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Oxygen with exercise in idiopathic interstitial pneumonia

In patients with idiopathic interstitial pneumonia, giving supplemental oxygen during exercise improves endurance and pulmonary haemodynamics

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12611001285943
Enrollment
18
Registered
2011-12-15
Start date
2012-09-10
Completion date
2016-04-20
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This is a study looking at exercise physiology in people with lung fibrosis. In particular, investigators are interested in the role of oxygen in exercise endurance, maximal exercise levels, and in its effect on reducing strain on the heart. Participants will perform endurance exercise tests and maximal exercise testing on both air and oxygen. The hypothesis is that oxygen will improve endurance and reduce strain on the heart. This study will form the basis for future trials that examine the benefits of supplemental oxygen over longer periods.

Interventions

Supplemental oxygen either 35% through a venturi mask, or 60% through a breathing circuit. A venturi mask, also known as an air-entrainment mask, is a medical device worn over the mouth and nose, that delivers a known oxygen concentration to patients. It is attached via long tubing to an oxygen cylinder during the endurance shuttle walk testing. The breathing circuit is routinely used in cardiopulmonary exercise testing on a stationary bike, allowing investigators to measure oxygen uptake and

Supplemental oxygen either 35% through a venturi mask, or 60% through a breathing circuit. A venturi mask, also known as an air-entrainment mask, is a medical device worn over the mouth and nose, that delivers a known oxygen concentration to patients. It is attached via long tubing to an oxygen cylinder during the endurance shuttle walk testing. The breathing circuit is routinely used in cardiopulmonary exercise testing on a stationary bike, allowing investigators to measure oxygen uptake and expired carbon dioxide. It is also a convenient way of delivering supplemental oxygen during such testing. It has a mouthpiece much like scuba diving apparatus and is secured to the patient via a support frame over the head. These two devices will only be worn during the exercise tests, (10 to 30 minutes in duration). As per trial protocol, this is a crossover study, where each individual will perform 2 endurance shuttle walk tests (1 on oxygen via venturi mask, the other on air (sham) via venturi mask). The same individuals will also perform 2 maximal exercise tests on a stationary bike (1 on oxygen via breathing circuit, the other on air (sham) via breathing circuit). Crossover from intervention to placebo or vice versa will occur not less than 24 hours apart, and not greater than 28days apart. The washout period required for supplemental oxygen is only 15 to 20 minutes, but the 24 hours between testing is to allow complete recovery from the exercise itself.

Sponsors

Royal Prince Alfred Hospital
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Prevention
Masking
Blinded (masking used)

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

Patients 18 - 80 yrs. Patients able to perform exercise test as determined following clinical assessment. Patients who desaturate to < 88% during a 6 minute walk test (6MWT) Patients able to give informed consent. Patients with idiopathic interstitial pneumonia (IIP), according to American Thoracic Society /European Respiratory Society criteria. Absence of daytime resting hypoxaemia (ie with PaO2 > 55mmHg).

Exclusion criteria

Patients not able to give informed consent. Patients considered unable to complete exercise test by their physician. Presence of daytime resting hypoxaemia (PaO2 less than or equal to 55mmHg). Presence of hypercapnia (PaCO2 > 45mmHg) at baseline Patients with absolute contraindications to exercise testing including: Aortic aneursym Current viral illness Unstable angina/acute ECG changes of ischaemia. Myocardial infarction within the last 4 weeks. Severe hypertension (systolic >240 mmHg; diastolic >120 mmHg). Poorly controlled heart failure. Myocarditis. Exacerbation of asthma. Severe aortic stenosis. Acute pulmonary embolus / thrombus / venous thromboembolic disorders. Pulmonary oedema. Mental Impairment

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026