Clinical Trials Logo

Clinical Trial Summary

INTRODUCTION: Cardiovascular diseases are the main causes of death in Brazil and in the world, associated with a large number of people with physical disabilities and disability, significantly burdening public health expenditures. Some patients end up having the need to do cardiac surgeries. , and consequently suffer complications associated with the surgical process due to prolonged rest in the bed, and complications are directly related to the morbidity and mortality rate in these patients. Thus, cardiac rehabilitation has great scientific evidences that directly impacts functional capacity, quality of life and thus reducing the morbimortality rate of these patients. However, it is worth noting that there is no outpatient cardiovascular rehabilitation service linked to the single health system (SUS) in the Amazon Region, that is, involving phase III of cardiac rehabilitation with defined and structured protocols for the group of patients already mentioned. OBJECTIVE: To analyze the clinical evolution of patients in the postoperative period of coronary artery bypass grafting and / or valve replacement (phase III), in outpatient treatment. METHODOLOGY: It is a a longitudinal study, with quantitative variables to be performed in a single center within a year (12 months). Which will evaluate the effects of phase III cardiac rehabilitation of patients undergoing cardiac surgery through an evaluation, which will evaluate heart rate variability, functional capacity by six-minute walk test, pulmonary volumes and capacities by spirometry, percutaneous strength and ventilatory muscle, MRC scale and manovacuometry, respectively, and the application of a quality of life assessment questionnaire. Subsequently, the protocol of 20 sessions will be applied and at the end the same variables will be re-evaluated. EXPECTED RESULTS: It is expected from the application of this research that the protocol suggested for the phase III cardiac rehabilitation of patients submitted to cardiac surgery will bring benefits to patients, such as improvement in heart rate variability, improvement in functional capacity, improvement in quality of life, and reduction in morbidity and mortality rates.


Clinical Trial Description

Characterized by the insufficiency of blood supply to the heart through the coronary arteries, coronary artery disease (CAD) stands out as a global health problem, since it represents the main cause of morbidity and mortality and is among the pathologies with the greatest clinical and significantly increasing public health expenditures. In Brazil, it is estimated that CAD corresponds to 80% of deaths due to cardiovascular diseases (CVD), mainly in large centers and in the population with age over 40 years. CAD is associated with risk factors such as systemic arterial hypertension, smoking, dyslipidemia, obesity, diabetes mellitus, sedentary lifestyle, and in addition to the family history of coronary insufficiency, that favors its onset.

The process of treatment of CAD is variable according to the level of involvement, and can be performed through drugs, physical activities, nutritional control and surgical procedure. Cardiac surgery is an alternative to promote improvement of cardiovascular function in addition to reduction of morbimortality rates due to circulatory diseases, only performed when clinical treatment is not able to provide cure and / or improvement of patient's quality of life. Myocardial revascularization (CABG) surgery is one of the most accomplished cardiac surgeries in Brazil, and it is currently recognized as a well-established procedure for the treatment of CAD, since it is capable of prolonging and improving the quality of life of these patients.

CABG aims at the resolution of myocardial ischemia, seeking the relief of symptoms and consequently improvement of patient survival, biopsychosocial well-being, as well as the earlier return to their daily activities, however, because it is an invasive procedure and complexity, can imply several systemic repercussions such as cardiac, renal, infectious, motor and pulmonary alterations. The postoperative complications of CABG depend on factors related to the clinical situation at the time of surgery, such as age, life habits, comorbidities, and also factors associated with the surgical process, such as duration of surgery, use of extracorporeal circulation, schedules and the long-term invasive mechanical ventilation and hospitalization.

Respiratory complications after CABG contribute to the reduction of the patients' quality of life and increased morbimortality rates. Decreased respiratory muscle strength may be a result of respiratory muscle injury during surgery and / or secondary to diaphragmatic dysfunction due to phrenic nerve injury. Respiratory muscle weakness may compromise the ventilation structure and function of these patients, exacerbating dyspnea, effort intolerance, decreased ability to perform physical exercise, and consequently reduced functional capacity (FC) of the individuals. The FC has a direct impact on the performance of activities of daily living (ADLs), and in this context, the practice of physical exercise after cardiac surgery is essential in the functional recovery of patients.

Cardiovascular rehabilitation (CVR) has a "1" level of recommendation and "A" grade of scientific evidence, and physiotherapy has been the main component in this process, being strongly associated with increased exercise capacity, improved dyspnea, quality of life, as well as a decrease in mortality and morbidity rates, leading to an increase in the life expectancy of these patients in the postoperative period .

Despite the well-known benefits of CVR, the number of patients participating in this program is considered small, only 34% of the candidates are targeted and in the end, only 20% of these candidates participate. In addition, as regards Phase IV rehabilitation, health management of patients is still limited as improvements in lifestyle behavior are often not maintained in the long run and levels of physical activity generally decline after a program of successful outpatient rehabilitation, resulting in the loss of adaptations acquired as a result of physical training. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03771573
Study type Interventional
Source Universidade Metodista de Piracicaba
Contact
Status Completed
Phase N/A
Start date September 1, 2018
Completion date July 20, 2020

See also
  Status Clinical Trial Phase
Recruiting NCT05650307 - CV Imaging of Metabolic Interventions
Recruiting NCT05654272 - Development of CIRC Technologies
Recruiting NCT04515303 - Digital Intervention Participation in DASH
Completed NCT04056208 - Pistachios Blood Sugar Control, Heart and Gut Health Phase 2
Recruiting NCT04417387 - The Genetics and Vascular Health Check Study (GENVASC) Aims to Help Determine Whether Gathering Genetic Information Can Improve the Prediction of Risk of Coronary Artery Disease (CAD)
Not yet recruiting NCT06032572 - Evaluation of the Safety and Effectiveness of the VRS100 System in PCI (ESSENCE) N/A
Recruiting NCT04514445 - The BRAVE Study- The Identification of Genetic Variants Associated With Bicuspid Aortic Valve Using a Combination of Case-control and Family-based Approaches.
Enrolling by invitation NCT04253054 - Chinese Multi-provincial Cohort Study-Beijing Project
Completed NCT03273972 - INvestigating the Lowest Threshold of Vascular bENefits From LDL Lowering With a PCSK9 InhibiTor in healthY Volunteers N/A
Completed NCT03680638 - The Effect of Antioxidants on Skin Blood Flow During Local Heating Phase 1
Recruiting NCT04843891 - Evaluation of PET Probe [64]Cu-Macrin in Cardiovascular Disease, Cancer and Sarcoidosis. Phase 1
Completed NCT04083846 - Clinical Study to Investigate the Pharmacokinetic Profiles and Safety of High-dose CKD-385 in Healthy Volunteers(Fed) Phase 1
Completed NCT04083872 - Clinical Study to Investigate the Pharmacokinetic Profiles and Safety of Highdose CKD-385 in Healthy Volunteers(Fasting) Phase 1
Completed NCT03466333 - Postnatal Enalapril to Improve Cardiovascular fUnction Following Preterm Pre-eclampsia Phase 2
Completed NCT03619148 - The Incidence of Respiratory Symptoms Associated With the Use of HFNO N/A
Completed NCT03693365 - Fluid Responsiveness Tested by the Effective Pulmonary Blood Flow During a Positive End-expiratory Trial
Completed NCT04082585 - Total Health Improvement Program Research Project
Completed NCT05132998 - Impact of a Comprehensive Cardiac Rehabilitation Program Framework Among High Cardiovascular Risk Cancer Survivors N/A
Completed NCT05067114 - Solutions for Atrial Fibrillation Edvocacy (SAFE)
Completed NCT04098172 - Evaluate the Performance and Safety of Comet Pressure Guidewire in the Measurement of FFR N/A