Ambulatory oxygen improves the effectiveness of pulmonary rehabilitation in selected patients
| ISRCTN | ISRCTN22894945 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN22894945 |
| Secondary identifying numbers | TC08/5 |
- 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
Scientific
The Respiratory Care Team
C/o Bournewood House
Guildford Road
Chertsey
KT16 0QA
United Kingdom
Study information
| Study design | Prospective multicentre single blind randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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 study start date | 01/09/2007 |
| Completion date | 30/09/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 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
- England
- United Kingdom
Study participating centre
The Respiratory Care Team
Chertsey
KT16 0QA
United Kingdom
KT16 0QA
United Kingdom
Sponsor information
Surrey Community Health (UK)
Government
Government
c/o Lyn Russell
Bournewood House
Guildford Road
Chertsey
KT16 0QA
United Kingdom
| Website | http://www.surreyhealth.nhs.uk/Pages/default.aspx |
|---|
Funders
Funder type
Charity
Surrey Community Health (UK)
No information available
British Lung Foundation (UK) - Trevor Clay Memorial Fund research grant
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
