CardioPulmonary Exercise Testing in patients with Chronic Obstructive Pulmonary Disease
| ISRCTN | ISRCTN22314061 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN22314061 |
| Secondary identifying numbers | 001/2008 |
- Submission date
- 29/04/2008
- Registration date
- 15/05/2008
- Last edited
- 23/06/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Ralf Ewert
Scientific
Scientific
Ernst Moritz Arndt University Greifswald
Department of Internal Medicine
Pulmonary Medicine and Infectious Diseases
Friedrich Loeffler Strasse 23a
Greifswald
17489
Germany
| ewert@uni-greifswald.de |
Study information
| Study design | Observational study of consecutive patients |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Screening |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | |
| Study acronym | CPET in COPD |
| Study objectives | 1. Gas exchange data assessed by cardiopulmonary exercise testing (CPET) will provide profound prognostic and clinically relevant data to sub-classify patients with severe chronic obstructive pulmonary disease (COPD) 2. Different predefined standardised exercise protocols wont show relevant differences concerning CPET results in the assessment of COPD patients Please note that as of 23/06/2008 the funder and sponsor of this trial was changed to Ambulantes pneumologisches Zentrum GbR (Germany). Previous sponsor details can be found under the interventions section. |
| Ethics approval(s) | Ethics approval received from the Ethics Committee of the Ernst Moritz Arndt University of Greifswald on the 31st July 2007 (ref: BB48/07). |
| Health condition(s) or problem(s) studied | Chronic obstructive pulmonary disease (COPD) |
| Intervention | Patients suffering from COPD (according to the GOLD criteria classified as stage III and IV) will undergo CPET according to a standardised exercise protocol. In addition to the previous obtained spirometric and bodyplethysmographic data, a number of CPET data will be investigated. Based on this CPET data the aim of the study is to sub-classify patients into clinical and prognostic groups. The data of gas exchange during exercise might provide further insights in the exercise limiting disease related factors. The impact of the data might result in a new sub-classification of patients with severe COPD. Previous sponsor prior to 23/06/2008: Astra Zeneca GmbH (Germany) Tindsdaler Weg 183 Wedel, D-22880 Germany |
| Intervention type | Other |
| Primary outcome measure | 1. Exercise variables 2. Lung function data Primary and secondary outcomes will be assessed at the end of the study. |
| Secondary outcome measures | GOLD stage, assessed at the end of the study. |
| Overall study start date | 01/05/2008 |
| Completion date | 30/04/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 100 |
| Key inclusion criteria | 1. Diagnosis of COPD (according to American Thoracic Society [ATS] case definition) meeting all necessary criteria to be classified as Global Initiative for chronic Obstructive Lung Disease (GOLD) III and IV 2. Informed consent for study-related procedure 3. Stable medications for the last two weeks 4. Ability to safely perform the CPET without contraindications 5. Aged 18 - 80 years, both genders |
| Key exclusion criteria | 1. Existing contraindication for exercise test 2. Patients with clinically relevant congestive heart failure or other diseases which may influence the results of the study (e.g. handicaps) 3. Exacerbation of COPD within the last two weeks before CPET 4. Conditions associated with poor compliance 5. Patients who have participated in a clinical study within the last four weeks |
| Date of first enrolment | 01/05/2008 |
| Date of final enrolment | 30/04/2009 |
Locations
Countries of recruitment
- Germany
Study participating centre
Ernst Moritz Arndt University Greifswald
Greifswald
17489
Germany
17489
Germany
Sponsor information
Ambulantes pneumologisches Zentrum GbR (Germany)
Industry
Industry
c/o Dr Peter-Uwe Haase
Kleine Marktstrasse 3
Halle
D-06108
Germany
Funders
Funder type
Industry
Current funder as of 23/06/2008:
No information available
Ambulantes pneumologisches Zentrum GbR (Germany)
No information available
Previous funder:
No information available
Astra Zeneca GmbH (Germany)
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 |
