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Preoperative Excercise Training for Patients Undergoing Coronary Artery Bypass Graft Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04111744
Recruitment Status : Completed
First Posted : October 1, 2019
Last Update Posted : October 1, 2019
Sponsor:
Information provided by (Responsible Party):
Kerckhoff Klinik

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

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Physical Activity Coronary Artery Bypass Graft Surgery Other: Preoperative Exercise Training Other: Optimal medical therapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 203 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients enrolled to the study were randomised in a Treatment and a control Group
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Preoperative Excercise Training for Patients Undergoing Coronary Artery Bypass Graft Surgery- A Prospective Randomized Trial
Actual Study Start Date : January 1, 2015
Actual Primary Completion Date : June 30, 2018
Actual Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine


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

Control Group
Optimal medical therapy, inactive control group
Other: Optimal medical therapy
Standard medication for stable CAD




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04111744


Locations
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Germany
Kerckhoff Klinik
Bad Nauheim, Germany, 61231
Sponsors and Collaborators
Kerckhoff Klinik
Investigators
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Principal Investigator: Claudia Walther, MD Kerckhoff Clinic
Principal Investigator: Heike Baumgarten, MD Kerckhoff Clinik
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Kerckhoff Klinik
ClinicalTrials.gov Identifier: NCT04111744    
Other Study ID Numbers: PRECAB
First Posted: October 1, 2019    Key Record Dates
Last Update Posted: October 1, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kerckhoff Klinik:
Coronary Artery Bypass Graft Surgery
Physical Activity
Coronary Artery Disease
Physical Training
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases