Condition category
Respiratory
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
18/02/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr RK McKinley

ORCID ID

Contact details

University Hospitals of Leicester
c/o Research and Development Office
Leicester General Hospital NHS Trust
Leicester
LE1 4PW
United Kingdom
+44 0)116 258 4109
nicola.turner@uhl-tr.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0123119545

Study information

Scientific title

Acronym

Study hypothesis

1. To investigate the effects of breathing retraining supervised by a respiratory physiotherapist on clinical and physiological measures of asthma control
2. To identify the characteristics of patients who may benefit from this intervention
3. To perform a health economical evaluation of the intervention

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Asthma

Intervention

Breathing retraining supervised by a respiratory physiotherapist compared to an attention control of generic asthma education provided by a nurse.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Asthma related quality of life (Juniper AQLQ)
2. Generic quality of life (Euroquol)
3. Asthma control (Juniper ACQ)
4. Nijmegen Questionnaire
5. Hospital Anxiety and Depression
6. Bronchial hyper-responsiveness (methacholine PC20)
7. Sputum eosinophil counts
8. Exhaled nitric oxide concentrations
9. Capnography
10. Hyperventilation studies

Measured before and 1 month after the intervention and control procedures. The questionnaires will be re-administered 6 and 12 months following the completion of intervention.

Secondary outcome measures

No secondary outcome measures

Overall trial start date

01/06/2002

Overall trial end date

31/08/2004

Reason abandoned

Eligibility

Participant inclusion criteria

1. Family practice patientsÂ’ aged 18 - 65 years
2. A diagnosis of asthma
3. Received at least one asthma prescription in the previous year
4. With and without symptoms of dysfunctional breathing

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

212

Participant exclusion criteria

Does not comply with above inclusion criteria

Recruitment start date

01/06/2002

Recruitment end date

31/08/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University Hospitals of Leicester
Leicester
LE1 4PW
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Charity

Funder name

National Asthma Campaign (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

2009 results in: http://www.ncbi.nlm.nih.gov/pubmed/19052047

Publication citations

  1. Results

    Thomas M, McKinley RK, Mellor S, Watkin G, Holloway E, Scullion J, Shaw DE, Wardlaw A, Price D, Pavord I, Breathing exercises for asthma: a randomised controlled trial., Thorax, 2009, 64, 1, 55-61, doi: 10.1136/thx.2008.100867.

Additional files

Editorial Notes