Ambulatory oxygen improves the effectiveness of pulmonary rehabilitation in selected patients

ISRCTN	ISRCTN22894945
DOI	https://doi.org/10.1186/ISRCTN22894945
Protocol serial number	TC08/5
Sponsor	Surrey Community Health (UK)
Funders	Surrey Community Health (UK), British Lung Foundation (UK) - Trevor Clay Memorial Fund research grant

Submission date: 26/04/2010
Registration date: 13/05/2010
Last edited: 29/07/2013

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Respiratory

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Ms Julia Bott
Scientific

The Respiratory Care Team
C/o Bournewood House
Guildford Road
Chertsey
KT16 0QA
United Kingdom

Study information

Primary study design	Interventional
Study design	Prospective multicentre single blind randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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
Study objectives	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(s)	Surrey Ethics Committee approved on the 7th August 2007 (ref: 07/H1109/89)
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Exercise tolerance measured using the Endurance Shuttle Walk Test pre- and post-pulmonary rehabilitation
Key secondary outcome measure(s)	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.
Completion date	30/09/2009

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	52
Key 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.
Key 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
Date of first enrolment	01/09/2007
Date of final enrolment	30/09/2009

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

The Respiratory Care Team

Chertsey
KT16 0QA
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/05/2012		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes