Status
Conditions
Treatments
About
Interstitial lung disease (ILD) is the result of over 200 etiological pathways arising from several different insults to the lung parenchyma: inhaled substances, drug side effects, connective tissue disease, infection, and malignancy. The disease can also be of idiopathic origin. If prolonged, the resulting inflammation causes permanent and progressive fibrotic reorganization of the parenchyma and small airways, which reduces the distensibility of the lung and impedes O2 and carbon dioxide (CO2) exchange.
This study is a randomized controlled trial to determine the safety and efficacy of aerobic exercise for patients who have interstitial lung disease (ILD) uncomplicated by pulmonary hypertension. In an uncontrolled study, we observed more efficient cardiorespiratory function, increased physical work capacity, and improved health-related quality of life following aerobic exercise in this study population. Serious adverse events resulting from aerobic exercise training were not observed and our work to date has established plausibility for the efficacy of aerobic exercise training and its safety for patients with ILD.
Full description
There are two primary treatment conditions. Patients with ILD are be randomized to either an intervention consisting of aerobic exercise training plus patient education or a control condition that includes patient education only. Aerobic exercise training will consist of a 10-week regimen of supervised treadmill walking three times a week. The duration of the exercise sessions will progress from 30 minutes to 45 minutes per session over the 10 weeks, as tolerated. The intensity of the exercise will be determined based on results of a cardiopulmonary exercise test. Those randomized to control will not initially engage in aerobic exercise training. There will, however, be a secondary study: a crossover design in which subjects in the control group will complete the aerobic exercise regimen.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
A diagnosis of interstitial lung disease, including idiopathic pulmonary fibrosis (IPF), non-specific interstitial pneumonitis (NSIP), sarcoidosis, or other form of chronic lung fibrosis based on clinical context via clinic note from a pulmonologist.
Individuals with ILD referred for pulmonary rehabilitation who are 21-80 years of age and live in the Washington metropolitan area.
No episodes of fainting or significant chest pain for at least one month.
No prior pulmonary rehabilitation received within the last 6 months and not currently in a maintenance program.
Physically inactive (no participation in a structured exercise program as defined as more than 30 minutes of exercise 3 or more days a week within the last 6 months).
EXCLUSION CRITERIA:
Other medical conditions that would impair aerobic capacity or the ability to engage in physical activity, including other pulmonary, cardiovascular, neurological, musculoskeletal or metabolic conditions
Other medical conditions that may pose a risk to exercise testing or training as determined by the investigators (for example, peripheral vascular disease)
Diagnosis of pulmonary hypertension
Inability to maintain a resting oxygen saturation greater than or equal to 90% SpO2, measured by pulse oximetry on supplemental oxygen
Inability to complete a treadmill cardiopulmonary exercise test.
Significant hepatic or renal dysfunction.
Metastatic cancer with a life expectancy of less than one year.
Active substance abuse.
Severe psychiatric disease
Antiretroviral therapy
Pregnancy
Ongoing tobacco use
Acceptance onto a lung transplant waiting list
Active participation in ILD drug trials
Inability to read English
Primary purpose
Allocation
Interventional model
Masking
46 participants in 2 patient groups
Loading...
Central trial contact
Gayle S McCrossin, C.R.N.P.; Leighton Chan, M.D.
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal