Inspiratory muscle training in patients with Chronic Obstructive Pulmonary Disease (COPD)

ISRCTN	ISRCTN19258620
DOI	https://doi.org/10.1186/ISRCTN19258620
Secondary identifying numbers	RDC01621

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Ms Lorna Johnson
Scientific

King's College Hospital Medical School
Kensington Campus
Camden Hill Road
London
W8 7AH
United Kingdom

Phone	+44 (0)20 7737 4000
Email	lorna.johnson@kcl.ac.uk

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Chronic obstructive pulmonary disease
Intervention	Not provided at time of registration
Intervention type	Other
Primary outcome measure	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 study start date	01/03/2000
Completion date	01/03/2002

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	80
Key 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.
Key exclusion criteria	1. Hypercapnia (PaCO2 >45 mmHg) 2. Any patient who is unsuitable for magnetic stimulation (pacemakers, artificial heart valves, metal prosthesis).
Date of first enrolment	01/03/2000
Date of final enrolment	01/03/2002

King's College Hospital Medical School

London
W8 7AH
United Kingdom

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

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Government

NHS Executive London (UK)

No information available

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

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Abstract results		01/12/2003		No	No