Coronary Artery Bypass Graft Surgery, Coronary Artery Disease, Physical Activity
Conditions
Keywords
Coronary Artery Bypass Graft Surgery, Physical Activity, Coronary Artery Disease, Physical Training
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.
Interventions
Patients undergoing CABG and randomized to the Training Group complete six sessions of aerobic endurance training prior CABG surgery
OTHEROptimal medical therapy
Standard medication for stable CAD
Sponsors
Kerckhoff Klinik
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Intervention model description
Patients enrolled to the study were randomised in a Treatment and a control Group
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* stable Angina * indication for elective CABG surgery * functional capacity \> 50 watts * willingness to participate in the study
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Length of ventilation | Within the acute care period | Duration of Ventilation in minutes |
| 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 |
| 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 |
| 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 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 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 |
| 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 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 |
| 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 |
| 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 2 | Baseline, prior surgery on hospital admission day, hospital discharge day(postoperative day 7-14), , after 3 weeks of cardiac rehabilitation | Leucozytes 10³/µL |
| 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 |
| 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 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 |
| 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 |
| 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 |
| Length of hospital stay (LoS) | Within the acute care period | Duration of hospital stay in days |
Countries
Germany
Outcome results
None listed