Rehabilitation of IPF Patients: Effects of Exercise and Oxidant Stress
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- 6 Minute Walk Distance
研究概览
简要总结
The incidence and prevalence of IPF increase exponentially with age, and IPF occurs more often in older males. Cigarette smoking and environmental dust exposures are known risk factors for developing IPF. For example, the recently deployed military population, as it ages, is at especially increased risk of IPF. No effective therapies exist, although lung transplantation is used to extend survival of selected patients.
Defining specific therapy to improve exercise tolerance and dyspnea in IPF patients is thus an urgent priority of veteran-oriented research programs.
详细描述
Chronic lung disease is common in the veteran population. While chronic obstructive pulmonary disease (COPD) is most prominent, fibrotic lung diseases, typified by idiopathic pulmonary fibrosis (IPF), are clearly increasing. We have developed extensive experience with a VA idiopathic pulmonary fibrosis (IPF) population in the context of a randomized, controlled clinical trial of vasodilator therapy.
Based on the current literature and our preliminary experience with exercise testing in IPF patients, we hypothesize that:
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Formal pulmonary rehabilitation (i.e., an aerobic exercise program) will result in improved outcomes for IPF patients, demonstrable as an:
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Increase in exercise tolerance as quantified by 6-minute walk test (MWT) distance;
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Decrease in post-exercise dyspnea as quantified by the Borg dyspnea scale; and an
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Overall subjective improvement in quality of life as quantified by Saint George's Respiratory Questionnaire.
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Metabolic and physiologic mechanisms of improved exercise tolerance and decreased dyspnea will include:
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More efficient oxygen metabolism demonstrated by maximum O2 uptake (VO2max);
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Decreased post-exercise oxidant stress demonstrated by post-exercise isoprostanes and plasma total antioxidant capacity (TAC); and,
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Maintenance of maximum inspiratory and expiratory pressures (PInmax and PExmax).
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
- 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
- •Clinical presentation consistent with IPF with onset between three months and 48 months prior to screening.
- •Diagnosis made by high-resolution computed tomographic scan showing highly probable IPF.
- •Absence of severe pulmonary hypertension (i.e., PAsys must be less than 55 mm Hg, based on echocardiography) and absence of decompensated right heart failure (NYHA class I or II acceptable).
- •Age 40 through 80, inclusive.
- •Abnormal pulmonary function tests (FVC 40-90% predicted or DLCO 30-90% predicted or impaired gas exchange with rest or exercise).
- •Six-minute walk distance 150 m and 500 m.
- •Worsening as demonstrated by any one of the following within the past year: > 10% decrease in percent predicted forced vital capacity or worsening dyspnea at rest or upon exertion, based on history.
- •Ability to understand and sign a written informed consent form and comply with the requirements of the study.
- •Absence of clinical features suggesting infection, neoplasm, sarcoidosis or collagen-vascular disease.
排除标准
- •Echocardiographic evidence of severe pulmonary hypertension (PAsys>55 mm Hg, based on echocardiography or TR velocity 3.2 m/sec).
- •Severe heart failure (NYHA class III or IV or LVEF < 45%).
- •Six-minute walk distance < 150 m or > 500 m.
- •FEV1/FVC ratio < 0.7 at screening (post-bronchodilator).
- •Residual volume > 100% predicted.
- •Any condition other than IPF likely to result in the death of the participant within the next two years.
- •History of unstable or deteriorating cardiac or neurologic disease.
- •Pregnancy or lactation. Patients who are: (a) pregnant or (b) breast feeding are excluded from the study.
- •Current treatment with corticosteroids (either oral or inhaled), Cytoxan, azathioprine, colchicine, pirfenidone, anti-tumor necrosis factor therapy or endothelin receptor blockers. Prior treatment is permitted, but at least four weeks of treatment washout prior to inclusion in this study are required.
- •Investigational therapy for any indication within 28 days prior to enrollment.
- •Degenerative arthritis, cerebrovascular accident or other limitation to mobility preventing completion of the 6-minute walk test.
- •Oxygen saturation on room air <80% at rest.
结局指标
主要结局
6 Minute Walk Distance
时间窗: The 6-MWD will be measured at 0 and 3 months.
Change in 6 Minute Walk Distance from Baseline to 3 Months
次要结局
- Systemic Markers of Oxidant Stress(Markers of oxidant stress will be measured in all subjects before randomization after exercise testing at 0 months.)
- Maximum Oxygen Uptake(Maximum O2 uptake will be measured at 0 and 3 months.)