Condition category
Respiratory
Date applied
26/04/2010
Date assigned
13/05/2010
Last edited
29/07/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Ms Julia Bott

ORCID ID

Contact details

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

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 measures

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

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

http://www.surreyhealth.nhs.uk/Pages/default.aspx

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

Results - basic reporting

Publication summary

2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22452975

Publication citations

  1. 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.

Additional files

Editorial Notes