Home-Based Pulmonary Rehab for Patients With Pulmonary Fibrosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Functional performance
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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
干预措施: Physical exercise training (Behavioral)
Cognitive exercise training
Cognitive, brain-training, video gaming ~30 minutes per session, 3 times per week for 12 weeks
干预措施: Cognitive exercise training (Behavioral)
结局指标
主要结局
Functional performance
时间窗: 12 weeks
6-min walk distance (m)
次要结局
- 15-Step Test: Time(12 weeks)
- Exercise dyspnea(12 weeks)
- 15-Step Test: Recovery(12 weeks)
- Physical activity level(12 weeks)
- 15-Step Test: Exercise desaturation(12 weeks)
- Health-related quality of life(12 weeks)
研究者
John D Lowman, PT, PhD
Principal Investigator
University of Alabama at Birmingham