Effectiveness of Stratification Protocols and Clinical, Physical and Biochemical Parameters to Forecast Intercurrences in Cardiovascular Rehabilitation Programs.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 72
- 主要终点
- Autonomic modulation
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Autonomic modulation
时间窗: 6 months
The autonomic modulation will be evaluated by heart rate variability method
Blood pressure
时间窗: 6 months
The blood pressure will be evaluated with a non invasive method
Heart rate
时间窗: 6 months
The heart rate will be evaluated with an pulse oximeter with the volunteers at rest
Spirometric parameters
时间窗: 6 months
The spirometric parameters will be evaluated by spirometry method.
Maximum expiratory and inspiratory pressure
时间窗: 6 months
The maximum expiratory and inspiratory pressure will be evaluated by manovacuometry method.
maximum isometric muncle strength
时间窗: 6 months
The vollunteers will realize the maximum isometric strength with a dominant member during 5 seconds, and the maximum value obtained will be registered.
voluntary isometric contraction
时间窗: 6 months
The volunteers will do a maximum voluntary isometric contraction and instructed to maintain this contraction as longer they can. The maximum time obtained will be registered.
Cardiorrespiratory fitness
时间窗: 6 months
The vollunters will be submited to a maximum effort test to define their cardiorrespiratory fitness.
Physical activity level
时间窗: 6 months.
The physical activity of the volunteers will be registered during one week to determine their physical activity level.
Biochemical parameters
时间窗: 6 months
Inflamatory (TNF-alpha, IL-6) and anti-inflamatory cytokines (IL-10) will be analysed by blood samples.
Cardiovascular risk stratification protocols
时间窗: 2 months
The cardiovascular risk stratification will be evaluated by seven diferent protocols and the volunteers will be stratified like less, medium and high cardiovascular risk. There will be used protocols of the organizations below: American College of Sports Medicine, Sociedade Brasileira de Cardiologia, American Heart Association, Frederic J. Pashkow protocol, American Association of Cardiovascular and Pulmonary Rehabilitation, Société Française de Cardiologie and Sociedad Española de Cardiología
Cardiovascular signals
时间窗: 6 months
Signals like pulse rate changes, increased SBP and DBP during exercise, tachipnea, pallor will be observed by the evaluator and the presence or absence will be registered.
Cardiovascular symptoms
时间窗: 6 months
Symptoms like dizziness, angina pectoris, cramp, muscle pain, fatigue, nausea will be related for the volunteers, and the presence or absence will be registered.
次要结局
- oxygen saturation(6 months)
- Respiratory frequency(6 months)
研究者
Luiz Carlos Marques Vanderlei
PhD
Universidade Estadual Paulista Júlio de Mesquita Filho
