Breathing and relaxation exercises for adult patients diagnosed with asthma in primary care: a randomised controlled trial
ISRCTN | ISRCTN47120289 |
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DOI | https://doi.org/10.1186/ISRCTN47120289 |
ClinicalTrials.gov number | NCT00400270 |
Secondary identifying numbers | N/A |
- Submission date
- 21/11/2006
- Registration date
- 06/12/2006
- Last edited
- 14/11/2022
- 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 Elizabeth A Holloway
Scientific
Scientific
University College London
Department of Epidemiology and Public Health
Gower Street Campus
1-19 Torrington Place
London
WC1E 6BT
United Kingdom
Phone | +44 (0)14 3823 5693 |
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annrobson@ntlworld.com |
Study information
Study design | Randomised controlled trial with an intervention and control arm. Twelve month follow-up. Open label - as this is a therapy trial. |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Treatment |
Scientific title | Breathing and relaxation exercises for adult patients diagnosed with asthma in primary care: a randomised controlled trial |
Study objectives | 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(s) | Hertfordshire Local Research Ethics Committee. Approval granted September 2004 (reference number: EC03660) |
Health condition(s) or problem(s) studied | 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 |
Primary outcome measure | 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 study start date | 01/10/2004 |
Completion date | 01/02/2006 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Both |
Target number of participants | 56 |
Total final enrolment | 85 |
Key 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 |
Key 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.,) |
Date of first enrolment | 01/10/2004 |
Date of final enrolment | 01/02/2006 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
University College London
London
WC1E 6BT
United Kingdom
WC1E 6BT
United Kingdom
Sponsor information
University College London (UK)
University/education
University/education
Department of Epidemiology and Public Health
London
WC1E 6BT
England
United Kingdom
Website | http://www.ucl.ac.uk/ |
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https://ror.org/02jx3x895 |
Funders
Funder type
University/education
University College London
Government organisation / Universities (academic only)
Government organisation / Universities (academic only)
- Alternative name(s)
- University College London in United Kingdom, Collegium Universitatis Londinensis, UCL
- Location
- United Kingdom
Results and Publications
Intention to publish date | |
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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 | Not provided at time of registration |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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Results article | 01/12/2007 | Yes | No |
Editorial Notes
14/11/2022: Total final enrolment added.