Swiss Study On Pulmonary Rehabilitation after Exacerbation
| ISRCTN | ISRCTN84612310 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN84612310 |
| Secondary identifying numbers | N/A |
- Submission date
- 06/09/2006
- Registration date
- 30/10/2006
- Last edited
- 18/03/2009
- 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 Milo Puhan
Scientific
Scientific
Horten Centre
University Hospital of Zurich
Postfach Nord
Zurich
8091
Switzerland
| Phone | +41 (0)44 255 8709 |
|---|---|
| milo.puhan@usz.ch |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study acronym | SOPRE |
| Study objectives | Early respiratory rehabilitation after acute exacerbation of Chronic Obstructive Pulmonary Disease (COPD) reduces exacerbations requiring medical treatment during an 18 months follow-up compared to respiratory rehabilitation in stable state after six months in patients with COPD Global initiative for chronic Obstructive Lung Disease (GOLD) stage II to IV and a history of repeated exacerbations. |
| Ethics approval(s) | Zurich REB (EK1286), St.Gallen REB (EKSG 06/071/1B), Schaffhausen REB (EK1286), ethics approval also received from the ethics committees of Lucerne, Bern and Thurgau. |
| Health condition(s) or problem(s) studied | Chronic obstructive pulmonary disease |
| Intervention | Respiratory rehabilitation with supervised physical exercise for 12 weeks and patient education program "Living well with COPD" (identical for both treatment arms). |
| Intervention type | Other |
| Primary outcome measure | Exacerbations requiring medical care (in- or outpatient). |
| Secondary outcome measures | 1. Health-related quality of life (Chronic Respiratory Questionnaire and Feeling Thermometer) 2. Dyspnea (Medical Research Council scale) 3. Mortality 4. Costs |
| Overall study start date | 11/09/2006 |
| Completion date | 31/12/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 280 |
| Key inclusion criteria | 1. Patients after in- or outpatient treatment of acute exacerbation of COPD defined as a sustained worsening over days to weeks of the patients symptoms from his or her usual stable state that is beyond normal day-to-day variations and the presence of at least two of the following symptoms: 1.1. Breathlessness 1.2. Cough 1.3. Increased sputum production, and 1.4. Change in sputum colour 2. At least two exacerbations in previous two years requiring in- or outpatient care 3. Within last three years, during stable phase, documented COPD with Gold stage II to IV 4. The patient is after in- or outpatient treatment in a medical condition that allows an immediate respiratory rehabilitation or recovery at home 5. More than 40 years of age |
| Key exclusion criteria | 1. Hospitalisation for other reasons than acute exacerbation of COPD 2. Long term non-invasive ventilation (all but continuous positive airway pressure [CPAP], which is allowed) 3. Other lung diseases: Doctor diagnosed asthma and/or more than 20% reversibility of airflow obstruction after beta-2-mimetika during stable phase of COPD 4. Patients who cannot be randomised to usual care for medical reasons: 4.1. Impaired level of consciousness 4.2. Acute confusion 4.3. Acute changes on the radiograph or electrocardiogram 4.4. Arterial pH less than 7.35, or 4.5. Concomitant medical conditions 5. Orthopaedic, rheumatologic, cardiovascular or neurological disorders that inhibit exercise training, gymnastic or guided walking tours 6. Inability to follow patient education due to language (no German, French or Italian as communication language) or mental disorders (e.g. substance abuse, psychosis, dementia) |
| Date of first enrolment | 11/09/2006 |
| Date of final enrolment | 31/12/2009 |
Locations
Countries of recruitment
- Switzerland
Study participating centre
Horten Centre
Zurich
8091
Switzerland
8091
Switzerland
Sponsor information
University Hospital of Zurich (Switzerland)
Hospital/treatment centre
Hospital/treatment centre
c/o Prof. E. Russi
Division of Pulmonary Medicine
Raemistrasse 100
Zurich
8091
Switzerland
| Website | http://www.unizh.ch/ |
|---|---|
"ROR" |
https://ror.org/01462r250 |
Funders
Funder type
Charity
Swiss Lung league (Switzerland)
No information available
Lung leagues of Swiss cantons (Switzerland)
No information available
Klinik Barmelweid (Switzerland)
No information available
Quadrimed (Switzerland)
No information available
Zurcher Hoehenklinik Wald (Zurich Elevator Hospitals Forest) (Switzerland)
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 | recruitment results | 02/03/2009 | Yes | No |
