Preoperative Excercise Training for Patients Undergoing Coronary Artery Bypass Graft Surgery

NCT04111744 | Completed

• 1 other identifier: PRECAB
• Study Type: interventional
• Target: 203
• Locations: 1 country
• Sites: 1

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

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Cardiopulmonary fitness

  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

  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 Outcomes (21)

• Length of hospital stay (LoS)

  Within the acute care period

• Length of ventilation

  Within the acute care period

• Functional capacity

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

• Arterial stiffness

  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

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

Study Arms (2)

Training Group

EXPERIMENTAL

Preoperative Exercise Training Optimal medical therapy,

Other: Preoperative Exercise Training; Other: Optimal medical therapy

Control Group

OTHER

Optimal medical therapy, inactive control group

Other: Optimal medical therapy

Interventions

Preoperative Exercise Training OTHER

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

Training Group

Optimal medical therapy OTHER

Standard medication for stable CAD

Control Group; Training Group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• stable Angina
• indication for elective CABG surgery
• functional capacity \> 50 watts
• willingness to participate in the study

You may not qualify if:

• 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

Sponsors & Collaborators

• Kerckhoff Klinik: lead

Study Sites (1)

Kerckhoff Klinik

Bad Nauheim, 61231, Germany

Location

Related Publications (1)

• 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.

  PMID: 32546065 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Motor Activity

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Behavior

Study Officials

• Claudia Walther, MD

  Kerckhoff Clinic

  PRINCIPAL INVESTIGATOR

• Heike Baumgarten, MD

  Kerckhoff Clinik

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: March 21, 2018
• First Posted: October 1, 2019
• Study Start: January 1, 2015
• Primary Completion: June 30, 2018
• Study Completion: December 31, 2018
• Last Updated: October 1, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)