Condition category
Respiratory
Date applied
06/09/2006
Date assigned
30/10/2006
Last edited
18/03/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.research-projects.unizh.ch/p7675.htm

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 patient’s 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

http://www.unizh.ch/

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

  1. 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.

Additional files

Editorial Notes