Condition category
Respiratory
Date applied
21/11/2006
Date assigned
06/12/2006
Last edited
25/06/2007
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 Elizabeth A Holloway

ORCID ID

Contact details

University College London
Department of Epidemiology and Public Health
Gower Street Campus
1-19 Torrington Place
London
WC1E 6BT
United Kingdom
+44 (0)14 3823 5693
annrobson@ntlworld.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00400270

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

Asthma is of global concern and prevalence, thus morbidity and expenditure are increasing. Orthodox medical treatment focuses primarily on pharmaceutical control and education concerning its administration; patients are reported as seeking complementary and alternative therapies wishing to self-manage their condition. The majority of patients are being managed in primary care settings.

Chartered physiotherapists, since the 1960s, have been referred patients with asthma and breathing dysfunction for treatment with the Papworth Method (PM). Patients report improved quality of life but there is little evidence, including from Cochrane reviews, to support the use of breathing and relaxation therapies.

Therefore hypotheses for this trial are that:
1. A specific physical therapy intervention, comprising integrated breathing and relaxation exercises, the Papworth Method (PM), will improve the quality of life for adult asthma patients, already receiving usual medical care, in a primary care population.
2. Anxiety and depression will reduce in this population of patients diagnosed with asthma when treated with the PM.
3. Symptoms from dysfunctional breathing will reduce in this population after treatment with the PM.
4. Respiratory measures will improve (although this study is powered for quality of life and not respiratory function outcomes).

Ethics approval

Hertfordshire Local Research Ethics Committee. Approval granted September 2004 (reference number: EC03660).

Study design

Randomised controlled trial with an intervention and control arm. Twelve month follow-up. Open label - as this is a therapy trial.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Asthma

Intervention

Integrated breathing and relaxation exercises known as the Papworth Method (PM). These techniques originated and were developed by physiotherapists in the Respiratory Medicine Department of Papworth Hospital, Cambridgeshire, UK in the 1960s.

The five, 60 minute treatments were undertaken by a respiratory physiotherapist in the intervention group between the baseline and six month assessments.

Patients in the control and intervention groups received usual asthma care. The comparisons were between normal care only (the control group) and the intervention group receiving five PM treatments at six months (or post-treatment) and at 12 months post baseline.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Health related quality of life, as measured by the validated St George’s Respiratory Questionnaire with three domains (symptoms, activities and impacts) and a total overall score.

Secondary outcome measures

1. Anxiety and Depression as measured by the validated Hospital Anxiety and Depression Scale.
2. Symptoms from dysfunctional breathing as measured by the validated Nijmegen Questionnaire.
3. Respiratory measures as measured by spirometry and capnography.

Overall trial start date

01/10/2004

Overall trial end date

01/02/2006

Reason abandoned

Eligibility

Participant inclusion criteria

1. Men and women between 16 and 70 years of age
2. 'Doctor' diagnosed asthma volunteers, recruited from the asthma database of one primary care practice
3. Able to understand, read and write English
4. Willing to give written informed consent
5. Willing and able to attend the local surgery for required number of attendances

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

56

Participant exclusion criteria

Serious co-morbid conditions such as hemiplegia (we aimed to recruit patients typical of the caseload of any semi-rural population of primary care asthma patients in order that this study should be generalisable to similar practices. For the same reason we did not require confirmation of a diagnosis of asthma by reversibility etc.,)

Recruitment start date

01/10/2004

Recruitment end date

01/02/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University College London
London
WC1E 6BT
United Kingdom

Sponsor information

Organisation

University College London (UK)

Sponsor details

Department of Epidemiology and Public Health
London
WC1E 6BT
United Kingdom

Sponsor type

University/education

Website

http://www.ucl.ac.uk/

Funders

Funder type

University/education

Funder name

This study was undertaken as part fulfillment of a PhD at University College London and as such was supported by University College London (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

Results in:
1. http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=retrieve&db=pubmed&list_uids=17573445&dopt=Abstract

Publication citations

  1. Holloway EA, West RJ, Integrated breathing and relaxation training (the Papworth method) for adults with asthma in primary care: a randomised controlled trial., Thorax, 2007, 62, 12, 1039-1042, doi: 10.1136/thx.2006.076430.

Additional files

Editorial Notes