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
Scientific
Dept of Respiratory Medicine
Royal Hallamshire Hospital
Glossop Road
Sheffield
S10 2JF
United Kingdom
| Phone | +44 0 114 271 2958 |
|---|---|
| rod.lawson@sth.nhs.uk |
Study information
| Study design | Randomised 2x2 factorial trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Scientific title | |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/11/2002 |
| Completion date | 31/07/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Both |
| Target number of participants | Added 04/05/10: 240 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/11/2002 |
| Date of final enrolment | 31/07/2007 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Dept of Respiratory Medicine
Sheffield
S10 2JF
United Kingdom
S10 2JF
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom
| Phone | +44 (0)1132 545 843 |
|---|---|
| Sheila.Greener@doh.gsi.gov.uk | |
| Website | http://www.dh.gov.uk/en/index.htm |
"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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not 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 |
