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Preoperative Excercise Training for Patients Undergoing Coronary Artery Bypass Graft Surgery

Primary Purpose

Coronary Artery Disease, Physical Activity, Coronary Artery Bypass Graft Surgery

Status

Completed

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

Preoperative Exercise Training

Optimal medical therapy

About this trial

This is an interventional prevention trial for Coronary Artery Disease focused on measuring Coronary Artery Bypass Graft Surgery, Physical Activity, Coronary Artery Disease, Physical Training

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Kerckhoff Klinik

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Training Group

Control Group

Arm Description

Preoperative Exercise Training Optimal medical therapy,

Optimal medical therapy, inactive control group

Outcomes

Primary Outcome Measures

Cardiopulmonary fitness

Change of maximal Oxygen consumption

Endothelial function

Change of Reactive hyperemic index (RHI)

Secondary Outcome Measures

Length of hospital stay (LoS)

Duration of hospital stay in days

Length of ventilation

Duration of Ventilation in minutes

Functional capacity

Change of 6-minute walk test

Arterial stiffness

Changes in arterial pulse wave analysis

Quality of life Questionnaire 1

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

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.

Quality of life Questionnaire 3

Changes in Mobility and Self-supply (MOSES) questionnaire

Ischemic blood marker 1

High Sensitive Troponin (hs-Trop)

Ischemic blood marker 2

Creatine kinase (CK) U/L

Ischemic blood marker 3

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

Ischemic blood marker 4

Lactate dehydrogenase (LDH) U/L

Ischemic blood marker 5

glutamic oxaloacetic transaminase (GOT) U/L

Ischemic blood marker 6

glutamate pyruvate transaminase (GPT) U/L

Ischemic blood marker 7

copeptin U/L

Inflammatory blood marker 1

C-reactive protein (CRP) U/L

Inflammatory blood marker 2

Leucozytes 10³/µL

Inflammatory blood marker 3

Interleukine-6 (IL-6) pg/mL

Number of patients with a Clinical Event

Atrial fibrillation documented by electrocardiogram (ECG)

Number of patients with a Pulmonary clinical event

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

Number of patients with a Cardiovascular event

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

Number of patients with a Cerebrovascular event

TIA, stroke

Full Information

NCT ID

NCT04111744

First Posted

March 21, 2018

Last Updated

September 30, 2019

Sponsor

Kerckhoff Klinik

1. Study Identification

Unique Protocol Identification Number

NCT04111744

Brief Title

Preoperative Excercise Training for Patients Undergoing Coronary Artery Bypass Graft Surgery

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2019

Overall Recruitment Status

Completed

Study Start Date

January 1, 2015 (Actual)

Primary Completion Date

June 30, 2018 (Actual)

Study Completion Date

December 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Kerckhoff Klinik

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Artery Disease, Physical Activity, Coronary Artery Bypass Graft Surgery

Keywords

Coronary Artery Bypass Graft Surgery, Physical Activity, Coronary Artery Disease, Physical Training

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Patients enrolled to the study were randomised in a Treatment and a control Group

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

203 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Training Group

Arm Type

Experimental

Arm Description

Preoperative Exercise Training Optimal medical therapy,

Arm Title

Control Group

Arm Type

Other

Arm Description

Optimal medical therapy, inactive control group

Intervention Type

Other

Intervention Name(s)

Preoperative Exercise Training

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Optimal medical therapy

Intervention Description

Standard medication for stable CAD

Primary Outcome Measure Information:

Title

Cardiopulmonary fitness

Description

Change of maximal Oxygen consumption

Time Frame

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

Title

Endothelial function

Description

Change of Reactive hyperemic index (RHI)

Time Frame

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

Secondary Outcome Measure Information:

Title

Length of hospital stay (LoS)

Description

Duration of hospital stay in days

Time Frame

Within the acute care period

Title

Length of ventilation

Description

Duration of Ventilation in minutes

Time Frame

Within the acute care period

Title

Functional capacity

Description

Change of 6-minute walk test

Time Frame