Optimization of bicycle Ergometer training
| ISRCTN | ISRCTN44341748 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN44341748 |
| Protocol serial number | 03002 |
| Sponsor | Refonet (Germany) |
| Funder | Refonet |
- Submission date
- 10/07/2006
- Registration date
- 31/08/2006
- Last edited
- 31/08/2006
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
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
Dr Wolfgang Mayer-Berger
Scientific
Scientific
Roderbirken 1
Leichlingen
42799
Germany
| Phone | +49 (0) 217 582 4010 |
|---|---|
| wolfgang.mayer-berger@klinik-roderbirken.de |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised, prospective, controlled trial. |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | OpErgo |
| Study objectives | In accordance with the two training methods there are different training recommendations. |
| Ethics approval(s) | Ethics Commitee of the Ärztekammer Nordrhein approved on the 31st August 2005 (reference number: 2005255). |
| Health condition(s) or problem(s) studied | Coronary heart disease |
| Intervention | Group one exercises with an intensity of 60% of the symptom-limited performance regulated by heart rate. Group two exercises metabolically regulated with an intenstity analogous to 60% of the intensity connected with 3 mmol/l lactate in capillary blood. |
| Intervention type | Other |
| Primary outcome measure(s) |
In accordance with the two training methods there are different training recommendations. |
| Key secondary outcome measure(s) |
Training efficiency is enhanced by the intensity regulation based on metabolic parameters. |
| Completion date | 31/10/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | All |
| Target sample size at registration | 340 |
| Key inclusion criteria | 1. Angiographic proved coronary disease 2. Echocardiogram (ECG) proved normal or slightly limited systolic cardiac function 3. Angina pectoris or acute coronary syndrome more than or equal to ten days before joining the research project 4. Sinus rhythm |
| Key exclusion criteria | 1. Acute coronary syndrome less than ten days before joining the research project 2. Moderate to severe limited sysolic cardiac function 3. Aorto-coronary bypass operation more than or equal to three months before joining the research project 4. Atrial fibrillations or therapy relevant ventricular arrythmia 5. Clinically limiting peripheral arterial disease 6. Present hypertrophic obstructive cardiac myopathy 7. Non-regulatable arterial hypertonia 8. Haemodynamically relevant cardiac valvular defect 9. Pericarditis, myocarditis and lung embolic more than or equal to six months before joining the research project 10. Limiting orthopaedic secondary disorders 11. Consuming and intercurrent diseases 12. Renal insufficiency (Creatinine > 2.0 mg/dl) 13. Anaemia (haemoglobin [Hb] < 12g/dl) 14. Severe chronic obstructive pulmonary disease (Forced Expiratory Volume in one second [FEV1] < 35%) 15. Respiratory global insufficiency 16. Implantable Cardioverter Defibrillator (ICD) implantation |
| Date of first enrolment | 01/11/2005 |
| Date of final enrolment | 31/10/2006 |
Locations
Countries of recruitment
- Germany
Study participating centre
Roderbirken 1
Leichlingen
42799
Germany
42799
Germany
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
