Ambulatory Oxygen Therapy for Individuals With Mild-to-moderate Interstitial Lung Disease

ConditionFibrotic Interstitial Lung Disease

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18-85

SponsorUniversity of Alberta

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

Exertional Oxygen
Drug
Use of a portable oxygen concentrator for exertional activities lasting \>2 minutes
Education and Support
Behavioral
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.

Treatment groups

60 Participants

are divided into 3 treatment groups

Group A: Arm 1 - Usual CareNo intervention 0 interventions

Group B: Arm 2 - Exertional OxygenExperimental treatment 1 intervention

Group C: Arm 3 - Exertional Oxygen + SupportExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

Feasibility of investigation

Number of patients recruited and completing the protocol in each arm

Time frame

2 years

Exercise tolerance

6 minute walk distance

Time frame