Plain English Summary
Not provided at time of registration
Trial website
Contact information
Type
Scientific
Primary contact
Dr Milo Puhan
ORCID ID
Contact details
Horten Centre
University Hospital of Zurich
Postfach Nord
Zurich
8091
Switzerland
+41 (0)44 255 8709
milo.puhan@usz.ch
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
SOPRE
Study hypothesis
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
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.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Primary outcome measures
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 trial start date
11/09/2006
Overall trial end date
31/12/2009
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
280
Participant 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)
Recruitment start date
11/09/2006
Recruitment end date
31/12/2009
Locations
Countries of recruitment
Switzerland
Trial participating centre
Horten Centre
Zurich
8091
Switzerland
Sponsor information
Organisation
University Hospital of Zurich (Switzerland)
Sponsor details
c/o Prof. E. Russi
Division of Pulmonary Medicine
Raemistrasse 100
Zurich
8091
Switzerland
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Charity
Funder name
Swiss Lung league (Switzerland)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Lung leagues of Swiss cantons (Switzerland)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Klinik Barmelweid (Switzerland)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Quadrimed (Switzerland)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Zurcher Hoehenklinik Wald (Zurich Elevator Hospitals Forest) (Switzerland)
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
2009 recruitment results in http://www.ncbi.nlm.nih.gov/pubmed/19254374
Publication citations
-
Recruitment results
Spaar A, Frey M, Turk A, Karrer W, Puhan MA, Recruitment barriers in a randomized controlled trial from the physicians' perspective: a postal survey., BMC Med Res Methodol, 2009, 9, 14, doi: 10.1186/1471-2288-9-14.