NCT03096158

Cardiac and Endothelial Function Response to Early Exercise Training After Coronary Artery Bypass Surgery

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Instituto de Cardiologia do Rio Grande do Sul · Academic / Other
• Sex: All
• Age: 50 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Coronary Artery Bypass Grafting
• Coronary Artery Disease
• Cardiac Rehabilitation

Interventions

Type	Name	Description
OTHER	Ventilatory Muscle Training (TREMVEN)	Early cardiac rehabilitation after coronary artery bypass graft: The enrolled participants will perform IMT or P-IMT for 20 minutes during the period of hospitalization, using the Power Breathe device (POWERbreathe International LTD). During training, subjects will be instructed to maintain diaphragmatic breathing at a rate at 15 to 20 breaths/min. The inspiratory load will be set at 30% of maximal static inspiratory pressure (PImax). It will be occur once per day until the hospital exit.
OTHER	Aerobic Training (AERO)	Early cardiac rehabilitation after coronary artery bypass graft: It will consist of supervised walking, lasting 20 minutes a day, during the period of hospitalization of the participants. Heart rate (HR) will be constantly monitored through a cardiac monitor (Polar), with the objective of maintaining between 50 and 60% of the maximum HR predicted by age; Similar to 40 to 50% of VO2max. Blood pressure, SpO2 and level of dyspnea (Borg's effort perception scale) will also be monitored constantly. It will be occur once per day until the hospital exit.
OTHER	Isometric Handgrip Training (ISO)	Early cardiac rehabilitation after coronary artery bypass graft: Study participants will perform 5 x 2 min alternating bilateral contractions of the hand flexor muscles at 30% maximum voluntary contraction with one minute rest between contractions, in a total of 20 minutes training during the period of hospitalization. It will be occur once per day until the hospital exit.

Timeline

• Start date: 2017-04-01
• Primary completion: 2018-10-01
• Completion: 2018-10-01
• First posted: 2017-03-30
• Last updated: 2019-08-07

Locations

1 site across 1 country: Brazil