Early Pulmonary Rehabilitation Following Acute COPD Exacerbation - Full Text View

Sponsors and Collaborators:	King's College Hospital NHS Trust British Lung Foundation
Information provided by:	King's College Hospital NHS Trust
ClinicalTrials.gov Identifier:	NCT00557115

Purpose

The principal aim of the study is to evaluate whether attendance at an exercise training and education programme (known as pulmonary rehabilitation) shortly following hospital discharge can lead to a reduction in exacerbations and improvement in exercise capacity and quality of life in patients with chronic obstructive pulmonary disease.

Condition	Intervention	Phase
COPD	Other: Early pulmonary rehabilitation (EPR)	Phase III

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease) Exercise and Physical Fitness Rehabilitation

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title:	Early Pulmonary Rehabilitation (PR) Following Hospitalisation For Acute Exacerbations of Chronic Obstructive Pulmonary Disease (COPD)

Further study details as provided by King's College Hospital NHS Trust:

Primary Outcome Measures:

Non-outpatient COPD related hospital attendance (A+E attendance, inpatient admission or death) [ Time Frame: 3-months ]

Secondary Outcome Measures:

Disease specific quality of life (CRDQ and SGRQ) [ Time Frame: 3 months and 1-year ]
Maximal walking capacity (ISW)and endurance walking capacity (ESW) [ Time Frame: 3-months and 1-year ]
Weight and fat free mass (electrical bioimpedance) [ Time Frame: 3-months and 1-year ]
Quadriceps muscle strength (volitional and non-volitional) [ Time Frame: 3-months and 1-year ]
Cost-effectiveness (Index derived from EQ-5D) [ Time Frame: 3-months and 1-year ]

Estimated Enrollment:	60
Study Start Date:	January 2006
Estimated Study Completion Date:	January 2009

Arms	Assigned Interventions
Usual Care: No Intervention Usual Care (UC): usual follow up care post acute COPD exacerbation
EPR: Experimental Early pulmonary rehabilitation (EPR): pulmonary rehabilitation commenced within 1-week of hospital discharge from an acute COPD exacerbation	Other: Early pulmonary rehabilitation (EPR) Multidisciplinary exercise programme in the format of standard pulmonary rehabilitation. Consists of 2 supervised exercise and educations sessions per week for up to 16 sessions within 3-months. Participants are encouraged to keep an exercise diary at perform at least one exercise session at home unsupervised.

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Eligibility

Ages Eligible for Study:	40 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

All patients admitted to King's College Hospital with a clinical diagnosis of acute exacerbation of COPD. Patients with radiological and microbiological evidence of pneumonia with co−existing COPD will also be included.

Exclusion Criteria:

Significant co−morbidity that could limit exercise training & testing: Patients unable to walk due to a comorbid neuromuscular or rheumatological condition; patients with severe sensory and cognitive impairment; patients with unstable angina or aortic valve disease in which exercise could be dangerous.
Attendance at a pulmonary rehabilitation programme in the preceding year.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00557115

Contacts

Contact: John Moxham, MD FRCP	02032999000 ext 3185	julie.fuller@kch.nhs.uk
Contact: Mike I Polkey, PhD FRCP	0207 351 8029	m.polkey@rbht.nhs.uk

Locations

United Kingdom
King's College Hospital	Recruiting
London, United Kingdom, SE5 9RJ
Sub-Investigator: John M Seymour, MA MRCP
St Thomas' Hospital	Recruiting
London, United Kingdom, SE1 7EH
Contact: Nick Hart, PhD MRCP 02071889123 nicholas.hart@gstt.nhs.uk
United Kingdom, Essex
Basildon University Hospital	Recruiting
Basildon, Essex, United Kingdom
Contact: Bernard Yung, MD MRCP 01268 598688 Dr.Yung@btuh.nhs.uk

Sponsors and Collaborators

King's College Hospital NHS Trust

British Lung Foundation

Investigators

Principal Investigator:

John Moxham, MD FRCP

King's College London

More Information

Study ID Numbers:	05/Q0703/093, BLF PO4/8
Study First Received:	November 9, 2007
Last Updated:	November 9, 2007
ClinicalTrials.gov Identifier:	NCT00557115
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by King's College Hospital NHS Trust:

Quality of life
Quadriceps
Muscle
Exacerbation

Study placed in the following topic categories:

Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases
Quality of Life
Pulmonary Disease, Chronic Obstructive

ClinicalTrials.gov processed this record on January 15, 2009