MhOVE-PPH Study: Mobile Health Intervention to Improve Exercise in Pediatric PH
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Change in average daily step count from baseline to 12 weeks
研究概览
简要总结
Children and adults with pulmonary arterial hypertension (PAH) have severely reduced daily activity compared to healthy populations. In adults, investigators recently demonstrated that lower baseline daily step counts associated with increased risk of hospitalization and worsening WHO functional class; similarly, reduced step counts associate with hospitalization in children with PAH. This application builds on our recently completed NIH-funded pilot mobile health (mHealth) trial in adult patients with PAH which demonstrated the ability to remotely increase step counts. The investigators now aim to: (1) adapt our mHealth intervention to the developmental needs and interests of adolescents; and, (2) determine if our intervention increases step counts in adolescents, providing the foundation for a larger trial to assess the impact on quality of life and clinical outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adolescents between ages 13-19 years.
- •Diagnosed with idiopathic, heritable, or associated (connective tissue disease, drugs, or toxins) pulmonary arterial hypertension (PAH), or PAH due to simple congenital heart disease (i.e. atrial septal defect).
- •WHO functional class I-III
- •Stable PAH-specific medication regimen for three months prior to enrollment. Subjects with only a single diuretic adjustment in the prior three months will be included. Adjustments in IV prostacyclin for side effect management are allowed.
- •Forced vital capacity >65% predicted with no or minimal interstitial lung disease based on reviews of imaging studies by PI and medical monitor.
排除标准
- •Prohibited from normal activity due to wheelchair bound status, bed bound status, reliance on a cane/walker, activity-limiting angina, activity-limiting osteoarthritis, or other condition that limits activity.
- •Pregnancy
- •Diagnosis of PAH etiology other than idiopathic, heritable, or associated.
- •Functional class IV heart failure
- •Requirement of > 2 diuretic adjustment in the prior three months.
- •Preferred form of activity is not measured by an activity tracker (swimming, yoga, ice skating, stair master, or activities on wheels such as bicycling or rollerblading).
- •Involved in any other investigational intervention.
结局指标
主要结局
Change in average daily step count from baseline to 12 weeks
时间窗: Baseline to 12 weeks
To assess the effect of a mHealth intervention or no intervention on average daily step count from baseline to 12 weeks. Accelerometry is a direct measure of physical activity in patients' day-to-day lives. Step counts will be measured using the Fitbit device monitor, a lightweight device that has a three-axis acceleration sensor, altimeter, vibration motor, and optical heart rate monitor.
次要结局
- Difference in Echocardiographic maximal tricuspid regurgitant velocity from baseline to 12 weeks(Baseline to 12 weeks)
- Difference in Echocardiographic measurement of RV fractional area change (FAC) from baseline to 12 weeks(Baseline to 12 weeks)
- Time to clinical worsening(Baseline to 12 weeks)
- Change in Quality of Life as measured by the Short Form 36-Item Health Survey (SF-36)(Baseline to 12 weeks)
- Change in Quality of Life as measured by the emPHasis-10(Baseline to 12 weeks)
- Change in Quality of Life as measured by the Pediatric Quality of Life Inventory (PedsQL)(Baseline to 12 weeks)
- Change in Quality of Life as measured by the Pediatric Inventory for Parents (PIP)(Baseline to 12 weeks)
- Difference in total daily activity from baseline to 12 weeks(Baseline to 12 weeks)
- Difference in unadjusted raw daily steps from baseline to 12 weeks(Baseline to 12 weeks)
- Difference in total daily aerobic time from baseline to 12 weeks(Baseline to 12 weeks)
- Difference in frequency of goal attainment from baseline to 12 weeks(Baseline to 12 weeks)
- Difference in mean daily steps during week 12 and week 18(Week 12 & Week 18)
- Difference in B-type natriuretic peptide levels from baseline to 12 weeks(Baseline to 12 weeks)
- Difference in 6-Minute walk test distance from baseline to 12 weeks(Baseline to 12 weeks)
- Difference in Echocardiographic pericardial effusion from baseline to 12 weeks(Baseline to 12 weeks)
研究者
Eric Austin
Director, Vanderbilt Pediatric Pulmonary Hypertension Program (Allergy/Immunology/Pulmonary Medicine) and Associate Professor of Pediatrics (Allergy/Immunology/Pulmonary Medicine)
Vanderbilt University Medical Center