Preoperative Excercise Training for Patients Undergoing Coronary Artery Bypass Graft Surgery
- Conditions
- Coronary Artery Bypass Graft SurgeryPhysical ActivityCoronary Artery Disease
- Interventions
- Other: Preoperative Exercise TrainingOther: Optimal medical therapy
- Registration Number
- NCT04111744
- Lead Sponsor
- Kerckhoff Klinik
- Brief Summary
Patients (pts) with stable coronary artery disease (CAD) requiring coronary artery bypass graft surgery (CABG) may be physically inactive during the waiting period to avoid further risks. Aim of this study is to investigate the feasibility and safety of a preoperative aerobic exercise training in these pts during the waiting period and to analyze its effects on pre-, peri and postoperative outcomes
- Detailed Description
Pts with stable coronary artery disease (CAD) and indication for elective CABG will be prospectively randomized into a preoperative training group (TG) or a non active control group (CG). Pts in TG have to perform six sessions of aerobic endurance training within two weeks prior to CABG. The following investigations will be performed at baseline, one day before surgery and at the beginning and at the end of cardiac rehabilitation: a maximal symptom limited ergospirometry, assessment of endothelial function (analysing the reactive hyperaemic index (RHI) via a finger-tonometry), assessment of quality of life (QoL) using the MacNew Heart Disease Questionnaire, laboratory testing of ischemic and inflammatory Parameters. Baseline, peri- and postoperative characteristics will be collected.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 203
- stable Angina
- indication for elective CABG surgery
- functional capacity > 50 watts
- willingness to participate in the study
- unstable Angina
- comorbidities precluding performance of aerobic exercise training (e.g. neurological disorders, orthopedic disorders etc)
- functional Status NYHA IV
- relevant ventricular arrhythmias
- hemodynamic significant heart valve disease
- myocarditis
- cardiomyopathies
- left main coronary artery disease > 50%
- peripheral obstructive disease (Fontaine > IIb)
- reduced life expectancy < 12 months
- CABG surgery during the last six months
- participation in another trial
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Training Group Preoperative Exercise Training Preoperative Exercise Training Optimal medical therapy, Training Group Optimal medical therapy Preoperative Exercise Training Optimal medical therapy, Control Group Optimal medical therapy Optimal medical therapy, inactive control group
- Primary Outcome Measures
Name Time Method Cardiopulmonary fitness Baseline, prior surgery on hospital admission day, hospital discharge day ( postoperative day 7-14) , after 3 weeks of cardiac rehabilitation Change of maximal Oxygen consumption
Endothelial function Baseline, prior surgery on hospital admission day, hospital discharge day (postoperative day 7-14), after 3 weeks of cardiac rehabilitation Change of Reactive hyperemic index (RHI)
- Secondary Outcome Measures
Name Time Method Length of hospital stay (LoS) Within the acute care period Duration of hospital stay in days
Ischemic blood marker 6 Baseline, prior surgery on hospital admission day, hospital discharge day(postoperative day 7-14), , after 3 weeks of cardiac rehabilitation glutamate pyruvate transaminase (GPT) U/L
Inflammatory blood marker 2 Baseline, prior surgery on hospital admission day, hospital discharge day(postoperative day 7-14), , after 3 weeks of cardiac rehabilitation Leucozytes 10³/µL
Length of ventilation Within the acute care period Duration of Ventilation in minutes
Ischemic blood marker 3 Baseline, prior surgery on hospital admission day, hospital discharge day(postoperative day 7-14), , after 3 weeks of cardiac rehabilitation Creatine Kinase-MB (CK-MB) U/L
Ischemic blood marker 7 Baseline, prior surgery on hospital admission day, hospital discharge day(postoperative day 7-14), , after 3 weeks of cardiac rehabilitation copeptin U/L
Number of patients with a Pulmonary clinical event Baseline, prior surgery on hospital admission day, hospital discharge day(postoperative day 7-14), , after 3 weeks of cardiac rehabilitation Pleural effusion, pulmonary infection or other pulmonary disorder with Need for treatment
Functional capacity Baseline, prior surgery on hospital admission day, hospital discharge day(postoperative day 7-14), , after 3 weeks of cardiac rehabilitation Change of 6-minute walk test
Quality of life Questionnaire 2 Baseline, prior surgery on hospital admission day, hospital discharge day(postoperative day 7-14), , after 3 weeks of cardiac rehabilitation Changes in Hospital Anxiety and Depression Scale (HADS) questionnaire: The HADS is a fourteen item scale that generates ordinal data.Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression.
Quality of life Questionnaire 3 Baseline, prior surgery on hospital admission day, hospital discharge day(postoperative day 7-14), , after 3 weeks of cardiac rehabilitation Changes in Mobility and Self-supply (MOSES) questionnaire
Ischemic blood marker 1 Baseline, prior surgery on hospital admission day, hospital discharge day(postoperative day 7-14), , after 3 weeks of cardiac rehabilitation High Sensitive Troponin (hs-Trop)
Ischemic blood marker 2 Baseline, prior surgery on hospital admission day, hospital discharge day(postoperative day 7-14), , after 3 weeks of cardiac rehabilitation Creatine kinase (CK) U/L
Ischemic blood marker 5 Baseline, prior surgery on hospital admission day, hospital discharge day(postoperative day 7-14), , after 3 weeks of cardiac rehabilitation glutamic oxaloacetic transaminase (GOT) U/L
Inflammatory blood marker 1 Baseline, prior surgery on hospital admission day, hospital discharge day(postoperative day 7-14), , after 3 weeks of cardiac rehabilitation C-reactive protein (CRP) U/L
Inflammatory blood marker 3 Baseline, prior surgery on hospital admission day, hospital discharge day(postoperative day 7-14), , after 3 weeks of cardiac rehabilitation Interleukine-6 (IL-6) pg/mL
Arterial stiffness Baseline, prior surgery on hospital admission day, hospital discharge day(postoperative day 7-14), , after 3 weeks of cardiac rehabilitation Changes in arterial pulse wave analysis
Quality of life Questionnaire 1 Baseline, prior surgery on hospital admission day, hospital discharge day(postoperative day 7-14), , after 3 weeks of cardiac rehabilitation Changes in MacNew (Heart Disease Health-related Quality of Life-) Questionnaire questionaire
Ischemic blood marker 4 Baseline, prior surgery on hospital admission day, hospital discharge day(postoperative day 7-14), , after 3 weeks of cardiac rehabilitation Lactate dehydrogenase (LDH) U/L
Number of patients with a Clinical Event Baseline, prior surgery on hospital admission day, hospital discharge day(postoperative day 7-14), , after 3 weeks of cardiac rehabilitation Atrial fibrillation documented by electrocardiogram (ECG)
Number of patients with a Cardiovascular event after 30 days and 12 months Revascularization, re-CABG, rehospitalization due to unstable angina, myocardial infarction
Number of patients with a Cerebrovascular event after 30 days and 12 months TIA, stroke
Trial Locations
- Locations (1)
Kerckhoff Klinik
🇩🇪Bad Nauheim, Germany