A Mobile Health Exercise Prescription to Enhance Effectiveness of Antifibrotic Therapy in Patients With Idiopathic Pulmonary Fibrosis (IPF)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Daily Physical Activity
研究概览
简要总结
Patients with idiopathic pulmonary fibrosis (IPF) who are stable on antifibrotic therapy at least 3 months will be randomized to complete a 12-week home exercise intervention using an mHealth platform, plus a pre- and post-intervention monitoring period (4 weeks each) and in-person study assessments.
详细描述
Contemporary walk test endpoints in IPF trials may under-represent patient functional gains with antifibrotic therapy, which may be more effectively captured with long-term activity monitoring. Traditional pulmonary rehabilitation centers create a barrier to patient exercise accessibility and compliance, which is eliminated in a mobile health (mHealth) exercise training approach. In this study, 30 patients with IPF will be randomized into one of two arms. The exercise arm will receive a 12-week home exercise intervention using an mHealth platform plus pre- and post-intervention monitoring (4 weeks each). The non-exercise arm will be monitored for the same study duration. The primary end point is change from baseline in daily physical activity as a number of weekly exercise minutes qualifying as moderate to vigorous physical activity (MVPA), METS*minutes of exercise per week, and sedentary time minutes. Assessments will be performed primarily via in-person study visits at week 4 and week 16, as well as via daily recordings from mHealth monitoring devices.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 40-80 yrs at randomization
- •Diagnosis of idiopathic pulmonary fibrosis (IPF), consistent with the ATS 2018 Guidelines
- •Percent Forced Vital Capacity (%FVC) ≥50%
- •Percent Carbon Monoxide Diffusing Capacity (%DLCO) ≥30%
- •Willing and able to participate in an exercise regimen
- •Ambulatory without the use of an assistive device
- •Stable on antifibrotic therapy (pirfenidone or nintedanib) at least 3 months
- •No changes in other medication for at least 4 wks before enrollment
- •Must be able to read, write, and verbally communicate in English
排除标准
- •Forced expiratory volume in one second (FEV1)/FVC ratio <0.7 after administration of bronchodilator at screening
- •Expected to receive a lung transplant within 1 year from randomization or, for patients at sites in the United States, on a lung transplant waiting list at randomization
- •Known explanation for interstitial lung disease
- •History of asthma or chronic obstructive pulmonary disease
- •Active infection
- •Ongoing IPF treatments including investigational therapy, immunosuppresents (other than prednisone 20 mg daily and below) and cytokine modulating agents
- •Participation in a supervised exercise program including pulmonary rehab within the previous 12 months
- •History of unstable or deteriorating cardiac or pulmonary disease (other than IPF) within the previous 6 months
- •Major orthopedic, psychiatric, neurological, or other conditions that would impair performance of the study exercise outcomes
- •Require >5LPM supplemental O2 at rest
- •Currently pregnant
结局指标
主要结局
Daily Physical Activity
时间窗: 20 weeks
Daily activity as step counts, intensity (metabolic equivalents), and duration (METS\*min) of activity to identify number of minutes spent in moderate-to-vigorous physical activity (MVPA) vs. sedentary time
Rates of recruitment, adherence, completion and adverse events
时间窗: 20 weeks
As indicators of intervention feasibility.
次要结局
- IPF-specific version of the St. George Respiratory Questionnaire (SGRQ-I)(Week 4, Week 16, Week 20)
- King's Brief Interstitial Lung Disease (KBILD) Questionnaire(Week 4, Week 16, Week 20)
- Plasma brain natriuretic peptide (BNP)(Week 4, Week 16)
- Cardiopulmonary Exercise Testing (CPET)(Week 4, Week 16)
- Pulmonary Function Tests (PFT) with DLCO(Week 4, Week 16)
- Six Minute Walk Test (6MWT)(Week 4, Week 16)
- Oxygen Saturation (SpO2)(12 weeks)
- Seated Knee Extension Maximal Force and Fatigue Curve Test(Week 4, Week 16)
- Lower Extremity Power Test(Week 4, Week 16)
- Wall Squat Functional Strength Test(Week 4, Week 16)
- Borg Rating of Perceived Dyspnea Scale(20 weeks)
- IPF-specific version of the St. George Respiratory Questionnaire (SGRQ-I)(Week 4, Week 16, Week 20)
- King's Brief Interstitial Lung Disease (KBILD) Questionnaire(Week 4, Week 16, Week 20)
- Plasma brain natriuretic peptide (BNP)(Week 4, Week 16)
研究者
Mary Beth Brown
Associate Professor
University of Washington