Preoperative Excercise Training for Patients Undergoing Coronary Artery Bypass Graft Surgery

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

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

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease; Physical Activity; Coronary Artery Bypass Graft Surgery
• Intervention / Treatment: Other: Preoperative Exercise Training; Other: Optimal medical therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 203
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Bad Nauheim, Germany, 61231
    • Kerckhoff Klinik

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Kerckhoff Klinik
• Investigators: Principal Investigator: Claudia Walther, MD, Kerckhoff Clinic; Principal Investigator: Heike Baumgarten, MD, Kerckhoff Clinik

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Actual): June 30, 2018
• Study Completion (Actual): December 31, 2018

Study Registration Dates

• First Submitted: March 21, 2018
• First Submitted That Met QC Criteria: September 30, 2019
• First Posted (Actual): October 1, 2019

Study Record Updates

• Last Update Posted (Actual): October 1, 2019
• Last Update Submitted That Met QC Criteria: September 30, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Physical Activity; Coronary Artery Disease; Coronary Artery Bypass Graft Surgery; Physical Training
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: PRECAB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No