Optimization of bicycle Ergometer training

ISRCTN	ISRCTN44341748
DOI	https://doi.org/10.1186/ISRCTN44341748
Secondary identifying numbers	03002

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English Summary

Not provided at time of registration

Dr Wolfgang Mayer-Berger
Scientific

Roderbirken 1
Leichlingen
42799
Germany

Phone	+49 (0) 217 582 4010
Email	wolfgang.mayer-berger@klinik-roderbirken.de

Study design	Randomised, prospective, controlled trial.
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title
Study acronym	OpErgo
Study hypothesis	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).
Condition	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	In accordance with the two training methods there are different training recommendations.
Secondary outcome measures	Training efficiency is enhanced by the intensity regulation based on metabolic parameters.
Overall study start date	01/11/2005
Overall study end date	31/10/2006

Participant type(s)	Patient
Age group	Not Specified
Sex	Both
Target number of participants	340
Participant 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
Participant 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
Recruitment start date	01/11/2005
Recruitment end date	31/10/2006

Roderbirken 1

Leichlingen
42799
Germany

Refonet (Germany)
Not defined

Burgweg 3
Bad Neuenahr-Ahrweiler
53445
Germany

Industry

Refonet

No information available

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