An interventional study of Ventilatory Muscle Training (TREMVEN) and Aerobic Training (AERO) in Coronary Artery Bypass Grafting, Coronary Artery Disease and Cardiac Rehabilitation, sponsored by Instituto de Cardiologia do Rio Grande do Sul. Completed at 1 site in Brazil. Open to participants aged 50 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-08-07.
Sponsored by Instituto de Cardiologia do Rio Grande do Sul · Not applicable, Interventional, and Treatment
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.
5,598 studies on the registry are indexed under Coronary Artery Disease; 955 are open to participants now.
This study's enrollment of 30 is below the median of 123 across 3,435 interventional studies indexed under Coronary Artery Disease.
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Inclusion Criteria:
The enrolled participants will perform inspiratory muscle training (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: Ventilatory Muscle Training (TREMVEN)
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, oxygen saturation (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: Aerobic Training (AERO)
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.
Other: Isometric Handgrip Training (ISO)
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.
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.
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.
Functional Capacity - Six-Minute Walk Test (6MWT)
The 6MWT will be performed to assess functional capacity following the guidelines proposed by the American Thoracic Society.
Time frame: Pre and post (7 days) coronary artery bypass surgery
Cardiac Function - Echocardiography
A high resolution ultrasound device equipped with a 2-5 megahertz (MHz) transducer will be used to obtain two-dimensional echocardiographic parameters: left ventricular end-diastolic volume, left ventricular end-systolic volume, left ventricular ejection fraction (cardiac function). The images will be stored on the hard disk of the echocardiographic device and analyzed offline in specific software of the equipment itself.
Time frame: Pre and post (7 days) coronary artery bypass surgery
Endothelial Function- Flow-Mediated Dilation (FMD)
To examine brachial artery FMD, the arm will be extended and positioned at an angle of \~80° from the torso. A rapid inflation and deflation pneumatic cuff will be positioned on the forearm to provide an ischemia. A 10-MHz multi-frequency linear array probes, attached to a high resolution ultrasound machine, will be then used to image the brachial artery in the distal 1⁄3rd of the upper arm. Following baseline assessments, the forearm cuff will be inflated ( \> 200 mmHg) for 5 minutes. Diameter and flow recordings resumed 30s prior to cuff deflation and continued for 3 minutes.
Time frame: Pre and post (7 days) coronary artery bypass surgery
Femoral Quadriceps Perimetry
Quadriceps perimetry will be measured every 5 cm, starting from the top edge of the patella in the proximal direction. Thus, measurements of 5, 10, 15 and 20 cm will be performed in both lower limbs.
Time frame: Pre and post (7 days) coronary artery bypass surgery
Maximal Inspiratory Pressure
Inspiratory muscle function testing will be performed using a pressure transducer (MVD-300), connected to a system with two unidirectional valves. PImax will be determined in deep inspiration from residual volume against an occluded airway with a minor air leak (2 mm). The highest pressure of six measurements (with less than 5% difference) will be used to define PImax.
Time frame: Pre and post (7 days) coronary artery bypass surgery
Handgrip Strength
A digital handgrip device will be held while sitting upright in a chair with feet flat on the floor and 5 maximal contractions of the hand flexor muscles with each hand will be performed to determine maximum voluntary contraction (MVC). 30% of MVC will be used to isometric handgrip resistance exercise.
Time frame: Pre and post (7 days) coronary artery bypass surgery
ELISA Immunoassay
A venous blood sample will be collected pre- and post-intervention. After centrifugation at 1.000 rpm for 10 min at 4 C, the plasma will be separated and stored at 80 C until assay. VEGF and inflammatory markers will be analyzed.
Time frame: Pre and post (7 days) coronary artery bypass surgery
Plan to share: No
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Instituto de Cardiologia do Rio Grande do Sul