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 designRandomised controlled trial with an intervention and control arm. Twelve month follow-up. Open label - as this is a therapy trial.
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific titleBreathing and relaxation exercises for adult patients diagnosed with asthma in primary care: a randomised controlled trial
Study objectivesAsthma 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) studiedAsthma
InterventionIntegrated 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 typeOther
Primary outcome measure1. 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 measures1. 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 date01/10/2004
Completion date01/02/2006

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants56
Total final enrolment85
Key inclusion criteria1. 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 criteriaSerious 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 enrolment01/10/2004
Date of final enrolment01/02/2006

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 logo "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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing planNot 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.