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ISRCTN
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ISRCTN86821773
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ClinicalTrials.gov identifier
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Public title
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A randomised 2x2 trial of community versus hospital rehabilitation, followed by telephone or conventional follow up; impact on quality of life, exercise capacity and use of health care resources
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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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HTA 01/15/10
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Study hypothesis
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Pulmonary rehabilitation is a program of supervised exercises and education to improve the function and quality of life of patients with chronic obstructive pulmonary disease (COPD) (chronic lung disease, predominantly caused by smoking). To date, this treatment has usually been carried out in hospital, where research has already shown it to be effective. Programs typically last for 6 weeks, but improvements persist much longer. For maximum benefit patients must be assisted to change their lifestyles. It is possible that the importance attached to being treated in hospital is more likely to convince patients to change their lifestyles. Alternatively, those treated in a community setting may identify the treatment more with day to day life and hence be more likely to make ongoing changes. This study randomises patients to receive their rehabilitation program in either hospital or community setting to see if one is superior to the other. This will be evaluated over 18 months to see how the effect persists, with measures of purely physical function (exercise), quality of life and use of healthcare status being evaluated. In addition, half of the patients will receive telephone support to see if this can cost effectively enhance the persistence of treatment effect.
More details can be found at http://www.hta.ac.uk/1316
Please note that, as of 24 January 2008, the start and end date of this trial were updated from 1 July 2002 and 30 June 2006 to 1 November 2002 and 31 July 2007, respectively.
Please note that as of 04/05/10 this record was extensively updated. All updates can be found in the relevant field with the above update date.
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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 2x2 factorial 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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Added 04/05/10:
1. Diagnosis of COPD as defined by British Thoracic Society guidelines
2. Medical Research Council (MRC) grade 3 dyspnoea or worse despite optimal care
3. Clinically stable 4 weeks prior to commencing programme
4. Written informed consent
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Participants - exclusion criteria
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Added 04/05/10:
1. Lack of informed consent
2. Unwilling/lack of motivation to make lifestyle changes
3. Inability to hear and understand educational talks and exercise instructions (hearing aids and interpreters may be used if appropriate)
4. Prognosis under 2 years from any disease
5. Long term oxygen therapy or any requirement for oxygen therapy on exercise
6. Unstable or uncontrolled cardiac disease
7. Musculoskeletal problems precluding exercise training
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Anticipated start date
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01/11/2002
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Anticipated end date
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31/07/2007
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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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Added 04/05/10: 240
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Interventions
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Participants were randomised to one of four groups:
1. Hospital rehabilitation with no telephone follow-up
2. Hospital rehabilitation with telephone follow-up
3. Community rehabilitation with no telephone follow-up
4. Community rehabilitation with telephone follow-up
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Primary outcome measure(s)
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Added 04/05/10:
Shuttle walking test (ESWT), assessed post-rehabilitation and at 18 months
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Secondary outcome measure(s)
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Added 04/05/10:
Health-related quality of life, assessed by Chronic Respiratory Questionnaire (CRQ), Short form-36 (SF-36) and EuroQol (EQ-5D)
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Sources of funding
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NIHR Health Technology Assessment Programme - HTA (UK)
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Trial website
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Publications
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2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20146902
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Contact name
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Dr
Roderick Allan
Lawson
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Address
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Dept of Respiratory Medicine
Royal Hallamshire Hospital
Glossop Road
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City/town
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Sheffield
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Zip/Postcode
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S10 2JF
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Country
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United Kingdom
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Tel
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+44 0 114 271 2958
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Fax
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+44 0 114 271 1836
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Email
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rod.lawson@sth.nhs.uk
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Sponsor
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Department of Health (UK)
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Address
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Quarry House
Quarry Hill
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City/town
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Leeds
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Zip/Postcode
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LS2 7UE
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Country
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United Kingdom
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Tel
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+44 (0)1132 545 843
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Email
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Sheila.Greener@doh.gsi.gov.uk
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Sponsor website:
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http://www.dh.gov.uk/en/index.htm
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Date applied
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25/04/2003
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Last edited
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04/05/2010
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Date ISRCTN assigned
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25/04/2003
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