Home-based Pulmonary Rehabilitation and Health Coaching to Improve Respiratory-related Quality of Life and Physical Activity in Fibrotic Interstitial Lung Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 81
- 试验地点
- 2
- 主要终点
- Physical activity
研究概览
简要总结
The purpose of this study is to gather information on the effectiveness of a home-based pulmonary rehabilitation program with health coaching and tele-monitoring for improving patient-reported respiratory-related quality of life and physical activity in patients with fibrotic Interstitial Lung Diseases (f-ILD).
详细描述
The home-based pulmonary rehabilitation program involves using a computer tablet paired with a pulse oximeter and activity tracker. Gentle upper body exercises, walking and a breathing practice are completed by following along on the computer tablet. Weekly check-in calls by telephone will be provided by a Health Coach to assess clinical status and monitor progress. The exercise portion of the program lasts 12 weeks. There are questionnaires and a research grade activity tracker measuring baseline and post-intervention findings at the end of 12-week period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of idiopathic pulmonary fibrosis (IPF) or other fibrotic interstitial lung disease, with a minimum of > 10% fibrosis on computed tomography imaging.
- •Clinically meaningful breathlessness: modified Medical Research Council (mMRC) dyspnea score >1.
排除标准
- •Inability to walk (orthopedic/neurologic/cardiac limitation causing immobility).
- •Cognitive impairment or inability to understand and follow instructions.
- •Traditional PR completed within 3 months of study recruitment.
- •Hospice or end-of-life care at the time of screening.
- •Acute exacerbation at the time of screening.
结局指标
主要结局
Physical activity
时间窗: Baseline, 12 weeks
Measured by mean number of steps per 24-hour period as assessed by Actigraphy, pre- and post-intervention
Change in patient-reported respiratory-related quality of life CRQ Physical Summary score
时间窗: Baseline, 12 weeks
Measured using the Chronic Respiratory Questionnaire (CRQ) survey which is a validated tool for measuring health status in patients with chronic lung disease divided into four domains of dyspnea, fatigue, emotion, and mastery. The Physical Summary score combines dyspnea and fatigue dimensions, a lower score suggests a greater degree of dysfunction on a 7-point scale. A difference of 0.5 in any domain is considered clinically significant (the minimal clinically important difference (MCID)). Higher total scores represent relatively better or improved patient-reported quality of life.
Change in patient-reported respiratory-related quality of life CRQ Emotional score
时间窗: Baseline, 12 weeks
Measured using the Chronic Respiratory Questionnaire (CRQ) survey which is a validated tool for measuring health status in patients with chronic lung disease divided into four domains of dyspnea, fatigue, emotion, and mastery. The emotional domain score is measured by a lower score suggests a greater degree of dysfunction on a 7-point scale. A difference of 0.5 in any domain is considered clinically significant (the minimal clinically important difference (MCID)). Higher total scores represent relatively better or improved patient-reported quality of life.
次要结局
- Self-reported tolerance of directed medical management(Baseline, 12 weeks)
- Qualitative assessment of patient-reported efficacy(12 weeks)