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Clinical Trials/NCT03096158
NCT03096158
Completed
Not Applicable

Cardiac and Endothelial Function Response to Early Exercise Training (CEFREET Study) After Coronary Artery Bypass Surgery: a Randomized Clinical Trial

Instituto de Cardiologia do Rio Grande do Sul1 site in 1 country30 target enrollmentApril 1, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Coronary Artery Bypass Grafting
Sponsor
Instituto de Cardiologia do Rio Grande do Sul
Enrollment
30
Locations
1
Primary Endpoint
Functional Capacity - Six-Minute Walk Test (6MWT)
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

Background: Coronary artery bypass grafting (CABG) due to coronary artery disease (CAD) is one of the main surgical procedures performed in the area of cardiology. Individuals undergoing CABG present sarcopenia, decreased muscle strength of the lower limbs, decreased respiratory muscle strength and dyspnea due to immobility in the bed and the inherent conditions of the disease itself. Cardiorespiratory rehabilitation techniques are rarely used with measurement in hospitals and can greatly favor an early and effective reestablishment to this population in several parameters. Objective: To evaluate the effect of functional electrical stimulation (FES), ventilatory muscle training (TREMVEN), early aerobic training (AERO) and isometric handgrip training (ISO) on the functional capacity, endothelial function and cardiac parameters of individuals undergoing CABG. Methods: In a randomized clinical trial, volunteers will be allocated into four groups: EEF, TREMVEN, AERO or ISO in the preoperative period of CABG. After 48 hours (postoperative midway) of the surgery, the protocol will begin until after hospital discharge. The endpoints evaluated will be: functional capacity, respiratory muscle strength, systolic and diastolic function, arterial endothelial function, inflammatory profile and plasma levels of vascular endothelial growth factor (VEGF). Scientific contributions: Phase 1 cardiorespiratory rehabilitation with alternative interventions may provide an increase in functional capacity, strengthening of respiratory muscles, improvement in cardiac and endothelial functions, as well as increased systemic VEGF levels (myocardial revascularization) and improvement of the inflammatory profile, effectively forwarding the individuals to the rehabilitation phase 2.

Registry
clinicaltrials.gov
Start Date
April 1, 2017
End Date
October 1, 2018
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Instituto de Cardiologia do Rio Grande do Sul
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Be elective for the first CABG due to a previous ischemic event;
  • Do not present other associated heart diseases;
  • Absence of history of neuromuscular, autoimmune and infectious diseases;
  • Age between 50 to 75 years;
  • Signature of the Informed Consent Term.
  • No hyperreactivity during the pre-intervention evaluation tests;
  • No chronic renal failure; history of malignant disease with life expectancy \<2 years;
  • No severe arrhythmias, angina pectoris, pulmonary embolism and thrombophlebitis;
  • Do not have orthopedic limitations or any physical or mental limitation that prevents the proposed exercises from being performed;
  • Present Left Ventricular Ejection Fraction (LVEF) \> 40% in 48h after CABG, and

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Functional Capacity - Six-Minute Walk Test (6MWT)

Time Frame: Pre and post (7 days) coronary artery bypass surgery

The 6MWT will be performed to assess functional capacity following the guidelines proposed by the American Thoracic Society.

Secondary Outcomes

  • Handgrip Strength(Pre and post (7 days) coronary artery bypass surgery)
  • Cardiac Function - Echocardiography(Pre and post (7 days) coronary artery bypass surgery)
  • Endothelial Function- Flow-Mediated Dilation (FMD)(Pre and post (7 days) coronary artery bypass surgery)
  • Femoral Quadriceps Perimetry(Pre and post (7 days) coronary artery bypass surgery)
  • Maximal Inspiratory Pressure(Pre and post (7 days) coronary artery bypass surgery)
  • ELISA Immunoassay(Pre and post (7 days) coronary artery bypass surgery)

Study Sites (1)

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