Clinical trial NCT04111744: Preoperative Excercise Training for Patients Undergoing Coronary Artery Bypass Graft Surgery
Official title: Preoperative Excercise Training for Patients Undergoing Coronary Artery Bypass Graft Surgery- A Prospective Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Physical Activity
Coronary Artery Bypass Graft Surgery
Keywords: Coronary Artery Bypass Graft Surgery
Physical Activity
Coronary Artery Disease
Physical Training
Lead sponsor: Kerckhoff Klinik
Sponsor class: OTHER
First posted: 2019-10-01
Enrollment: 203
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients enrolled to the study were randomised in a Treatment and a control Group
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Cardiopulmonary fitness
timeFrame: Baseline, prior surgery on hospital admission day, hospital discharge day ( postoperative day 7-14) , after 3 weeks of cardiac rehabilitation
measure: Endothelial function
timeFrame: Baseline, prior surgery on hospital admission day, hospital discharge day (postoperative day 7-14), after 3 weeks of cardiac rehabilitation
Secondary outcomes:
measure: Length of hospital stay (LoS)
timeFrame: Within the acute care period
measure: Length of ventilation
timeFrame: Within the acute care period
measure: Functional capacity
timeFrame: Baseline, prior surgery on hospital admission day, hospital discharge day(postoperative day 7-14), , after 3 weeks of cardiac rehabilitation
measure: Arterial stiffness
timeFrame: Baseline, prior surgery on hospital admission day, hospital discharge day(postoperative day 7-14), , after 3 weeks of cardiac rehabilitation
measure: Quality of life Questionnaire 1
timeFrame: Baseline, prior surgery on hospital admission day, hospital discharge day(postoperative day 7-14), , after 3 weeks of cardiac rehabilitation
measure: Quality of life Questionnaire 2
timeFrame: Baseline, prior surgery on hospital admission day, hospital discharge day(postoperative day 7-14), , after 3 weeks of cardiac rehabilitation
measure: Quality of life Questionnaire 3
timeFrame: Baseline, prior surgery on hospital admission day, hospital discharge day(postoperative day 7-14), , after 3 weeks of cardiac rehabilitation
measure: Ischemic blood marker 1
timeFrame: Baseline, prior surgery on hospital admission day, hospital discharge day(postoperative day 7-14), , after 3 weeks of cardiac rehabilitation
measure: Ischemic blood marker 2
timeFrame: Baseline, prior surgery on hospital admission day, hospital discharge day(postoperative day 7-14), , after 3 weeks of cardiac rehabilitation
measure: Ischemic blood marker 3
timeFrame: Baseline, prior surgery on hospital admission day, hospital discharge day(postoperative day 7-14), , after 3 weeks of cardiac rehabilitation
measure: Ischemic blood marker 4
timeFrame: Baseline, prior surgery on hospital admission day, hospital discharge day(postoperative day 7-14), , after 3 weeks of cardiac rehabilitation
measure: Ischemic blood marker 5
timeFrame: Baseline, prior surgery on hospital admission day, hospital discharge day(postoperative day 7-14), , after 3 weeks of cardiac rehabilitation
measure: Ischemic blood marker 6
timeFrame: Baseline, prior surgery on hospital admission day, hospital discharge day(postoperative day 7-14), , after 3 weeks of cardiac rehabilitation
measure: Ischemic blood marker 7
timeFrame: Baseline, prior surgery on hospital admission day, hospital discharge day(postoperative day 7-14), , after 3 weeks of cardiac rehabilitation
measure: Inflammatory blood marker 1
timeFrame: Baseline, prior surgery on hospital admission day, hospital discharge day(postoperative day 7-14), , after 3 weeks of cardiac rehabilitation
measure: Inflammatory blood marker 2
timeFrame: Baseline, prior surgery on hospital admission day, hospital discharge day(postoperative day 7-14), , after 3 weeks of cardiac rehabilitation
measure: Inflammatory blood marker 3
timeFrame: Baseline, prior surgery on hospital admission day, hospital discharge day(postoperative day 7-14), , after 3 weeks of cardiac rehabilitation
measure: Number of patients with a Clinical Event
timeFrame: Baseline, prior surgery on hospital admission day, hospital discharge day(postoperative day 7-14), , after 3 weeks of cardiac rehabilitation
measure: Number of patients with a Pulmonary clinical event
timeFrame: Baseline, prior surgery on hospital admission day, hospital discharge day(postoperative day 7-14), , after 3 weeks of cardiac rehabilitation
measure: Number of patients with a Cardiovascular event
timeFrame: after 30 days and 12 months
measure: Number of patients with a Cerebrovascular event
timeFrame: after 30 days and 12 months
Other outcomes:
Locations:
city: Bad Nauheim
country: Germany
facility: Kerckhoff Klinik
Study officials:
affiliation: Kerckhoff Clinic
name: Claudia Walther, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kerckhoff Clinik
name: Heike Baumgarten, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Steinmetz C, Bjarnason-Wehrens B, Baumgarten H, Walther T, Mengden T, Walther C. Prehabilitation in patients awaiting elective coronary artery bypass graft surgery - effects on functional capacity and quality of life: a randomized controlled trial. Clin Rehabil. 2020 Oct;34(10):1256-1267. doi: 10.1177/0269215520933950. Epub 2020 Jun 16.