Condition category
Respiratory
Date applied
25/04/2003
Date assigned
25/04/2003
Last edited
04/05/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.dh.gov.uk/en/index.htm

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

  1. 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.

Additional files

Editorial Notes