Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
TC08/5
Study information
Scientific title
The effectiveness of ambulatory oxygen versus room air during pulmonary rehabilitation in patients who are hypoxaemic on exertion and respond to supplemental oxygen at baseline
Acronym
Study hypothesis
The aims of this prospective randomised controlled trial is to determine whether ambulatory oxygen during pulmonary rehabilitation provides additional benefit, compared with room air, for patients hypoxaemic only on exertion and who respond to supplemental oxygen at baseline. Additionally, to determine whether the degree of acute response to ambulatory oxygen predicted any additional benefit.
Ethics approval
Surrey Ethics Committee approved on the 7th August 2007 (ref: 07/H1109/89)
Study design
Prospective multicentre single blind randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Chronic respiratory disease
Intervention
Patients randomised into two groups:
1. Ambulatory oxygen group exercise within pulmonary rehabilitation and at home using ambulatory oxygen
2. Room air group exercise within pulmonary rehabilitation and at home on room air
Secondary sponsor details:
Trevor Clay Memorial Fund (UK)
British Lung Foundation
73 - 75 Goswell Road
London EC1V 7ER
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Exercise tolerance measured using the Endurance Shuttle Walk Test pre- and post-pulmonary rehabilitation
Secondary outcome measures
1. Quality of life measured using the Self-Report Chronic Respiratory Questionnaire
2. Anxiety and depression measured using the Hospital Anxiety and Depression Scale
3. Function measured using the Surrey Information on Function Tool
All are questionnaires completed pre- and post-pulmonary rehabilitation.
Overall trial start date
01/09/2007
Overall trial end date
30/09/2009
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Patients (aged 50 - 87 years, either sex) with chronic respiratory disease enrolled in pulmonary rehabilitation who have resting saturations greater than 92%, but desaturate by greater than 4% and to less than 90% on exertion and who then walk greater than 10% further with ambulatory oxygen during field exercise testing at baseline.
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
52
Participant exclusion criteria
1. Already on oxygen therapy (long-term or ambulatory)
2. Those who do not desaturate significantly on exertion
3. Those who do desaturate but do not demonstrate benefit using ambulatory oxygen at baseline
Recruitment start date
01/09/2007
Recruitment end date
30/09/2009
Locations
Countries of recruitment
United Kingdom
Trial participating centre
The Respiratory Care Team
Chertsey
KT16 0QA
United Kingdom
Sponsor information
Organisation
Surrey Community Health (UK)
Sponsor details
c/o Lyn Russell
Bournewood House
Guildford Road
Chertsey
KT16 0QA
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Charity
Funder name
Surrey Community Health (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
British Lung Foundation (UK) - Trevor Clay Memorial Fund research grant
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22452975
Publication citations
-
Results
Dyer F, Callaghan J, Cheema K, Bott J, Ambulatory oxygen improves the effectiveness of pulmonary rehabilitation in selected patients with chronic obstructive pulmonary disease., Chron Respir Dis, 2012, 9, 2, 83-91, doi: 10.1177/1479972312438702.