Preoperative Excercise Training for Patients Undergoing Coronary Artery Bypass Graft Surgery

• Sponsor: Kerckhoff Klinik (Other)
• Overall Status: Completed
• CT.gov ID: NCT04111744
• Collaborator: (none)
• Enrollment: 203
• Location: 1
• Arms: 2
• Actual Duration (Months): 48
• Patients Per Site Per Month: 4.2

Study Details

Study Description

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	N/A

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 Design

• Study Type: Interventional
• 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 GroupPatients 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: Jan 1, 2015
• Actual Primary Completion Date: Jun 30, 2018
• Actual Study Completion Date: Dec 31, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Cardiopulmonary fitness [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 [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) [Within the acute care period]

   Duration of hospital stay in days

2. Length of ventilation [Within the acute care period]

   Duration of Ventilation in minutes

3. Functional capacity [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [after 30 days and 12 months]

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

21. Number of patients with a Cerebrovascular event [after 30 days and 12 months]

    TIA, stroke

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kerckhoff Klinik	Bad Nauheim		Germany	61231

Sponsors and Collaborators

• Kerckhoff Klinik

Investigators

• Principal Investigator: Claudia Walther, MD, Kerckhoff Clinic
• Principal Investigator: Heike Baumgarten, MD, Kerckhoff Clinik

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kerckhoff Klinik
• ClinicalTrials.gov Identifier: NCT04111744
• Other Study ID Numbers: PRECAB
• First Posted: Oct 1, 2019
• Last Update Posted: Oct 1, 2019
• Last Verified: Sep 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease

Study Results

No Results Posted as of Oct 1, 2019