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 Georges 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
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
-
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.