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Early Pulmonary Rehabilitation Following Acute COPD Exacerbation

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2007 by King's College Hospital NHS Trust.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00557115
First Posted: November 12, 2007
Last Update Posted: November 12, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
British Lung Foundation
Information provided by:
King's College Hospital NHS Trust
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Early Pulmonary Rehabilitation (PR) Following Hospitalisation For Acute Exacerbations of Chronic Obstructive Pulmonary Disease (COPD)

Resource links provided by NLM:


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
No Intervention: Usual Care
Usual Care (UC): usual follow up care post acute COPD exacerbation
Experimental: EPR
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.

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Basildon University Hospital Recruiting
Basildon, Essex, United Kingdom
Contact: Bernard Yung, MD MRCP    01268 598688    Dr.Yung@btuh.nhs.uk   
St Thomas' Hospital Recruiting
London, United Kingdom, SE1 7EH
Contact: Nick Hart, PhD MRCP    02071889123    nicholas.hart@gstt.nhs.uk   
King's College Hospital Recruiting
London, United Kingdom, SE5 9RJ
Sub-Investigator: John M Seymour, MA MRCP         
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00557115     History of Changes
Other Study ID Numbers: 05/Q0703/093
BLF PO4/8
First Submitted: November 9, 2007
First Posted: November 12, 2007
Last Update Posted: November 12, 2007
Last Verified: November 2007

Keywords provided by King's College Hospital NHS Trust:
Quality of life
Quadriceps
Muscle
Exacerbation

Additional relevant MeSH terms:
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases