About this trial
Dyspnea (i.e. breathlessness) and exercise intolerance are common symptoms for patients with interstitial lung disease (ILD), yet it is not known why. It has been suggested that muscle dysfunction may contribute to dyspnea and exercise intolerance in ILD. Our study aims to: i) examine differences in the structure and function of the leg muscles in ILD patients, ii) determine if leg muscle fatigue contributes to dyspnea and exercise limitation in patients with ILD, and iii) determine the effects of breathing extra oxygen on leg muscle fatigue, as well as ability to exercise in ILD patients.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age 40-80 years (inclusive)
A multidisciplinary diagnosis of idiopathic pulmonary fibrosis (IPF), idiopathic fibrotic nonspecific interstitial pneumonia (NSIP), chronic hypersensitivity pneumonitis (HP), or unclassifiable ILD with a differential diagnosis that consists of the above diagnoses
Fibrosis on high resolution computed tomography (HRCT): honeycombing, reticulation, or traction bronchiectasis
Appropriate candidate for pulmonary rehabilitation
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Hyperoxia
Biological/VaccineParticipants breathe 60% oxygen during exercise
Treatment groups
Trial outcomes
Primary outcomes
Change in standardized dyspnea score during the constant load exercise test (visit 3)
Dyspnea rating, measured using the Borg 0-10 category ratio scale, will be assessed every 1 minute during the constant-load exercise test on visit 3.
Change in standardized dyspnea score during the constant load exercise test (visit 4)
Dyspnea rating, measured using the Borg 0-10 category ratio scale, will be assessed every 1 minute during the constant-load exercise test on visit 4.
Change in leg muscle strength measured following the constant load exercise test (visit 3)
Leg muscle strength will be measured before (at rest) and 3 min after the constant-load exercise test on visit 3 using the femoral magnetic stimulation technique.
Change in leg muscle strength measured following the constant load exercise test (visit 4)
Leg muscle strength will be measured before (at rest) and 3 min after the constant-load exercise test on visit 4 using the femoral magnetic stimulation technique.
Secondary outcomes
Quadriceps muscle oxidative capacity measured using near-infrared spectroscopy
Quadriceps muscle oxidative capacity will measured using near-infrared spectroscopy. Parameters will be measured over 5 minutes once on visit 2
Quadriceps muscle volume measured using magnetic resonance imaging
Quadriceps muscle volume will be measured using magnetic resonance imaging. Parameters will be measured over 15 minutes once on visit 2
Sponsors and contacts
Click on the lead sponsor to view all of their trials.