Recruiting

Observational Study

Sponsor:

University of British Columbia

Code:

NCT03800017

Conditions

Interstitial Lung Disease

Idiopathic Pulmonary Fibrosis

Hypersensitivity Pneumonitis

Scleroderma

Nonspecific Interstitial Pneumonia

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Accepted

Interventions

Hyperoxia

Study Details

Brief 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.

Conditions

Interstitial Lung Disease

Idiopathic Pulmonary Fibrosis

Hypersensitivity Pneumonitis

Scleroderma

Nonspecific Interstitial Pneumonia

Study ID

NCT03800017

Start date

Aug 7, 2024

Status verified date

May, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70+

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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Hyperoxia

During exercise on visit 4, participants in both groups (i.e., ILD patients and controls) will breathe supplemental oxygen (i.e., 60% oxygen) during constant-load exercise.

placebo comparator: Healthy Controls

During exercise on visit 3, participants in both groups (i.e., ILD patients and controls) will breathe ambient air (i.e., 20.93% oxygen) during constant-load exercise.

Interventions

Hyperoxia

Participants breathe 60% oxygen during exercise

Primary outcome measure

  • Change in standardized dyspnea score during the constant load exercise test (visit 3) [ Time Frame: 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) ]
  • Change in standardized dyspnea score during the constant load exercise test (visit 4) [ Time Frame: 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) ]
  • Change in leg muscle strength measured following the constant load exercise test (visit 3) [ Time Frame: 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) ]
  • Change in leg muscle strength measured following the constant load exercise test (visit 4) [ Time Frame: 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) ]

Central Contacts and Locations

Central contacts

Olivia Ferguson, MSc

1-604-806-8835Olivia.Ferguson@hli.ubc.ca

Satvir S Dhillon, MSc

1-604-806-8835Satvir.Dhillon@hli.ubc.ca

Locations

St. Paul's Hospital

Recruiting

Vancouver, British Columbia, Canada, V6Z1Y6

Contacts

Satvir S Dhillon, MSc

604-806-8835satvir.dhillon@hli.ubc.ca

More Information

Sponsor

University of British Columbia

Last update posted

May 15, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of British Columbia on 2026-05-15.