Hyperoxia: Participants breathe 60% oxygen during exercise
Study summary
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
Sex
ALL
Min age
40 Years
Max age
80 Years
Healthy volunteers
Accepted
Inclusion Criteria for ILD Patients:
* 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
* 6 minute walk distance 50m or more
* Oxygen saturation ≥ 92% by pulse oximetry at rest while breathing room air
* Clinically stable for the preceding 6 weeks
* Can fluently read and write in English
Inclusion Criteria for Healthy Controls:
* Age 40-80 (inclusive)
* Normal pulmonary function (80-120% predicted)
* No lung or cardiovascular disease
* Can fluently read and write in English
Exclusion Criteria for the ILD patients:
* 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
* Significant emphysema (less than 10% volume on HRCT or FEV1/FVC less than 0.70)
Exclusion Criteria for Healthy Controls:
* Currently smoking or previously smoked more than 10 pack-years
* Any medical conditions that prevents them for exercising safely
* Cardiac pacemaker or any metal or electronic inside the body
Primary outcome measure(s)
Change in standardized dyspnea score during the constant load exercise test (visit 3) — Dyspnea will be measured once every minute during exercise on visit 3 (up to 7 weeks after baseline) until participants reach volitional exhaustion (assessed for up to 30 minutes) 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 will be measured once every minute during exercise on visit 4 (up to 8 weeks after baseline) until participants reach volitional exhaustion (assessed for up to 30 minutes) 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 and after exercise (assessed for up to 40 minutes) on visit 3 (up to 8 weeks after baseline) 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 and after exercise (assessed for up to 40 minutes) on visit 4 (up to 8 weeks after baseline) 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.
Trial sites (1)
Facility
City
Region
Status
St. Paul's Hospital
Vancouver
British Columbia
Recruiting
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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