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Does an 8 week course of Ambulatory Oxygen Increase Diffuse Parenchymal Lung Diseases Patients Ability to Perform a 6 Minute Walk Test and/or Improve Patients Perception of Quality of Life as measured by the Short Form 36-Item Questionnaire to Measure Health Related Quality of Life.

Does an 8 week course of Ambulatory Oxygen Increase Diffuse Parenchymal Lung Diseases Patients Ability to Perform a 6 Minute Walk Test and/or Improve Patients Perception of Quality of Life as measured by the Short Form 36-Item Questionnaire to Measure Health Related Quality of Life.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2007-001889-33-GB
Enrollment
Unknown
Registered
2007-06-26
Start date
2007-08-24
Completion date
Unknown
Last updated
2012-07-03

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

Conditions

Patients enrolled will have a diagnosis of restrictive lung disease diagnosed by a High Resolution CT scan, reduced gas transfer result (obtained from pulmonary function tests) and low lung volumes (obtained from pulmonary function tests). MedDRA version: 9.1 Level: LLT Classification code 10033318 Term: Oxygen saturation decreased MedDRA version: 9.1 Level: LLT Classification code 10050322 Term: Oxygen supplementation

Interventions

Trade Name: Medical Oxygen Product Name: BOC Oxygen Cylinder PD 300Lts 99.5% Product Code: 0735/5000 Pharmaceutical Form: Inhalation gas

Sponsors

North Bristol NHS Trust
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - Patients must have a CT confirmed diagnosis of restrictive lung disease as this is the current standard for diagnosing these disorders. - Patients must have an abnormal gas transfer PFT as this is confirmation of the extent of damage to the patients lungs. - Patients must be mobile as this is neccessary to complete a 6 minute walk test. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Patients who are not mobile, as they need to complete a six minute walk test. - Patients with poor comprehension, as they will not understand the instructions. - Patients who would be unable to carry or push around an oxygen cylinder. - Patients who are already prescribed long term oxygen therapy.

Design outcomes

Primary

MeasureTime frame
Main Objective: The aim is to examine if patients walking distance change, measured by a 6 minute walk test, and/or perceive their symptoms to change, measured using a quality of life questionnaire after an 8 week course of ambulatory oxygen compared to a group of patients with the same disease that don't receive oxygen.;Secondary Objective: Quality of life measurements associated with this treatment measured using the validated SF-36 quality of life questionnaire.;Primary end point(s): The aim of this study is to investigate the benefit of an 8 week course of ambulatory oxygen on patients with DPLD, both physiologically, measured using a 6 minute walk test, and psychologically, using a quality of life score. Any change in the distance walked during the 6 minute walk test both pre and post oxygen trial, and any change in teh quality of life score will be examined.

Countries

United Kingdom

Outcome results

None listed

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