Preoperative Excercise Training for Patients Undergoing Coronary Artery Bypass Graft Surgery

September 30, 2019 updated by: Kerckhoff Klinik

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
203

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Bad Nauheim, Germany, 61231
        • Kerckhoff Klinik

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Baseline, prior surgery on hospital admission day, hospital discharge day ( postoperative day 7-14) , after 3 weeks of cardiac rehabilitation
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)
Baseline, prior surgery on hospital admission day, hospital discharge day (postoperative day 7-14), after 3 weeks of cardiac rehabilitation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Length of hospital stay (LoS)
Time Frame: Within the acute care period
Duration of hospital stay in days
Within the acute care period
Length of ventilation
Time Frame: Within the acute care period
Duration of Ventilation in minutes
Within the acute care period
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
Baseline, prior surgery on hospital admission day, hospital discharge day(postoperative day 7-14), , after 3 weeks of cardiac rehabilitation
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
Baseline, prior surgery on hospital admission day, hospital discharge day(postoperative day 7-14), , after 3 weeks of cardiac rehabilitation
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
Baseline, prior surgery on hospital admission day, hospital discharge day(postoperative day 7-14), , after 3 weeks of cardiac rehabilitation
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.
Baseline, prior surgery on hospital admission day, hospital discharge day(postoperative day 7-14), , after 3 weeks of cardiac rehabilitation
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
Baseline, prior surgery on hospital admission day, hospital discharge day(postoperative day 7-14), , after 3 weeks of cardiac rehabilitation
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)
Baseline, prior surgery on hospital admission day, hospital discharge day(postoperative day 7-14), , after 3 weeks of cardiac rehabilitation
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
Baseline, prior surgery on hospital admission day, hospital discharge day(postoperative day 7-14), , after 3 weeks of cardiac rehabilitation
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
Baseline, prior surgery on hospital admission day, hospital discharge day(postoperative day 7-14), , after 3 weeks of cardiac rehabilitation
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
Baseline, prior surgery on hospital admission day, hospital discharge day(postoperative day 7-14), , after 3 weeks of cardiac rehabilitation
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
Baseline, prior surgery on hospital admission day, hospital discharge day(postoperative day 7-14), , after 3 weeks of cardiac rehabilitation
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
Baseline, prior surgery on hospital admission day, hospital discharge day(postoperative day 7-14), , after 3 weeks of cardiac rehabilitation
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
Baseline, prior surgery on hospital admission day, hospital discharge day(postoperative day 7-14), , after 3 weeks of cardiac rehabilitation
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
Baseline, prior surgery on hospital admission day, hospital discharge day(postoperative day 7-14), , after 3 weeks of cardiac rehabilitation
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
Baseline, prior surgery on hospital admission day, hospital discharge day(postoperative day 7-14), , after 3 weeks of cardiac rehabilitation
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
Baseline, prior surgery on hospital admission day, hospital discharge day(postoperative day 7-14), , after 3 weeks of cardiac rehabilitation
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)
Baseline, prior surgery on hospital admission day, hospital discharge day(postoperative day 7-14), , after 3 weeks of cardiac rehabilitation
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
Baseline, prior surgery on hospital admission day, hospital discharge day(postoperative day 7-14), , after 3 weeks of cardiac rehabilitation
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
after 30 days and 12 months
Number of patients with a Cerebrovascular event
Time Frame: after 30 days and 12 months
TIA, stroke
after 30 days and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kerckhoff Klinik

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Claudia Walther, MD, Kerckhoff Clinic
  • Principal Investigator: Heike Baumgarten, MD, Kerckhoff Clinik

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 21, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 30, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 1, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 1, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 30, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PRECAB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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