Early Pulmonary Rehabilitation Following Acute COPD Exacerbation
The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2007 by King's College Hospital NHS Trust.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
King's College Hospital NHS Trust
Collaborator:
British Lung Foundation
Information provided by:
King's College Hospital NHS Trust
ClinicalTrials.gov Identifier:
NCT00557115
First received: November 9, 2007
Last updated: NA
Last verified: November 2007
History: No changes posted
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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 Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: 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:
MedlinePlus related topics:
COPD (Chronic Obstructive Pulmonary Disease)
Exercise and Physical Fitness
Rehabilitation
U.S. FDA Resources
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| 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 | |
| Basildon University Hospital | Recruiting |
| Basildon, Essex, United Kingdom | |
| Contact: Bernard Yung, MD MRCP 01268 598688 Dr.Yung@btuh.nhs.uk | |
| 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 | |
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
No publications provided by King's College Hospital NHS Trust
Additional 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 |
| Study First Received: | November 9, 2007 |
| Last Updated: | November 9, 2007 |
| 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 |
Additional relevant MeSH terms:
|
Pulmonary Disease, Chronic Obstructive Lung Diseases, Obstructive Lung Diseases Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 16, 2013