Ambulatory Oxygen Effects on Muscles in COPD

Can Muscle Dysfunction in COPD be Altered by Oxygenation in Patients With Intermittent Hypoxia on Exertion?

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01722370

Acronym

OM-COPD

Enrollment

Registered

2012-11-06

Start date

2012-08-31

Completion date

2014-11-30

Last updated

2014-12-03

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

Conditions

COPD

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.

Interventions

DRUGOxygen

DRUGMedical air equivalent

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* clinical diagnosis of COPD * desaturation on exertion

Exclusion criteria

* using LTOT * immobile for other reason than COPD

Design outcomes

Primary

Measure	Time frame
Gene expression pattern change between interventions in skeletal muscle biopsy	12 weeks

Secondary

Measure	Time frame
Six minute walk test distance	12 weeks
Home activity level as measured by Actigraph	6 and 12 weeks

Other

Measure	Time frame
Blood gases	12 weeks
Arterial stiffness	12 weeks
Quality of life	6 and 12 weeks
Anxiety and depression score	12 weeks

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026