Preoperative Excercise Training for Patients Undergoing Coronary Artery Bypass Graft Surgery

Study Overview
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Brief Summary
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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
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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.

Official Title
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Preoperative Excercise Training for Patients Undergoing Coronary Artery Bypass Graft Surgery- A Prospective Randomized Trial

Conditions
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Coronary Artery Disease, Physical Activity, Coronary Artery Bypass Graft Surgery

Intervention / Treatment
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* Other: Preoperative Exercise Training
* Other: Optimal medical therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients enrolled to the study were randomised in a Treatment and a control Group
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Training Group<br>Preoperative Exercise Training Optimal medical therapy, | Other: Preoperative Exercise Training<br>* Patients undergoing CABG and randomized to the Training Group complete six sessions of aerobic endurance training prior CABG surgery<br>Other: Optimal medical therapy<br>* Standard medication for stable CAD<br>|
| Other: Control Group<br>Optimal medical therapy, inactive control group | Other: Optimal medical therapy<br>* Standard medication for stable CAD<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiopulmonary fitness | Change of maximal Oxygen consumption | 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) | Baseline, prior surgery on hospital admission day, hospital discharge day (postoperative day 7-14), after 3 weeks of cardiac rehabilitation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of hospital stay (LoS) | Duration of hospital stay in days | Within the acute care period | 
| Length of ventilation | Duration of Ventilation in minutes | Within the acute care period | 
| Functional capacity | Change of 6-minute walk test | 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 | 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 | Baseline, prior surgery on hospital admission day, hospital discharge day(postoperative day 7-14), , after 3 weeks of cardiac rehabilitation | 
| 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. | 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 | 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) | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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) | 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 | 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 | after 30 days and 12 months | 
| Number of patients with a Cerebrovascular event | TIA, stroke | after 30 days and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary Artery Bypass Graft Surgery, Physical Activity, Coronary Artery Disease, Physical Training