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Completed

NCT Number: NCT01722370

Ambulatory Oxygen Effects on Muscles in COPD

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Heart of England NHS Foundation Trust

Birmingham, West Midlands, B9 5SS, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • clinical diagnosis of COPD
  • desaturation on exertion

Exclusion criteria

  • using LTOT
  • immobile for other reason than COPD

Treatment and study plan

Oxygen

Drug

Medical air equivalent

Drug

Primary outcomes

  1. Gene expression pattern change between interventions in skeletal muscle biopsy

    Time frame: 12 weeks

Secondary outcomes

  1. Six minute walk test distance

    Time frame: 12 weeks

  2. Home activity level as measured by Actigraph

    Time frame: 6 and 12 weeks

Other outcomes

  1. Blood gases

    Time frame: 12 weeks

  2. Quality of life

    Time frame: 6 and 12 weeks

  3. Anxiety and depression score

    Time frame: 12 weeks

  4. Arterial stiffness

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

University of Birmingham

Other

Collaborators

  • Heart of England NHS Trust

Registry information

Official study title

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

Acronym: OM-COPD

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Nov 6, 2012
Registry last updated
Dec 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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