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ISRCTN
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ISRCTN19258620
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ClinicalTrials.gov identifier
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Public title
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Inspiratory muscle training in patients with Chronic Obstructive Pulmonary Disease (COPD)
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Scientific title
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Acronym
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N/A
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Serial number at source
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RDC01621
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Study hypothesis
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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.
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Chronic obstructive pulmonary disease
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Participants - inclusion criteria
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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.
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Participants - exclusion criteria
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1. Hypercapnia (PaCO2 >45 mmHg)
2. Any patient who is unsuitable for magnetic stimulation (pacemakers, artificial heart valves, metal prosthesis).
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Anticipated start date
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01/03/2000
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Anticipated end date
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01/03/2002
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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80
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Interventions
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Not provided at time of registration
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Primary outcome measure(s)
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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.
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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NHS Executive London (UK)
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Trial website
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Publications
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Contact name
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Ms
Lorna
Johnson
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Address
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King's College Hospital Medical School
Kensington Campus
Camden Hill Road
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City/town
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London
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Zip/Postcode
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W8 7AH
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Country
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United Kingdom
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Tel
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+44 (0)20 7737 4000
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Email
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lorna.johnson@kcl.ac.uk
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Sponsor
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NHS R&D Regional Programme Register - Department of Health (UK)
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Address
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The Department of Health
Richmond House
79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)20 7307 2622
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Fax
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+44 (0)20 7307 2623
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.doh.gov.uk
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Date applied
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23/01/2004
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Last edited
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07/01/2010
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Date ISRCTN assigned
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23/01/2004
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