Home-Based Pulmonary Rehab for Patients With Pulmonary Fibrosis (EXPLORE-IPF)
Outpatient (phase 2) pulmonary rehab is an important, but mostly underutilized intervention to improve physical function in patients with idiopathic pulmonary fibrosis (IPF). Of those individuals who complete phase 2 pulmonary rehab, only a small cohort continues with any type of maintenance exercise therapy (phase 3). This is largely due to personal factors, such as access to transportation, weather, scheduling difficulties, and cost.
Little is known about how to enhance physical activity among patients with IPF. In addition, no studies have investigated the long-term maintenance strategies of physical training in patients with IPF. Thus, the purpose of this study is to test the feasibility and effectiveness of a home-based, pulmonary rehab program for patients with IPF. A randomized, blinded, clinical trial (RCT) design with two arms -- Wii Fit Plus exergame program and cognitive video gaming, with no active whole body movement involved - will be used to investigate the benefits of a home-based exergame program on improving pulmonary-related function and symptoms in patients with IPF.
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
Alabama
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Birmingham、Alabama、美国、35294-1212
- University of Alabama at Birmingham
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- confirmed diagnosis of IPF based on the criteria of the American Thoracic Society/European Respiratory Society 2011 guidelines;
- ≥ 40 years-of-age;
- ambulatory without the use of an assistive device;
- stable clinical condition (i.e., no pulmonary exacerbation for at least 6 weeks);
- no changes in medication for at least 4 weeks before enrollment;
- currently sedentary (i.e., exercise or participate in sports less than 3 times per week for 20 min in the past 6 months) and do not play any exergames;
- report dyspnea on exertion leading to a limitation in performing daily activities (i.e., Medical Research Council (MRC) dyspnea grade >1);
- able to read and follow exercise directions in English on the television screen;
- have permission from their treating physician to participate in moderate-intensity exercise;
- able to provide informed consent by understanding the nature of study participation.
Exclusion Criteria:
- contraindication for moderate-intensity exercise (e.g., unstable cardiac disease),
- severe musculoskeletal, vestibular, or neurological disorders limiting exercise performance, or inability to perform the 6-min walk test or 15-step test,
- requires > 6 lpm supplemental oxygen therapy via nasal cannula during exercise to maintain SpO2 >88%;
- MRC dyspnea grade 4 or 5; IPF patients with MRC dyspnea grade 4 or 5 have been reported to show little or no improvement, or deteriorated following pulmonary rehab;
- stage 2 hypertension,
- anemia (hemoglobin < 8 g/dL);
- collagen vascular disease;
- obstructive lung disease,
- non-parenchymal restrictive lung disease,
- occupational lung disease (pneumoconiosis, hypersensitivity pneumonitis),
- sarcoidosis,
- other idiopathic interstitial pneumonia;
- currently participating or have participated (in the past 30 days) in another clinical trial which can affect the outcomes of the proposed study; or
- planning to move out of Alabama within the next 6 months.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:Physical exercise training
Combined aerobic and resistance exercise for 30 or more minutes at least 3 times per week for 12 weeks using the Wii Fit Plus
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|
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有源比较器:Cognitive exercise training
Cognitive, brain-training, video gaming ~30 minutes per session, 3 times per week for 12 weeks
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Functional performance
大体时间:12 weeks
|
6-min walk distance (m)
|
12 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Exercise dyspnea
大体时间:12 weeks
|
Dyspnea level (Borg CR10) after completing the 15-step test oximetry test
|
12 weeks
|
|
15-Step Test: Time
大体时间:12 weeks
|
time (sec) to complete 15-step test
|
12 weeks
|
|
15-Step Test: Exercise desaturation
大体时间:12 weeks
|
Level of desaturation (%) during 15-step test
|
12 weeks
|
|
15-Step Test: Recovery
大体时间:12 weeks
|
Time to recovery to baseline oxygen saturation following 15-step test
|
12 weeks
|
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Physical activity level
大体时间:12 weeks
|
Time (min) spent per week in moderate-vigorous physical activity (assessed via an accelerometer)
|
12 weeks
|
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Health-related quality of life
大体时间:12 weeks
|
St George's Respiratory Questionnaire
|
12 weeks
|
合作者和调查者
调查人员
- 首席研究员:Hon K Yuen, PhD、University of Alabama at Birmingham
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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