None listed
Conditions
Brief summary
Idiopathic pulmonary fibrosis (IPF) is a progressive and disabling lung disease characterized by significant dyspnoea and fatigue, reduced exercise tolerance and has a poor prognosis. Oxidative stress is a prominent feature of IPF, which is increased during exercise. This increased oxidant burden during exercise is accompanied by hypoxemia and an impaired metabolic response which may contribute to skeletal muscle dysfunction and limit exercise endurance in patients with IPF. Currently there is no evidence regarding the effect of supplemental oxygen on exercise induced oxidative stress in patients with IPF, despite several studies showing promising outcomes in patients with COPD . The primary aim of this study is to identify whether supplemental oxygen is successful in reducing exercise induced oxidative stress in IPF and whether it plays a role in attenuating impaired skeletal muscle metabolism leading to an improvement in exercise tolerance.
Interventions
Participants will be randomised to receive either supplemental oxygen or compressed air for one hour at rest then they will subsequently perform a constant cycle endurance test at 85% of the peak work rate achieved on a cardiopulmonary exercise test receiving the same intervention (oxygen or air). One week later participants will repeat the protocol, receiving the opposite intervention to their previous visit.
Oxygen supplementation and compressed air will be supplied at rest and during exerci
Participants will be randomised to receive either supplemental oxygen or compressed air for one hour at rest then they will subsequently perform a constant cycle endurance test at 85% of the peak work rate achieved on a cardiopulmonary exercise test receiving the same intervention (oxygen or air). One week later participants will repeat the protocol, receiving the opposite intervention to their previous visit. Oxygen supplementation and compressed air will be supplied at rest and during exercise via a venturi mask. Oxygen will be supplied at a FiO2 of 0.30. The mask and gas flow will be set up by an unblinded investigator and the oxygen and air flow meters will be screened so that the researcher conducting the exercise tests is unaware of the gas allocation. This investigator will also monitor SpO2 throughout the test and will notify the researcher conducting the test if SpO2 drops below 80%.
Sponsors
Leona Dowman
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Prevention
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
30 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
Patients with a documented diagnosis of idiopathic pulmonary fibrosis
Exclusion criteria
Patients who 1. are clinically unstable 2. have a history of syncope on exertion 3. have a concurrent and predominant diagnosis of another significant respiratory disorder (e.g. non-IPF interstitial lung disease, asthma, chronic obstructive pulmonary disease [COPD], bronchiectasis, cystic fibrosis, or lung carcinoma) 4. have any significant co-morbidities which preclude exercise or would prevent them from completing the exercise test protocol. 5. have a resting SpO2 less than or equal to 85% on room air
Outcome results
None listed