Skip to main content
OpenTrials
Completed

NCT Number: NCT04111744

Preoperative Excercise Training for Patients Undergoing Coronary Artery Bypass Graft Surgery

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Behavior Cardiovascular Diseases Coronary Artery Bypass Graft Surgery Coronary Disease Heart Diseases Motor Activity Myocardial Ischemia Physical Activity Vascular Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kerckhoff Klinik

Bad Nauheim, 61231, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Preoperative Exercise Training

Other

Patients undergoing CABG and randomized to the Training Group complete six sessions of aerobic endurance training prior CABG surgery

Optimal medical therapy

Other

Standard medication for stable CAD

Primary outcomes

  1. Cardiopulmonary fitness

    Time frame: Baseline, prior surgery on hospital admission day, hospital discharge day ( postoperative day 7-14) , after 3 weeks of cardiac rehabilitation

    Change of maximal Oxygen consumption

  2. Endothelial function

    Time frame: Baseline, prior surgery on hospital admission day, hospital discharge day (postoperative day 7-14), after 3 weeks of cardiac rehabilitation

    Change of Reactive hyperemic index (RHI)

Secondary outcomes

  1. Length of hospital stay (LoS)

    Time frame: Within the acute care period

    Duration of hospital stay in days

  2. Length of ventilation

    Time frame: Within the acute care period

    Duration of Ventilation in minutes

  3. Functional capacity

    Time frame: Baseline, prior surgery on hospital admission day, hospital discharge day(postoperative day 7-14), , after 3 weeks of cardiac rehabilitation

    Change of 6-minute walk test

  4. Arterial stiffness

    Time frame: Baseline, prior surgery on hospital admission day, hospital discharge day(postoperative day 7-14), , after 3 weeks of cardiac rehabilitation

    Changes in arterial pulse wave analysis

  5. Quality of life Questionnaire 1

    Time frame: Baseline, prior surgery on hospital admission day, hospital discharge day(postoperative day 7-14), , after 3 weeks of cardiac rehabilitation

    Changes in MacNew (Heart Disease Health-related Quality of Life-) Questionnaire questionaire

  6. Quality of life Questionnaire 2

    Time frame: Baseline, prior surgery on hospital admission day, hospital discharge day(postoperative day 7-14), , after 3 weeks of cardiac rehabilitation

    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.

  7. Quality of life Questionnaire 3

    Time frame: Baseline, prior surgery on hospital admission day, hospital discharge day(postoperative day 7-14), , after 3 weeks of cardiac rehabilitation

    Changes in Mobility and Self-supply (MOSES) questionnaire

  8. Ischemic blood marker 1

    Time frame: Baseline, prior surgery on hospital admission day, hospital discharge day(postoperative day 7-14), , after 3 weeks of cardiac rehabilitation

    High Sensitive Troponin (hs-Trop)

  9. Ischemic blood marker 2

    Time frame: Baseline, prior surgery on hospital admission day, hospital discharge day(postoperative day 7-14), , after 3 weeks of cardiac rehabilitation

    Creatine kinase (CK) U/L

  10. Ischemic blood marker 3

    Time frame: Baseline, prior surgery on hospital admission day, hospital discharge day(postoperative day 7-14), , after 3 weeks of cardiac rehabilitation

    Creatine Kinase-MB (CK-MB) U/L

  11. Ischemic blood marker 4

    Time frame: Baseline, prior surgery on hospital admission day, hospital discharge day(postoperative day 7-14), , after 3 weeks of cardiac rehabilitation

    Lactate dehydrogenase (LDH) U/L

  12. Ischemic blood marker 5

    Time frame: Baseline, prior surgery on hospital admission day, hospital discharge day(postoperative day 7-14), , after 3 weeks of cardiac rehabilitation

    glutamic oxaloacetic transaminase (GOT) U/L

  13. Ischemic blood marker 6

    Time frame: Baseline, prior surgery on hospital admission day, hospital discharge day(postoperative day 7-14), , after 3 weeks of cardiac rehabilitation

    glutamate pyruvate transaminase (GPT) U/L

  14. Ischemic blood marker 7

    Time frame: Baseline, prior surgery on hospital admission day, hospital discharge day(postoperative day 7-14), , after 3 weeks of cardiac rehabilitation

    copeptin U/L

  15. Inflammatory blood marker 1

    Time frame: Baseline, prior surgery on hospital admission day, hospital discharge day(postoperative day 7-14), , after 3 weeks of cardiac rehabilitation

    C-reactive protein (CRP) U/L

  16. Inflammatory blood marker 2

    Time frame: Baseline, prior surgery on hospital admission day, hospital discharge day(postoperative day 7-14), , after 3 weeks of cardiac rehabilitation

    Leucozytes 10³/µL

  17. Inflammatory blood marker 3

    Time frame: Baseline, prior surgery on hospital admission day, hospital discharge day(postoperative day 7-14), , after 3 weeks of cardiac rehabilitation

    Interleukine-6 (IL-6) pg/mL

  18. Number of patients with a Clinical Event

    Time frame: Baseline, prior surgery on hospital admission day, hospital discharge day(postoperative day 7-14), , after 3 weeks of cardiac rehabilitation

    Atrial fibrillation documented by electrocardiogram (ECG)

  19. Number of patients with a Pulmonary clinical event

    Time frame: Baseline, prior surgery on hospital admission day, hospital discharge day(postoperative day 7-14), , after 3 weeks of cardiac rehabilitation

    Pleural effusion, pulmonary infection or other pulmonary disorder with Need for treatment

  20. Number of patients with a Cardiovascular event

    Time frame: after 30 days and 12 months

    Revascularization, re-CABG, rehospitalization due to unstable angina, myocardial infarction

  21. Number of patients with a Cerebrovascular event

    Time frame: after 30 days and 12 months

    TIA, stroke

Sponsors and collaborators

Lead sponsor

Kerckhoff Klinik

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Oct 1, 2019
Registry last updated
Oct 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.