Does oxygen when walking help to prevent muscle disease in patients with chronic obstructive pulmonary disease?

Can muscle dysfunction in COPD be altered by oxygenation in patients with intermittent hypoxia on exertion? - Use of ambulatory oxygen in COPD

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-003595-36-GB

Enrollment

Registered

2012-04-26

Start date

2012-04-26

Completion date

Unknown

Last updated

2015-08-04

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

Conditions

Chronic obstructive pulmonary disease

Interventions

Trade Name: Medical oxygen (compressed) Product Name: Medical oxygen (compressed) Product Code: PL0735/5000R Pharmaceutical Form: Medicinal gas, compressed INN or Proposed INN: Medicinal oxygen Ph Eur

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Spirometry: post bronchodilator FEV1/FVC 7.3KPa or >8KPa if co-existent cor pulmonale Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 15 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 15

Exclusion criteria

Exclusion criteria: 1) Immobile due to other medical conditions 2) On LTOT 3) Unable to understand or retain information 4) Uncontrolled anginal symptoms 5) Evidence of potential harm from oxygen supplementation on previous capillary gases or dejours test - specifically a rise in CO2 after being given oxygen that is of a clinically significant magnitude

Design outcomes

Primary

Measure	Time frame
Main Objective: Our primary question is whether changes in muscle structure including gene expression occur during normal daily life in patients with COPD that can be corrected by giving oxygen. To do this we will compare the appearance of and genes expressed in muscle of patients after they have received oxygen and after they have been given air to use at home for 12 weeks.;Secondary Objective: We are interested in how changes in muscles and other pathology of COPD is affected by oxygen, and how this impacts on patients lives. We will therefore measure inflammation in the circulation, store blood for gene expression analysis (to be used only if muscle analyses fail), measure quality of life (CAT questionnaire), assess mental health (HADS questionnaire), measure circulatory function (arterial stiffness), assess activity level at home (Actigraph monitor) and assess walking distance (6 minute walk test). These factors will be compared between patients when they take oxygen and when they take air at home.;Primary end point(s): Change in gene expression patterns between baseline and end of oxygen treatment, as compared to change from baseline to end of medical air;Timepoint(s) of evaluation of this end point: 12 weeks from start of intervention, which is either active (oxygen) or placebo (air)	—

Measure

Time frame

Main Objective: Our primary question is whether changes in muscle structure including gene expression occur during normal daily life in patients with COPD that can be corrected by giving oxygen. To do this we will compare the appearance of and genes expressed in muscle of patients after they have received oxygen and after they have been given air to use at home for 12 weeks.;Secondary Objective: We are interested in how changes in muscles and other pathology of COPD is affected by oxygen, and how this impacts on patients lives. We will therefore measure inflammation in the circulation, store blood for gene expression analysis (to be used only if muscle analyses fail), measure quality of life (CAT questionnaire), assess mental health (HADS questionnaire), measure circulatory function (arterial stiffness), assess activity level at home (Actigraph monitor) and assess walking distance (6 minute walk test). These factors will be compared between patients when they take oxygen and when they take air at home.;Primary end point(s): Change in gene expression patterns between baseline and end of oxygen treatment, as compared to change from baseline to end of medical air;Timepoint(s) of evaluation of this end point: 12 weeks from start of intervention, which is either active (oxygen) or placebo (air)

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Secondary

Measure	Time frame
Secondary end point(s): Quality of life (CAT score), 6 minute walk test distance, level of depression and/or anxiety (HADS), lung function (spirometry), home activity level (Actigraph), blood markers of oxidative stress and inflammation, arterial stiffness, respiratory sensitivity;Timepoint(s) of evaluation of this end point: The flowchart within the protocol demonstrates these: for the most part all secondary outcome data is collected at the same time as muscle biopsy data, with the exception of quality of life and home activity which is also checked at the mid point of each treatment i.e. 6 weeks into either active or placebo treatment	—

Measure

Time frame

Secondary end point(s): Quality of life (CAT score), 6 minute walk test distance, level of depression and/or anxiety (HADS), lung function (spirometry), home activity level (Actigraph), blood markers of oxidative stress and inflammation, arterial stiffness, respiratory sensitivity;Timepoint(s) of evaluation of this end point: The flowchart within the protocol demonstrates these: for the most part all secondary outcome data is collected at the same time as muscle biopsy data, with the exception of quality of life and home activity which is also checked at the mid point of each treatment i.e. 6 weeks into either active or placebo treatment

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Countries

United Kingdom

Contacts

Public ContactAlice Wood

University of Birmingham

a.m.wood@bham.ac.uk01213713226

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026