High Oxygen Delivery to Preserve Exercise Capacity in IPF Patients Treated With Nintedanib: The HOPE-IPF Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 16
- 主要终点
- Change from baseline in exercise duration during the constant load exercise test at 8 weeks
研究概览
简要总结
The purpose is to determine if patients with idiopathic pulmonary fibrosis (IPF) taking nintedanib will have improved exercise endurance, breathlessness and quality of life if breathing 60% oxygen compared to standard of care during an 8 week exercise training program.
详细描述
Pulmonary rehabilitation is a structured evidence-based exercise and education intervention that is recommended for most patients with IPF. Pulmonary rehabilitation improves functional capacity (6-minute walk distance [6MWD]), breathlessness and quality of life in patients, however these benefits are often modest and only temporary. Nintedanib is an antifibrotic medication that has been shown to slow the decline of lung function. Use of antifibrotic medications in the pulmonary rehabilitation setting may therefore allow prolonged benefit of exercise training by preventing IPF progression and the resulting worsening symptoms and functional decline. Unpublished data suggest that breathing 60% oxygen in a pulmonary rehabilitation setting could enable patients to train at higher exercise intensities and thus derive greater physiological adaptations and clinical benefits compared with traditional pulmonary rehabilitation.
This is a randomized, blinded study with two arms (standard of care or 60% oxygen). The decision to start or stop treatment with nintedanib will be made by the participants treating physician based on clinical findings. If the treating physician decides to discontinue nintedanib, the participant will be allowed to continue in the study.
The exercise training program is 8 weeks long, with visits 3 times a week. In addition to the exercise training there are 13 visits occurring before, during and after the 8 week exercise training program. At study visits, participants will be required to conduct a 6 minute walk test and complete a quality of life questionnaire. Select study visits will also require lung function tests and exercise tests to be conducted.
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 19 years or older
- •Idiopathic Pulmonary Fibrosis (IPF) diagnosis according to American Thoracic Society and/or European Respiratory Society consensus criteria
- •Appropriate candidate for pulmonary rehabilitation
- •prescribed nintedanib by their treating physician or currently on nintedanib
- •6 minute walk distance 50m or more
- •Oxygen saturation 92% or more by pulse oximetry at rest while breathing room air
- •Clinically stable for the preceding 6 weeks
排除标准
- •Contraindication to treatment with nintedanib (based on Canadian labeling)
- •Contraindication to exercise testing (e.g. significant cardiovascular, musculoskeletal, neurological disease)
- •Other significant extra-pulmonary disease that, based on clinical assessment, could impair exercise capacity and/or oxygenation
- •Forced vital capacity (FVC) less than 50% or Diffusion capacity for carbon monoxide (DLCO) less than 25%
- •Concurrent or recent participation (less than 6 months) in a pulmonary rehabilitation program
- •Use of prednisone greater than 10 mg/day for more than 2 weeks within 3 months of the first study visit
- •Use of pirfenidone within 4 weeks of screening
- •Significant emphysema (less than 10% volume on high resolution computed tomography (HRCT) or forced expiratory volume at one second (FEV1)/FVC less than 0.70)
研究组 & 干预措施
60% Oxgyen
While participants are exercising, they will be breathing 60% oxygen through a mask.
干预措施: 60% Oxygen (Other)
Standard of Care
While participants are exercising, they will be breathing air through a mask that will be titrated to keep oxygen saturation at least 88%, allowing a maximum inhaled oxygen percentage of 40%.
干预措施: Standard of Care (Other)
结局指标
主要结局
Change from baseline in exercise duration during the constant load exercise test at 8 weeks
时间窗: 8 weeks
An constant load exercise test on a stationary bike will be performed. Patients will be told to exercise for as long as possible and endurance time will be defined as the duration of the constant load exercise test.
次要结局
- Change in 6 Minute Walk Distance (6MWD) at 8 weeks(8 weeks)
- Change in the amount a patient is troubled by their breathlessness during the cycle exercise test at 8 weeks(8 weeks)
- Change in the amount a patient is troubled by their breathlessness at 8 weeks(8 weeks)
- Change in how much shortness of breath the patient experiences while doing normal activities at 8 weeks(8 weeks)
- Patient reported change in amount of physical activity at 8 weeks(8 weeks)
- Change in the amount of physical work a patient can do before becoming breathless at 8 weeks(8 weeks)
- Change in the amount a patient is troubled by their breathlessness during the 6 Minute Walk Distance test at 8 weeks(8 weeks)
- Change in amount of physical activity at 8 weeks(8 weeks)
- Change in Quality of Life at 8 weeks(8 weeks)
研究者
Chrisopher Ryerson
MD
University of British Columbia