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

ISRCTN ISRCTN86821773
DOI https://doi.org/10.1186/ISRCTN86821773
Secondary identifying numbers HTA 01/15/10
Submission date
25/04/2003
Registration date
25/04/2003
Last edited
04/05/2010
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Roderick Allan Lawson
Scientific

Dept of Respiratory Medicine
Royal Hallamshire Hospital
Glossop Road
Sheffield
S10 2JF
United Kingdom

Phone +44 0 114 271 2958
Email rod.lawson@sth.nhs.uk

Study information

Study designRandomised 2x2 factorial trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeTreatment
Scientific title
Study objectivesPulmonary 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedChronic obstructive pulmonary disease
InterventionParticipants 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 typeOther
Primary outcome measureAdded 04/05/10:
Shuttle walking test (ESWT), assessed post-rehabilitation and at 18 months
Secondary outcome measuresAdded 04/05/10:
Health-related quality of life, assessed by Chronic Respiratory Questionnaire (CRQ), Short form-36 (SF-36) and EuroQol (EQ-5D)
Overall study start date01/11/2002
Completion date31/07/2007

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexBoth
Target number of participantsAdded 04/05/10: 240
Key inclusion criteriaAdded 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
Key exclusion criteriaAdded 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
Date of first enrolment01/11/2002
Date of final enrolment31/07/2007

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Dept of Respiratory Medicine
Sheffield
S10 2JF
United Kingdom

Sponsor information

Department of Health (UK)
Government

Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom

Phone +44 (0)1132 545 843
Email Sheila.Greener@doh.gsi.gov.uk
Website http://www.dh.gov.uk/en/index.htm
ROR logo "ROR" https://ror.org/03sbpja79

Funders

Funder type

Government

NIHR Health Technology Assessment Programme - HTA (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/02/2010 Yes No