Contact information
Type
Scientific
Primary contact
Dr Roderick Allan Lawson
ORCID ID
Contact details
Dept of Respiratory Medicine
Royal Hallamshire Hospital
Glossop Road
Sheffield
S10 2JF
United Kingdom
+44 0 114 271 2958
rod.lawson@sth.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
HTA 01/15/10
Study information
Scientific title
Acronym
Study hypothesis
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.
Ethics approval
Not provided at time of registration
Study design
Randomised 2x2 factorial trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Condition
Chronic obstructive pulmonary disease
Intervention
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
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Added 04/05/10:
Shuttle walking test (ESWT), assessed post-rehabilitation and at 18 months
Secondary outcome measures
Added 04/05/10:
Health-related quality of life, assessed by Chronic Respiratory Questionnaire (CRQ), Short form-36 (SF-36) and EuroQol (EQ-5D)
Overall trial start date
01/11/2002
Overall trial end date
31/07/2007
Reason abandoned
Eligibility
Participant inclusion criteria
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
Participant type
Patient
Age group
Not Specified
Gender
Both
Target number of participants
Added 04/05/10: 240
Participant exclusion criteria
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
Recruitment start date
01/11/2002
Recruitment end date
31/07/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Dept of Respiratory Medicine
Sheffield
S10 2JF
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom
+44 (0)1132 545 843
Sheila.Greener@doh.gsi.gov.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NIHR Health Technology Assessment Programme - HTA (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20146902
Publication citations
-
Results
Waterhouse JC, Walters SJ, Oluboyede Y, Lawson RA, A randomised 2 x 2 trial of community versus hospital pulmonary rehabilitation, followed by telephone or conventional follow-up., Health Technol Assess, 2010, 14, 6, i-v, vii-xi, 1-140, doi: 10.3310/hta14060.