Coronary artery bypass grafting
Conditions
Interventions
Usual Care PathwayThe decision-making process for elective cardiac surgery at the MUMC+ is initiated by a joint review between a cardiologist and a cardiothoracic surgeon. During this consultation, th
for postoperative in-hospital complications and delayed functional recovery during hospitalization based on the EuroSCORE II. Following this definitive assessment, the patient is officially scheduled
All study participants will undergo elective cardiac surgery (CABG or AVR) within approximately five weeks or more following baseline assessment. The preoperative physical intervention will span a min
Sponsors
Maastricht Universitair Medisch Centrum +
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Participants must meet all of the following criteria to be eligible for inclusion:Age: =18 years.Surgical procedure: Scheduled to undergo elective CABG or AVR via median sternotomy; Allowed concomitant procedures: Isolated procedures or in combination with concomitant procedures (i.e., MAZE, Pulmonary Vein Isolation (PVI), clip Left Arterial Appendage (LAA)).High-risk classification: Participants are classified as high-risk for postoperative in-hospital complications or delayed functional recovery during hospitalization using a predefined two-stage screening process.Stage 1: Elevated surgical risk Patients are initially screened based on surgical risk, defined as a EuroSCORE II = 1.33.Stage 2: Multivariable confirmation Patients meeting Stage 1 criteria undergo further risk stratification using internally developed and validated multivariable prediction models. These models integrate surgical risk and modifiable physical risk factors, including:EuroSCORE II (ESII); cardiorespiratory fitness (FitMáx); frailty (Edmonton Frail Scale, EFS); body mass index (BMI). Following logistic regression model is applied:Prediction of delayed postoperative recovery of physical functioning: Phigh risk=<img src="data:image/png;base64,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
Exclusion criteria
Exclusion criteria: Participants will be excluded if they meet any of the following criteria:Procedure-related: Scheduled for combined CABG and AVR, or combined with MVP and/or TVP, or combined with aortic aneurysm repairMedical conditions, as described in the electronic medical record (EMR): Patients with a known Ascending Aorta Diameter (AAD) >45mm or any patient with an AAD > 40mm if they have an associated high-risk condition, including a known genetic connective tissue disorder or a history of aortic dissection. Recent acute coronary syndrome (< 3 weeks) Recent inflammatory myo-pericardial syndrome (<1 month after remission) as recommended in the ESC Guidelines for the management of myo- and pericarditisConduction disturbances and/or arrhythmias with pacemaker (PM) or Implantable Cardioverter Defibrillator (ICD) indication without a device implanted yet.Decompensated heart failure or cardiomyopathy contraindicating exercise.Atrial fibrillation or other tachyarrhythmias with resting heart rate >120 bpm.Exercise and functional limitations, as described in the EMR:Left main coronary artery stenosis >80%History of frequent exercise-induced syncope’s in Aortic valve Stenosis (AoS) and Aortic valve Insufficiency (AoI) patients Physical impairments that makes it impossible to complete the assessments and the prehabilitation program, as determined by an experienced physiotherapist.Cognitive impairment (e.g. dementia) that would impede understanding of study procedures, informed consent, or study questionnaires described by the medical specialist in the EMR.Incapacitated subjects as reported by the attending medical specialist in the medical record. (When any doubt arises, the patient will not be considered eligible).Exercise safety issues during the CPET at baseline measurement Serious-exercise induced ischemiaSerious exercise-induced (supra-)ventricular arrhythmias
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Study parameterDefinition / outcome measureTime point(s) measuredRecruitmentRecruitment rate (%)Number of included patients within the study periodWeek 0Ineligibility rate due to CPET safety criteria (%)Number of patients withdrawn due to safety criteria Week 0Characteristics of included participantsDemographics, type of disease, type of surgery, EuroSCORE II, BMI, Left Vetricular Ejection Fraction (LVEF), kidney function, New York Heart Association (NYHA) class, Short Form 36 (SF-36) and the EuroQol-5 Dimensions (EQ-5D), comorbidities, cardiac biochemical markers (troponine and Creatine kinase-MB (CK-MB)), EFS results, and FITmáx results.Week 0Adherence – supervised sessionsAttendance rate for physiotherapist-supervised groups sessions (%)Number of attended sessions / total number of planned sessions Week 0-4~6Adherence rate, Exercise Relative Dose Intensity ExRDI cardiorespiratory training (%)ExRDI cardiorespiratory training = completed exercise dose intensity / prescribed exercise dose intensity.Interval training (CABG)• Completed = S (completed work-interval duration [min] × completed work rate [WR]). • Prescribed = S (prescribed work-interval duration [min] × prescribed work rate [WR]).Continuous training (AVR) • Completed = total completed duration [min] × completed work rate [WR].• Prescribed = total prescribed duration [min] × prescribed work rate [WR]. ExRDI cardiorespiratory training is calculated for each participant individually, cumulative for all training sessions; and cumulative for all participants.Week 0-4~6Adherence rate, EXRDI peripheral strength training (%)ExRDI peripheral strength training = completed exercise dose intensity / prescribed exercise dose intensity. • Completed = completed weight [kg] × sets [N] × repetitions [N] per exercise.• Prescribed = prescribed weight [kg] × sets [N] × repetitions [N] per exercise.ExRDI peripheral strength training is calculated per participant p | — |
Secondary
| Measure | Time frame |
|---|---|
| ParameterDefinition / outcome measureTime point(s) measuredCardiorespiratory fitness-Ventilatory thresholds VT1 and VT2 determined by CPET. -WRpeak (W/kg) as determined by the Steep Ramp Test (SRT)--Estimated VO2max (ml/kg/min) determined by FitMáx.Baseline (Week 0) and evaluation (last week before surgery).Peripheral muscle strength-8-10-repetition maximum (8-10-RM, kg) determined indirectly via validated submaximal RM tests on leg press, chest press, leg extension, and vertical traction equipment.Baseline (Week 0) and evaluation (last week before surgery).Inspiratory muscle strength-Maximum Inspiratory Pressure (MIP) (cmH2O)Baseline (Week 0) and Weekly. Physical activity behaviour and home based exercise programDiary data collected continuously during the intervention by the PAM and diary.Diary: continuously during intervention. Postoperative in-hospital complicationsData extraction of usual care data for Nederlandse Hart Regristratie (NHR).After hospitalization/ discharge Postoperative recovery of functioningData extraction of usual care data modified Iowa Level of Assistance Scale (mILAS) daily assessments by a physiotherapist.After hospitalization/ dischargePostoperative quality of liveExtraction of usual care data: SF-36 and EQ-5DThree months postoperatively | — |
Countries
Netherlands
Contacts
Public ContactZ Hoofd
Maastricht Universitair Medisch Centrum +
Outcome results
None listed