Cardiac Rehabilitation in Patients With Refractory Angina
Ključne riječi
Sažetak
Opis
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.
Datumi
| Posljednja provjera: | 12/31/2016 |
| Prvo podneseno: | 06/04/2017 |
| Predviđena prijava poslana: | 07/11/2017 |
| Prvo objavljeno: | 07/16/2017 |
| Posljednje ažuriranje poslano: | 07/11/2017 |
| Posljednje ažuriranje objavljeno: | 07/16/2017 |
| Stvarni datum početka studija: | 12/31/2015 |
| Procijenjeni datum primarnog završetka: | 06/20/2017 |
Stanje ili bolest
Intervencija / liječenje
Behavioral: Clinical treatment physical training
Faza
Grupe ruku
| Ruka | Intervencija / liječenje |
|---|---|
| Experimental: Clinical treatment physical training Patients with optimized clinical treatment group that will do physical training for 12 weeks. They will do the tests in moment 1 and after 3 mounths.
The intervention is the Cardiac Rehabilitation. | Behavioral: Clinical treatment physical training 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. |
| No Intervention: Optimized clinical treatment Patients with optimized clinical treatment group that will not do physical training.They will do the tests in moment 1 and after 3 mounths. | |
| No Intervention: Coronary insufficiency without angina Group with coronary insufficiency without angina and will not do physical training. They will do the tests only one moment. | |
| No Intervention: Normal healthy subjects Group normal healthy subjects, without coronary injuries, diabetes, hypertension and another chronic disease. These group have be sedentary and will not do physical training. They will do the tests only one moment. |
Kriterij prihvatljivosti
| Dobni uvjeti za studiranje | 45 Years Do 45 Years |
| Spolovi koji ispunjavaju uvjete za studij | All |
| Prihvaća zdrave volontere | Da |
| Kriteriji | Group 1 and 2 Inclusion Criteria: - Stable angina functional class II to IV according to the classification of Canadian Cardiovascular Society (CCS) 39, or limiting angina in Perception of the patient; - Documented myocardial ischemia by imaging method; - Patients not eligible for myocardial revascularization procedures surgical conventional, due to the unfavorable anatomy; - Signature of the Free and Informed Consent Form. Exclusion Criteria: - Patients with definitive pacemaker or implantable cardioverter defibrillator (ICD); - Patients with non-sinus heart rhythm; - Patients with complete intraventricular block; - Acute coronary syndrome (myocardial infarction or unstable angina) or previous procedures for myocardial revascularization (angioplasty / surgery) less than 3 months; - Functional impossibility (orthopedic, rheumatic, neurological, or otherwise) or social for participation in the Rehabilitation Program; - Classification of risk for American Heart Association class D physical training (unstable ischemia, stenosis or severe or symptomatic valve insufficiency, congenital heart disease, decompensated heart failure, uncontrolled arrhythmias and other conditions that may be aggravated by exercise). Group 3 Inclusion Criteria: - Patients with coronary insufficiency without angina; - Signature of the Free and Informed Consent Form. Group 4 Inclusion Criteria: - Signature of the Free and Informed Consent Form; - Healthy; - Non-smokers; - Sedentary |
Ishod
Primarne mjere ishoda
1. Cardiovascular rehabilitation in patients with refractory angina is safe; [3 months of rehabilitation]
2. Cardiovascular rehabilitation in patients with refractory angina is efficient; [3 months of rehabilitation]
3. Improve the maximal oxygen consumption [3 months of rehabilitation]
4. Improve the global myocardial ischemic load [3 months of rehabilitation]
Sekundarne mjere ishoda
1. Reduction of myocardial injury caused by physical stress [3 months of rehabilitation]
2. Rehabilitation will modulate sympathetic activity [3 months of rehabilitation]
3. Improvement of ventricular function [3 months of rehabilitation]
4. Improvement of the quality of life [3 months of rehabilitation]
5. Rehabilitation will increase muscle blood flow [3 months of rehabilitation]
6. Reduction in the number of symptomatic episodes of ischemia [3 months of rehabilitation]
7. Reduction of the daily consumption of sublingual nitrate [3 months of rehabilitation]
8. Improve the functional class of Refractory Angina [3 months of rehabilitation]
