Exercise Tolerance in Patients With CABG and Sternotomy vs. Patients With Minimally Invasive Coronary Surgery

Completed

• Conditions: Coronary Artery Bypass Surgery
• Interventions: Other: Cardiopulmonary exercise test

• Registration Number: NCT02433951
• Lead Sponsor: Hasselt University

Brief Summary

In this study, up to 20 healthy individuals, 20 endo-ACAB patients, and 20 CABG patients undergo a maximal cardiopulmonary exercise test after hospital discharge (for patients only). Exercise tolerance is compared between groups.

Detailed Description

In this prospective observational study, up to 20 healthy individuals (no history or presence of any chronic disease, sedentary), 20 endo-ACAB patients, and 20 CABG patients (matched for age, gender and BMI) undergo a maximal cardiopulmonary exercise test after hospital discharge (for patients only).During this exercise test, following parameters are assessed at peak effort and at the second ventilatory threshold (determined by VE/VCO2 slope method): oxygen uptake (VO2), oxygen saturation (SaO2), carbon dioxide output (VCO2), resoiratory gas exchange ratio (RER), expiratory volume (VE), ventilatory equivalent for VCO2 (VE/VCO2), ventilatory equivalent for VO2 (VE/VO2), end-tidal O2 pressure (PETO2), end-tidal CO2 pressure (PETCO2), heart rate (HR), oxygen pulse (VO2/HR), cycling power output (W), tidal volume (Vt), respiratory rate (RR), systolic blood pressure (SBP), diastolic blood pressure (DBP), rate pressure product (RPP). Peak exercise effort is validated by RERpeak.

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-04-24
• Study First Submitted QC: 2015-04-29
• Study First Posted: 2015-05-05
• Primary Completion: 2015-06
• Study Completion: 2015-07
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-17
• Last Update Posted: 2015-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

• undergoing this type of surgery. For healthy subjects: must be sedentary.

Exclusion Criteria

• any neurologic, nephrologic, respiratory disease. For healthy subjects: any chronic disease or condition.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
endo-ACAB patients	Cardiopulmonary exercise test	Age, gender and BMI matched endo-ACAB patients without neurologic, nephrologic, respiratory disease.
healthy individuals	Cardiopulmonary exercise test	Age, gender and BMI matched healthy subjects without any chronic disease or physical disability, and being sedentary.
CABG patients	Cardiopulmonary exercise test	Age, gender and BMI matched CABG patients, without neurologic, nephrologic, respiratory disease.

Primary Outcome Measures

Name	Time	Method
VO2peak (peak oxygen uptake)	At peak exercise, single measurement which is executed between 2-4 weeks after surgery.	Peak oxygen uptake capacity, expressed as ml/min.

Trial Locations

Locations (1)

Jessa Hospital; 🇧🇪 Hasselt, Belgium