Stratification Protocols and Clinical, Physical and Biochemical Parameters to Forecast Cardiovascular Intercurrences.

Universidade Estadual Paulista Júlio de Mesquita Filho

Status: Unknown

Conditions: Cardiovascular Diseases; Cardiovascular Risk Factor

Treatments: Other: Cardiovascular rehabilitation

Study type: Observational

Funder types: Other

Identifiers

NCT03446742

79213417.0.0000.5402

Details and patient eligibility

About

Introduction: Despite the various beneficial effects, cardiovascular rehabilitation programs (CVRP) have been associated with the appearance of signs and symptoms. Risk stratification protocols are used to stratify into risk trials for an occurrence of events during physical exercise, although studies investigating their efficacy in predicting signs and symptoms during VCTV are inconclusive. In addition, several clinical, physical and biochemical parameters have been used in the literature as risk markers for the appearance of adverse events, and to investigate whether these parameters are capable of predicting a possibility of intercurrences during PRCV sessions.Objectives: 1) to evaluate the efficacy of risk stratification protocols in predicting signs and symptoms during the performance of a PRCV; 2) to analyze the correlation between clinical, physical and biochemical parameters measured at rest with the presence of signs / symptoms in participants of a PRCV; 3) to evaluate whether changes in clinical, physical or biochemical parameters induced by PRCV influence the appearance of signs and symptoms during PRCV. Materials and Methods: To perform this study, data from 70 patients inserted in a PRCV will be evaluated. The study will be divided into three subprojects that can be divided into three stages: 1) risk stratification of patients who will participate in the study by two independent evaluators (Study 1) and evaluation of clinical parameters (cardiorespiratory parameters and autonomic modulation evaluation); (maximal isometric resistance, maximal isometric contraction, functional capacity and level of physical activity) and biochemical (IL-6, TNF-alpha and IL-10) (Studies 2 and 3). Patients will then be followed up by 24 sessions during the PRCV routines to evaluate signs and symptoms, for posterior correlation with the risk stratification obtained in each protocol (Study 1), and with resting values of clinical, physical and biochemical studies (Studies 2 and 3); 2) Patients perform the normal routines of their PRCV for a period of 6 months (Study 3); 3) The patients will again have their clinical, physical and biochemical parameters evaluated and then will be followed up for another 2 months (24 sessions) during the routines of the PRCV sessions to evaluate signs and symptoms, which will allow to evaluate if gains / losses in these parameters exert influence on the appearance of signs and symptoms during PRCV sessions.

Enrollment: 72 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• To present clinical diagnosis of cardiovascular disease and/or cardiovascular risk factors;
• Be able to perform all the proposed evaluations;
• Agree to participate in the studies.

Exclusion criteria

• Patients who miss more than six consecutive sessions of the program or those who total more than 12 absences during the two months that total the period of analysis of the signs and symptoms will be excluded from the analyzes.

Trial design

72 participants in 1 patient group

Cardiovascular rehabilitation group

Description:

Initially all patients will have their charts analyzed, from which data will be extracted for characterization of the population, and anthropometric data will be measured for calculation of body mass index. Afterwards, patients will have their clinical, physical and biochemical parameters. They will be followed up for a period of 2 months during the routines of the cardiovascular rehabilitation sessions for assessment of signs and symptoms. In the second stage the patients will perform the normal routines of their cardiovascular rehabilitation program for a period of 6 months. In the third stage, patients will have their clinical, physical and biochemical parameters and then followed up for another 2 months during the routines of the sessions of the cardiovascular rehabilitation program to evaluate signs and symptoms, which will allow to evaluate if gains/losses in the physical parameters can exert influences in the appearance of signs and symptoms during the sessions.

Treatment:

Other: Cardiovascular rehabilitation