Can Muscle Dysfunction in COPD be Altered by Oxygenation in Patients With Intermittent Hypoxia on Exertion?
Overview
- Phase
- Phase 4
- Intervention
- Medical air equivalent
- Conditions
- COPD
- Sponsor
- University of Birmingham
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- Gene expression pattern change between interventions in skeletal muscle biopsy
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
Patients with chronic obstructive pulmonary disease (COPD) may develop low oxygen levels, because of damage to their lungs. Long term oxygen therapy (LTOT) is given for at least 15 hours per day, and has established indications and benefits in COPD. However, the indications for and benefits from ambulatory oxygen supplementation (oxygen just when walking or exercising) are less well understood, in part due to heterogeneity of previous study designs, and lack of long term follow up. This is a pilot study of supplementary ambulatory oxygen in COPD, which allows us to ascertain mechanisms of disease by measuring their degree of systemic inflammation pre and post oxygen supplementation, and measuring changes in gene expression in muscles by means of microarray profiling. Secondly, our study will utilise follow up of clinical parameters including home activity monitoring to ascertain medium/long term benefits of oxygen supplementation in a real life setting. Our hypothesis is that exertional hypoxia results in muscle dysfunction and this could be prevented by oxygenation.
Investigators
Alice Turner
Dr
University of Birmingham
Eligibility Criteria
Inclusion Criteria
- •clinical diagnosis of COPD
- •desaturation on exertion
Exclusion Criteria
- •using LTOT
- •immobile for other reason than COPD
Arms & Interventions
Medical air equivalent
Oxygen-nitrogen mix equivalent to medical air when inhaled from a cylinder at 2l/min
Intervention: Medical air equivalent
Oxygen
Ambulatory oxygen delivered at 2l/min on any activity performed by the patient, using a blinded cylinder
Intervention: Oxygen
Outcomes
Primary Outcomes
Gene expression pattern change between interventions in skeletal muscle biopsy
Time Frame: 12 weeks
Secondary Outcomes
- Six minute walk test distance(12 weeks)
- Home activity level as measured by Actigraph(6 and 12 weeks)