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
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
203
Patients undergoing CABG and randomized to the Training Group complete six sessions of aerobic endurance training prior CABG surgery
Standard medication for stable CAD
Kerckhoff Klinik
Bad Nauheim, Germany
Cardiopulmonary fitness
Change of maximal Oxygen consumption
Time frame: Baseline, prior surgery on hospital admission day, hospital discharge day ( postoperative day 7-14) , after 3 weeks of cardiac rehabilitation
Endothelial function
Change of Reactive hyperemic index (RHI)
Time frame: Baseline, prior surgery on hospital admission day, hospital discharge day (postoperative day 7-14), after 3 weeks of cardiac rehabilitation
Length of hospital stay (LoS)
Duration of hospital stay in days
Time frame: Within the acute care period
Length of ventilation
Duration of Ventilation in minutes
Time frame: Within the acute care period
Functional capacity
Change of 6-minute walk test
Time frame: Baseline, prior surgery on hospital admission day, hospital discharge day(postoperative day 7-14), , after 3 weeks of cardiac rehabilitation
Arterial stiffness
Changes in arterial pulse wave analysis
Time frame: Baseline, prior surgery on hospital admission day, hospital discharge day(postoperative day 7-14), , after 3 weeks of cardiac rehabilitation
Quality of life Questionnaire 1
Changes in MacNew (Heart Disease Health-related Quality of Life-) Questionnaire questionaire
Time frame: Baseline, prior surgery on hospital admission day, hospital discharge day(postoperative day 7-14), , after 3 weeks of cardiac rehabilitation
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Quality of life Questionnaire 2
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.
Time frame: Baseline, prior surgery on hospital admission day, hospital discharge day(postoperative day 7-14), , after 3 weeks of cardiac rehabilitation
Quality of life Questionnaire 3
Changes in Mobility and Self-supply (MOSES) questionnaire
Time frame: Baseline, prior surgery on hospital admission day, hospital discharge day(postoperative day 7-14), , after 3 weeks of cardiac rehabilitation
Ischemic blood marker 1
High Sensitive Troponin (hs-Trop)
Time frame: Baseline, prior surgery on hospital admission day, hospital discharge day(postoperative day 7-14), , after 3 weeks of cardiac rehabilitation
Ischemic blood marker 2
Creatine kinase (CK) U/L
Time frame: Baseline, prior surgery on hospital admission day, hospital discharge day(postoperative day 7-14), , after 3 weeks of cardiac rehabilitation
Ischemic blood marker 3
Creatine Kinase-MB (CK-MB) U/L
Time frame: Baseline, prior surgery on hospital admission day, hospital discharge day(postoperative day 7-14), , after 3 weeks of cardiac rehabilitation
Ischemic blood marker 4
Lactate dehydrogenase (LDH) U/L
Time frame: Baseline, prior surgery on hospital admission day, hospital discharge day(postoperative day 7-14), , after 3 weeks of cardiac rehabilitation
Ischemic blood marker 5
glutamic oxaloacetic transaminase (GOT) U/L
Time frame: Baseline, prior surgery on hospital admission day, hospital discharge day(postoperative day 7-14), , after 3 weeks of cardiac rehabilitation
Ischemic blood marker 6
glutamate pyruvate transaminase (GPT) U/L
Time frame: Baseline, prior surgery on hospital admission day, hospital discharge day(postoperative day 7-14), , after 3 weeks of cardiac rehabilitation
Ischemic blood marker 7
copeptin U/L
Time frame: Baseline, prior surgery on hospital admission day, hospital discharge day(postoperative day 7-14), , after 3 weeks of cardiac rehabilitation
Inflammatory blood marker 1
C-reactive protein (CRP) U/L
Time frame: Baseline, prior surgery on hospital admission day, hospital discharge day(postoperative day 7-14), , after 3 weeks of cardiac rehabilitation
Inflammatory blood marker 2
Leucozytes 10³/µL
Time frame: Baseline, prior surgery on hospital admission day, hospital discharge day(postoperative day 7-14), , after 3 weeks of cardiac rehabilitation
Inflammatory blood marker 3
Interleukine-6 (IL-6) pg/mL
Time frame: Baseline, prior surgery on hospital admission day, hospital discharge day(postoperative day 7-14), , after 3 weeks of cardiac rehabilitation
Number of patients with a Clinical Event
Atrial fibrillation documented by electrocardiogram (ECG)
Time frame: Baseline, prior surgery on hospital admission day, hospital discharge day(postoperative day 7-14), , after 3 weeks of cardiac rehabilitation
Number of patients with a Pulmonary clinical event
Pleural effusion, pulmonary infection or other pulmonary disorder with Need for treatment
Time frame: Baseline, prior surgery on hospital admission day, hospital discharge day(postoperative day 7-14), , after 3 weeks of cardiac rehabilitation
Number of patients with a Cardiovascular event
Revascularization, re-CABG, rehospitalization due to unstable angina, myocardial infarction
Time frame: after 30 days and 12 months
Number of patients with a Cerebrovascular event
TIA, stroke
Time frame: after 30 days and 12 months