Clinical trial NCT03096158: Cardiac and Endothelial Function Response to Early Exercise Training After Coronary Artery Bypass Surgery
Official title: Cardiac and Endothelial Function Response to Early Exercise Training (CEFREET Study) After Coronary Artery Bypass Surgery: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Bypass Grafting
Coronary Artery Disease
Cardiac Rehabilitation
Keywords: Coronary artery bypass grafting
Cardiorespiratory rehabilitation
Functional electrical stimulation
Inspiratory muscle training
Aerobic training
Isometric handgrip training
Functional capacity
Endothelial function
Cardiac function
Lead sponsor: Instituto de Cardiologia do Rio Grande do Sul
Sponsor class: OTHER
First posted: 2017-03-30
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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
* After the physical training period, individuals who have not completed a minimum of 80% of the protocol will be excluded from the sample due to refusal or withdrawal.

Primary outcomes:
measure: Functional Capacity - Six-Minute Walk Test (6MWT)
timeFrame: Pre and post (7 days) coronary artery bypass surgery
Secondary outcomes:
measure: Cardiac Function - Echocardiography
timeFrame: Pre and post (7 days) coronary artery bypass surgery
measure: Endothelial Function- Flow-Mediated Dilation (FMD)
timeFrame: Pre and post (7 days) coronary artery bypass surgery
measure: Femoral Quadriceps Perimetry
timeFrame: Pre and post (7 days) coronary artery bypass surgery
measure: Maximal Inspiratory Pressure
timeFrame: Pre and post (7 days) coronary artery bypass surgery
measure: Handgrip Strength
timeFrame: Pre and post (7 days) coronary artery bypass surgery
measure: ELISA Immunoassay
timeFrame: Pre and post (7 days) coronary artery bypass surgery
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Bruna Eibel
Study officials:
References:
citation: ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. doi: 10.1164/ajrccm.166.1.at1102. No abstract available.
citation: Thijssen DH, Black MA, Pyke KE, Padilla J, Atkinson G, Harris RA, Parker B, Widlansky ME, Tschakovsky ME, Green DJ. Assessment of flow-mediated dilation in humans: a methodological and physiological guideline. Am J Physiol Heart Circ Physiol. 2011 Jan;300(1):H2-12. doi: 10.1152/ajpheart.00471.2010. Epub 2010 Oct 15.