Rehabilitation With Exercises in Cardiovascular Diseases

Study Overview
=================
Brief 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.

Detailed 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.

Official Title
-----------------
Physical Therapy in Rehabilitation Program on Cardiovascular Diseases

Conditions
-----------------
Cardiovascular Diseases

Intervention / Treatment
-----------------
* Other: Physical exercise
* Other: monitoring


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing cardiac surgery; Both sexes and age group between 40 and 70 years; Who were discharged from ambulatory; That they agree to participate in the survey Exclusion Criteria: Patients with Osteomioarticular diseases in upper and lower limbs and neurological diseases that may interfere with the performance of the exercises proposed in the protocol. Female patients in the climacteric. Patients with cardiovascular diseases such as uncontrolled arterial hypertension, arrhythmias that use cardiac pacemakers, infectious diseases that affect the cardiovascular system such as Chagas disease, Heart Failure and / or patients with diabetes mellitus. With simultaneous lung diseases, such as asthma, COPD, collagen diseases (eg, scleroderma) and sarcoidosis. Occupational diseases, such as pneumoconiosis, hypersensitivity pneumonia.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: BLINDED AND RANDOMIZED CLINICAL TRIAL
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Home based intervention<br>will be submitted to a total of 24 sessions of an unsupervised Cardiovascular Physical Therapy protocol, composed of the following steps: warm up, proper training (aerobic training + muscle training for upper and lower limbs with theraband in 5 series with 10 repetitions) often three times a week for eight weeks. | Other: Physical exercise<br>* Participants will perform physical exercises with constant, or intermittent professional supervision or will interrupt the exercise after ambulatorial physical therapy<br>|
| Placebo Comparator: Control group<br>Will not be submitted to the Cardiovascular Physiotherapy Rehabilitation protocol for unsupervised domiciliary, only monitorization of cardiovascular variables. | Other: monitoring<br>* the patients will be under monitoring to investigate the evolution of the disease<br>|
| Active Comparator: Professional seupervision based<br>eight weeks of supervised activities by professional. Each day and for 20 days (20 sessions), volunteers will undergo exercises on cycle ergometer during 30 minutes for upper and lower limbs | Other: Physical exercise<br>* Participants will perform physical exercises with constant, or intermittent professional supervision or will interrupt the exercise after ambulatorial physical therapy<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rate variability | For the collection, the patients will be placed in the supine position and kept at rest for 10 minutes to stabilize the vital signs, after which HR and RR intervals (iR-R) will be recorded, with a duration of 10 minutes. Patient oriented not to perform movements and not to talk during the collection period. The recording of the VFC will be performed by means of a POLAR® brand, RS800CX (Polar Electro TM, Kempele, Finland), where the HR signal will be picked up by a strap with the signal receiver placed in the patient's chest at the time of the xiphoid process of the sternum. The data recorded by the frequency meter will be transferred to the Polar ProTrainer® Software via an infrared signal emitting interface, where it will be stored and subsequently exported in .txt format. The data obtained will be compared before and after the completion of the cardiovascular rehabilitation protocol in the control and intervention groups, among the same. | during 3 months | 
| Respiratoey muscle strenght | Respiratory muscle strength is evaluated with a digital manovacuometer. The patient in the seated position and using a nasal clip performs up to eight maximal inspiration and expiration maneuvers. Measurement of MIP occurs as follows: a nasal clip is used to prevent air from escaping through the nostrils and patients are instructed to place the connection mouthpiece to the manometer, then it is required to empty the lungs. The highest recorded value is the one used for the analysis. In order to measure PEmáx, the patient is asked to fill the air lungs as far as possible to the CPT, making a forced inspiration, and then, with the nasal clip and the manovacuometer connection nozzle correctly positioned, to perform an expiration up to the VR level, held for one second. This maneuver is also performed three times and its values were recorded by the equipment. | during 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
REHABILITATION, PHYSICAL THERAPY, CARDIOVASCULAR DISEASE