Breathing and relaxation exercises for adult patients diagnosed with asthma in primary care: a randomised controlled trial

ISRCTN	ISRCTN47120289
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

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
Email	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.
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
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

Sponsor information

University College London (UK)
University/education

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

Website	http://www.ucl.ac.uk/
"ROR"	https://ror.org/02jx3x895

Funders

Funder type

University/education

University College London
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
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?
Results article		01/12/2007		Yes	No

Editorial Notes

14/11/2022: Total final enrolment added.