Cardiac Rehabilitation in Patients With Refractory Angina
Condition: Refractory Angina
MeSH terms: Angina Pectoris
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the safety and feasibility of cardiovascular
      rehabilitation in Patients with refractory angina, evaluate the effect of cardiovascular
      rehabilitation in patients with angina Refractory, by maximal oxygen consumption (VO2max) and
      global myocardial ischemic load by Stress Echocardiography; To evaluate the presence of
      myocardial injury, caused by physical stress, through ultra-sensitive troponin after sessions
      of aerobic physical activity, evaluating the behavior during the training period; To evaluate
      the effect of rehabilitation on the modulation of sympathetic activity and inflammation,
      muscular blood flow and lipid metabolism; To evaluate of the effect of rehabilitation on
      ventricular function through Stress echocardiography; Detection of ischemic episodes and
      arrhythmias identified during the Rehabilitation sessions through external cardiac monitoring
      (telemetry); Evaluate the quality of life assessment through the SF-36 questionnaire,
      Canadian Cardiovascular Society, the number of symptomatic episodes of ischemia, daily
      sublingual nitrate intake.
    

Detailed description: 
      After signing the informed consent form, patients will be randomized into 4 groups: 1.
      Optimized clinical treatment group + physical training for 12 weeks (TF); 2. optimized
      clinical treatment group (CT); 3. Group with coronary insufficiency without angina (CD);
      Group 4: normal healthy subjects All patients will be submitted to the following procedures
      in 2 moments * (times 0 and 3): -Routine laboratory tests including study of total
      cholesterol, LDL-cholesterol, -HDL-cholesterol, including study of the functionality of
      HDL-c, triglycerides, complete blood count, renal function, fasting glycemia, glycosylated
      hemoglobin (HbA1C); - Dosage of biomarkers of myocardial ischemia (ultra-sensitive troponin);
      - Dosage of inflammatory markers: Tumor necrosis factor (TNFn), interleukins 1 and 6 (IL-1
      and IL-6), ultra-sensitive C-reactive protein (CRP); - Vascular endothelial growth factor
      (VEGF) dosage; - ergospirometric test in cycloergometer; - Echocardiogram with physical
      stress with evaluation of myocardial perfusion and function; - Evaluation of sympathetic
      activity through microneurography; - Evaluation of vascular reactivity through ultrasound of
      the brachial artery. - Evaluation of muscular blood flow through plethysmography; - Isometric
      exercise protocols; - Mental stress protocol - Quality of Life Questionnaire; - Diary of
      angina. After the initial examinations, the candidates of the TF group will be evaluated by
      cardiovascular rehabilitation team, for training prescription, which will be performed in a
      hospital environment, supervised by a qualified doctor. The rehabilitation may be interrupted
      in any patient, for safety measure, if the investigator deems it appropriate. All patients in
      both groups will receive clinical follow-up during the protocol, with monthly consultations
      during the 12-week protocol period (time 0 to 3), in which clinical evaluations of symptoms
      and quality of life of the patients will be performed . Any clinical intercurrence will be
      promptly annotated and evaluated according to the need of the moment. After this period,
      routine outpatient follow-up is scheduled at the outpatient clinic, and counseling for
      unsupervised physical training, according to the results of the study. All laboratory,
      clinical, imaging, and functional parameters will be evaluated before and at the end of the
      protocol.
    

Intervention name(s): Cardiac Rehabilitation
Intervention type(s): Behavioral
Intervention description(s): The physical training program will start shortly after the initial exams have been completed. The physical training protocol will consist of a 12-week duration, with a frequency of 3 weekly sessions of 60 minutes duration each. The intensity will be prescribed from the echocardiogram with effort and cardiopulmonary test. All sessions will be monitored by telemetry and will be distributed as follows:
5 minutes warm up
30 to 40 minutes of aerobic exercise (treadmill). The training intensity will be prescribed individually, based on the results of the test results;
10 minutes of localized exercises;
5 minutes of relaxation.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Optimized clinical treatment group + physical training for 12 weeks (TF);
optimized clinical treatment group (CT);
Group with coronary insufficiency without angina (CD);
Group normal healthy subjects
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Refractory Angina; Rehabilitation