Recruiting
Phase 2

Oxygen Therapy

Sponsor:

University of Alberta

Code:

NCT06053164

Conditions

Fibrotic Interstitial Lung Disease

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Exertional Oxygen

Education and Support

Study Details

Brief summary:

The investigators plan to conduct a study to find out if giving portable oxygen therapy (during physical activity) to patients with interstitial lung disease will improve quality of life, exercise tolerance, shortness of breath, and blood vessel function. Oxygen will be provided for a period of 8 weeks. Additionally, the investigators plan to investigate if it is helpful to deliver individualized support when providing oxygen therapy, through check-in phone calls with a respiratory therapist and by providing additional educational material.

Conditions

Fibrotic Interstitial Lung Disease

Study ID

NCT06053164

Start date

Jul 1, 2025

Status verified date

Jul, 2026

Completion date

Sep 1, 2026

Anticipated

Primary completion date

Sep 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Individuals with fibrotic ILD (all sub-groups of ILD) who have normal oxygen saturation at rest (SpO2 > 90%) but develop exertional hypoxemia as demonstrated by a SpO2 = 80-89% with activity (measured during 6MWT).

Exclusion Criteria:

  • Use of home oxygen therapy within the previous year for the management of ILD, co-morbid conditions that may require oxygen therapy (such as COPD, cardiovascular disease, or other illnesses), or individuals that require the use of non-invasive ventilation. Additionally, individuals with significant cardiovascular, metabolic, neuromuscular or any other disease that could contribute to dyspnea or abnormal cardiopulmonary responses to exercise will be excluded. Individuals with musculoskeletal injuries that prevent them from completing cycle ergometry exercise trials and ambulation will also be excluded. Individuals with peripheral vascular disease will be excluded from measurement of vascular function (flow mediated dilation).

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: Arm 1 - Usual Care

8 weeks of usual care with no supplemental oxygen provided

experimental: Arm 2 - Exertional Oxygen

8 weeks of portable oxygen use (from a concentrator) during exertion

experimental: Arm 3 - Exertional Oxygen + Support

8 weeks of portable oxygen use (from a concentrator) during exertion, plus additional phone calls with a respiratory educator and educational material

Interventions

Exertional Oxygen

Use of a portable oxygen concentrator for exertional activities lasting >2 minutes

Education and Support

Participants will receive disease-specific educational material (Living Well with Pulmonary Fibrosis: Oxygen), and will have scheduled phone appointments with a certified respiratory educator after 1, 3, and 5 weeks of oxygen therapy in order to address individual barriers to oxygen use and facilitate the optimal use of portable oxygen.

Primary outcome measure

  • Feasibility of investigation [ Time Frame: 2 years ]
  • Exercise tolerance [ Time Frame: Before and immediately after the intervention ]
  • Health Related Quality of Life, (EuroQol-5 Dimension-5 Level; EQ-5D-5L) [ Time Frame: Before and immediately after the intervention ]
  • Health Related Quality of Life, (King's Brief Interstitial Lung Disease Questionnaire; KBILD) [ Time Frame: Before and immediately after the intervention ]

Central Contacts and Locations

Central contacts

Matt Rieger, PhD

7804928027mrieger@ualberta.ca

Desi Fuhr, MSc

780.492.1121fuhr@ualberta.ca

Locations

Clinical Physiology Laboratory

Recruiting

Edmonton, Alberta, Canada, T6G2R3

Contacts

Desi Fuhr, MSc

780-492-1121fuhr@ualberta.ca

Michael K Stickland, PhD

780-492-3995michael.stickland@ualberta.ca

More Information

Sponsor

University of Alberta

Last update posted

Jul 9, 2026

Last verified

Jul, 2026

Keywords

  • Exertional Oxygen
  • Ambulatory Oxygen
  • Interstitial Lung Disease

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 Alberta on 2026-07-09.