Condition category
Respiratory
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
17/09/2012
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

Ms Lorna Johnson

ORCID ID

Contact details

King's College Hospital Medical School
Kensington Campus
Camden Hill Road
London
W8 7AH
United Kingdom
+44 (0)20 7737 4000
lorna.johnson@kcl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

RDC01621

Study information

Scientific title

Acronym

Study hypothesis

The aim of this study is to investigate the effects of the POWERbreathe on respiratory muscle strength and endurance in people with COPD and also to assess the effects of IMT on breathlessness, functional exercise capacity and quality of life. The results of this study will provide evidence to enable healthcare professionals to advise their patients about the value of this device and may support the introduction of this or similar devices as a therapy for people with COPD.

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

Chronic obstructive pulmonary disease

Intervention

Not provided at time of registration

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Mean changes in respiratory muscle strength (cms H2O), respiratory muscle endurance (peak power [cms H2O] and duration [seconds]), shuttle walk distance (metres), Borg scores for breathlessness and CRDQ will be compared between groups using an unpaired t-test or analysis of covariance. Any changes in respiratory muscle strength and endurance will be compared with changes in shuttle walk distance and CRDQ scores using correlation.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/03/2000

Overall trial end date

01/03/2002

Reason abandoned

Eligibility

Participant inclusion criteria

1. 80 non-hypercapnic patients with moderate (forced expiratory volume [FEV] <40%) will be recruited from consultant hospital and community chest clinics.
2. All patients will be receiving optimum medical management and will have been stable for at least 4 weeks prior to their initial assessment.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

80

Participant exclusion criteria

1. Hypercapnia (PaCO2 >45 mmHg)
2. Any patient who is unsuitable for magnetic stimulation (pacemakers, artificial heart valves, metal prosthesis).

Recruitment start date

01/03/2000

Recruitment end date

01/03/2002

Locations

Countries of recruitment

United Kingdom

Trial participating centre

King's College Hospital Medical School
London
W8 7AH
United Kingdom

Sponsor information

Organisation

NHS R&D Regional Programme Register - Department of Health (UK)

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

NHS Executive London (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

1. 2003 results in D Nikoletou, J A Backley, J Gearing, W D C Man, N Mustfa, L C Johnson, J Moxham (2003) 'A double-blind, randomised controlled trial of inspiratory muscle training in COPD patients', Winter Meeting of the British Thoracic-Society LONDON, ENGLAND, pp. 77-77.
[Meeting Abstract in Journal (Print)]

Publication citations

Additional files

Editorial Notes