baseline, 3 weeks, 6 weeks)
Self-report questionnaire regarding concussive symptoms
次要结局
- 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))
- 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))
- 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))
- 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))
- Study Satisfaction Questionnaire(6 weeks)
- 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))
研究者
Sara PD Chrisman, MD MPH
Assistant Professor
Seattle Children's Hospital
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Study of an Exercise Program (STEP) for Youth With ConcussionPersistent Concussion SymptomsNCT02673112Seattle Children's Hospital30
已完成
不适用
A Brief Intervention for Alcohol Users With Interpersonal TraumaHeavy DrinkingSubstance UseDrinking BehaviorAlcohol DrinkingNCT05414344Western Kentucky University284
已完成
不适用
Mobile Health Intervention to Identify Early Responders to Treatment in Adolescent ObesityAdolescent ObesityNCT03561597KK Women's and Children's Hospital40
撤回
不适用
Mobile Intervention Supervised Exercise Therapy Study 1Claudication, IntermittentPeripheral Artery DiseaseNCT04832308Palo Alto Veterans Institute for Research
已完成
不适用
mHealth Intervention for Work-Related StressWork Related StressNCT06228495Karolinska Institutet16