Preoperative Excercise Training for Patients Undergoing Coronary Artery Bypass Graft Surgery

NCT ID: NCT04111744

Last Updated: 2019-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

203 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-01

Study Completion Date

2018-12-31

Brief Summary

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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

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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.

Conditions

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Coronary Artery Disease Physical Activity Coronary Artery Bypass Graft Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Training Group

Preoperative Exercise Training Optimal medical therapy,

Group Type EXPERIMENTAL

Preoperative Exercise Training

Intervention Type OTHER

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

Optimal medical therapy

Intervention Type OTHER

Standard medication for stable CAD

Control Group

Optimal medical therapy, inactive control group

Group Type OTHER

Optimal medical therapy

Intervention Type OTHER

Standard medication for stable CAD

Interventions

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Preoperative Exercise Training

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

Intervention Type OTHER

Optimal medical therapy

Standard medication for stable CAD

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kerckhoff Klinik

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Claudia Walther, MD

Role: PRINCIPAL_INVESTIGATOR

Kerckhoff Clinic

Heike Baumgarten, MD

Role: PRINCIPAL_INVESTIGATOR

Kerckhoff Clinik

Locations

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Kerckhoff Klinik

Bad Nauheim, , Germany

Site Status

Countries

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Germany

References

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Steinmetz C, Bjarnason-Wehrens B, Baumgarten H, Walther T, Mengden T, Walther C. Prehabilitation in patients awaiting elective coronary artery bypass graft surgery - effects on functional capacity and quality of life: a randomized controlled trial. Clin Rehabil. 2020 Oct;34(10):1256-1267. doi: 10.1177/0269215520933950. Epub 2020 Jun 16.

Reference Type DERIVED
PMID: 32546065 (View on PubMed)

Other Identifiers

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PRECAB

Identifier Type: -

Identifier Source: org_study_id

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