The Department of Veterans Affairs recently completed a randomized controlled-trial aimed to test the efficacy of an interventional pulmonary rehabilitation-structured exercise program for patients with Idiopathic Pulmonary Fibrosis.
The incidence and prevalence of Idiopathic Pulmonary Fibrosis (IPF) progressively increases with age, being mostly reflected in older males. Risk factors for IPF include cigarette smoking and environmental dust exposures. As a result, the deployed military population is at increased risk. To this point, as there are no effective treatments for IPF aside from lung transplantation, the Department of Veterans Affairs designed a veteran-oriented exercise program in order to reduce dyspnea and increase exercise tolerance in IPF patients.
The randomized interventional program called “Rehabilitation of IPF Patients: Effects of Exercise and Oxidant Stress” (ClinicalTrials.gov Identifier: NCT01118221), randomly assigned IPF patients aged between 40 and 80 years to one of two study groups: patients under the experimental arm (N=11) were tested for a behavioral pulmonary rehabilitation structured exercise program for a 3-month duration. The other group was subject to no intervention (N=10).
The study’s primary assessment endpoints were a 6 Minute Walk Distance test measured at 0 and 3 months, and change in 6 Minute Walk Distance from Baseline to 3 Months. The study’s secondary endpoint included Systemic Markers of Oxidant Stress, measured in all subjects before randomization after exercise testing at 0 months, and plasma F2-isoprostanes measured in all subjects before and after exercise testing at baseline. Furthermore, IPF patients were assessed for Maximum Oxygen Uptake, measured at 0 and 3 months, and Change in 6 peak O2 uptake from Baseline to 3 Months.
The study inclusion criteria included: Diagnosis of highly probable IPF (assessed by high-resolution computed tomographic) with onset between three months and 48 months prior study entry; absence of severe pulmonary hypertension; 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; Decline in lung functioning in the past 12 months( > 10% decrease in percent predicted forced vital capacity or worsening dyspnea at rest or upon exertion); Ability of consent; and absence of infection, neoplasm, sarcoidosis or collagen-vascular disease.
Participants were considered excluded if there was chocardiographic 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; if they suffered from any other condition 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; treatment with corticosteroids, cytoxan, azathioprine, colchicine, pirfenidone, anti-tumor necrosis factor therapy or endothelin receptor blockers; Degenerative arthritis, cerebrovascular accident or other limitation to mobility preventing completion of the 6-minute walk test; and Oxygen saturation on room air <80% at rest.
Results from this study are expected to be announced soon.