Preoperative Excercise Training for Patients Undergoing Coronary Artery Bypass Graft Surgery

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04111744
• Other study ID #: PRECAB
• Status: Completed
• Phase: N/A
• Start date: January 1, 2015
• Est. completion date: December 31, 2018

Study information

• Verified date: September 2019
• Source: Kerckhoff Klinik
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 203
• Est. completion date: December 31, 2018
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Bypass Graft Surgery
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia
• Physical Activity

Intervention

Other:
• Preoperative Exercise Training
Patients undergoing CABG and randomized to the Training Group complete six sessions of aerobic endurance training prior CABG surgery
• Optimal medical therapy
Standard medication for stable CAD

Locations

Country	Name	City	State
Germany	Kerckhoff Klinik	Bad Nauheim

Sponsors (1)

Lead Sponsor	Collaborator
Kerckhoff Klinik

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Length of hospital stay (LoS)	Duration of hospital stay in days	Within the acute care period
Secondary	Length of ventilation	Duration of Ventilation in minutes	Within the acute care period
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Number of patients with a Cardiovascular event	Revascularization, re-CABG, rehospitalization due to unstable angina, myocardial infarction	after 30 days and 12 months
Secondary	Number of patients with a Cerebrovascular event	TIA, stroke	after 30 days and 12 months