Condition category
Respiratory
Date applied
28/09/2007
Date assigned
28/09/2007
Last edited
27/09/2012
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

Mrs Suzanne E Roberts

ORCID ID

Contact details

Whittington Hospital NHS Trust
Dept of Physiotherapy
The Whittingotn Hospital
Magdala Avenue
London
N19 5NF
United Kingdom
+44 020 7288 5660
suzanne.Roberts@whittington.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0277185567

Study information

Scientific title

Acronym

Study hypothesis

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

Added July 2008:
Moorfields and Whittington Local Research Ethics Committee, 05/Q0504/93, favourable opinion granted 08/02/06.

Study design

Randomised, controlled, single blind study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Respiratory: Chronic obstructive pulmonary disease (COPD)

Intervention

Pursed Lip Breathing (PLB) vs control

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/03/2006

Overall trial end date

01/03/2009

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

Prior to July 2008: 86. As of July 2008: 46

Participant 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

Recruitment start date

01/03/2006

Recruitment end date

01/03/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Whittington Hospital NHS Trust
London
N19 5NF
United Kingdom

Sponsor information

Organisation

Record Provided by the NHSTCT Register - 2007 Update - Department of Health

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

Whittington Hospital NHS Trust (UK)

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

1. 2011 results in http://thorax.bmj.com/content/66/Suppl_4/A175.2.short

Publication citations

Additional files

Editorial Notes