Pursed Lip Breathing (PLB) and its role in the management of breathlessness in stable chronic obstructive pulmonary disease (COPD)
| ISRCTN | ISRCTN83029560 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN83029560 |
| Secondary identifying numbers | N0277185567 |
- Submission date
- 28/09/2007
- Registration date
- 28/09/2007
- Last edited
- 27/09/2012
- 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
Mrs Suzanne E Roberts
Scientific
Scientific
Whittington Hospital NHS Trust
Dept of Physiotherapy
The Whittingotn Hospital
Magdala Avenue
London
N19 5NF
United Kingdom
| Phone | +44 020 7288 5660 |
|---|---|
| suzanne.Roberts@whittington.nhs.uk |
Study information
| Study design | Randomised, controlled, single blind study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | |
| Study objectives | Does pursed lip breathing improve quality of life in patients with stable Chronic Obstructive Pulmonary Disease, in whom activities of daily living are limited by breathlessness? |
| Ethics approval(s) | Added July 2008: Moorfields and Whittington Local Research Ethics Committee, 05/Q0504/93, favourable opinion granted 08/02/06. |
| Health condition(s) or problem(s) studied | Respiratory: Chronic obstructive pulmonary disease (COPD) |
| Intervention | Pursed Lip Breathing (PLB) vs control |
| Intervention type | Other |
| Primary outcome measure | Added July 2008: 1. Chronic Respiratory Disease Questionnaire 2. Endurance Shuttle Walk Test |
| Secondary outcome measures | Added July 2008: 1. Borg Dyspnoea Scale 2. Respiratory rate and inspiratory capacity pre and post exercise 3. Hospital Anxiety and Depression scale |
| Overall study start date | 01/03/2006 |
| Completion date | 01/03/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | Prior to July 2008: 86. As of July 2008: 46 |
| Key inclusion criteria | Prior to July 2008: 1. Non smoking patients that have been diagnosed with COPD who are in a stable condition. 2. 86 participants, broken down as approximately 4/5th will be recruited from The Whittington NHS and 1/5th from Islington PCT. Modified July 2008: 1. Diagnosis of COPD (FEV1 < 80% and FEV1/FVC < 70% predicted) 2. Medical intervention optimised according to NICE guidelines 3. MRC 3 or more; as a minimum walks slower than contemporaries on level ground or has to stop for breathing when walking at own pace 4. 4/52 since last exacerbation and 6/52 since last admission 5.Informed consent obtained and signed after provision of information sheet 6. Able to comply with study procedure |
| Key exclusion criteria | Added July 2008: 1. Subject requires an interpreter for consent form 2. Mini-mental test score < 24 (performed in English) 3. Subject has no fixed abode or does not consent to home visits 4. Hospital Lone Practioner Policy precludes home visits to this subject 5. Previously taught PLB 6. On long term oxygen therapy (LTOT) 7. Medical history preventing ability to walk (other than COPD) 8. Ex-smoker of < 3 months 9. Unstable Angina 10. Uncontrolled hypertension 11. Uncontrolled congestive cardiac failure 12. Uncontrolled cardiac arrhythmias 13. Myocardial infarct within 6 weeks |
| Date of first enrolment | 01/03/2006 |
| Date of final enrolment | 01/03/2009 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Whittington Hospital NHS Trust
London
N19 5NF
United Kingdom
N19 5NF
United Kingdom
Sponsor information
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Government
Government
The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
Whittington Hospital NHS Trust (UK)
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 | 01/12/2011 | Yes | No |
