Condition category
Circulatory System
Date applied
10/07/2006
Date assigned
31/08/2006
Last edited
31/08/2006
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.refonet.de

Contact information

Type

Scientific

Primary contact

Dr Wolfgang Mayer-Berger

ORCID ID

Contact details

Roderbirken 1
Leichlingen
42799
Germany
+49 (0) 217 582 4010
wolfgang.mayer-berger@klinik-roderbirken.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

03002

Study information

Scientific title

Acronym

OpErgo

Study hypothesis

In accordance with the two training methods there are different training recommendations.

Ethics approval

Ethics Commitee of the Ärztekammer Nordrhein approved on the 31st August 2005 (reference number: 2005255).

Study design

Randomised, prospective, controlled trial.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/11/2005

Overall trial end date

31/10/2006

Reason abandoned

Eligibility

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 type

Patient

Age group

Not Specified

Gender

Both

Target number of participants

340

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

Locations

Countries of recruitment

Germany

Trial participating centre

Roderbirken 1
Leichlingen
42799
Germany

Sponsor information

Organisation

Refonet (Germany)

Sponsor details

Burgweg 3
Bad Neuenahr-Ahrweiler
53445
Germany
+49 (0) 264 190 620
service@refonet.de

Sponsor type

Not defined

Website

http://www.refonet.de

Funders

Funder type

Industry

Funder name

Refonet

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

Publication citations

Additional files

Editorial Notes