| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN47120289 |
| Date ISRCTN assigned | 06/12/2006 |
| Local reference number(s) | N/A |
| Public title | Breathing and relaxation exercises for adult patients diagnosed with asthma in primary care: a randomised controlled trial |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Asthma |
| 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). |
| Design/methodology | Randomised controlled trial with an intervention and control arm. Twelve month follow-up. Open label - as this is a therapy trial. |
| Research ethics review | Hertfordshire Local Research Ethics Committee. Approval granted September 2004 (reference number: EC03660). |
| Countries of trial | United Kingdom |
| Participants - 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 |
| Participants - 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.,) |
| Patient information material |
|
| Anticipated start date | 01/10/2004 |
| Anticipated end date | 01/02/2006 |
| Status of trial | Completed |
| Target number of participants | 56 |
| Interventions | 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. |
| Primary outcome measure(s) | 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 measure(s) | 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. |
| Publications | Results in:
1. http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=retrieve&db=pubmed&list_uids=17573445&dopt=Abstract |
| Sources of funding | This study was undertaken as part fulfillment of a PhD at University College London and as such was supported by University College London (UK) |
| Sponsor name | University College London (UK) |
| Sponsor details | Department of Epidemiology and Public Health
London
United Kingdom
WC1E 6BT |
| Sponsor website | http://www.ucl.ac.uk/ |
| Contact name | Mrs Elizabeth A Holloway |
| Contact details | University College London
Department of Epidemiology and Public Health
Gower Street Campus
1-19 Torrington Place
London
United Kingdom
WC1E 6BT |
| Contact telephone | +44 (0)14 3823 5693 |
| Contact fax | +44 (0)20 7813 0242 |
| Contact email | annrobson@ntlworld.com |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN47120289 |
| Date last extracted from ISRCTN register | 17/04/2008 |
