Stratification Protocols and Clinical, Physical and Biochemical Parameters to Forecast Cardiovascular Intercurrences.
2018年3月8日 更新者:Luiz Carlos Marques Vanderlei、Universidade Estadual Paulista Júlio de Mesquita Filho
Effectiveness of Stratification Protocols and Clinical, Physical and Biochemical Parameters to Forecast Intercurrences in Cardiovascular Rehabilitation Programs.
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.
研究概览
研究类型
观察性的
注册 (预期的)
72
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
是的
有资格学习的性别
全部
取样方法
非概率样本
研究人群
Individuals, regardless of gender, who participate in the cardiovascular rehabilitation program developed at the Center for Studies and Attendance in Physiotherapy and Rehabilitation of the São Paulo State University.
描述
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.
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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Cardiovascular rehabilitation group
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.
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The cardiovascular rehabilitation program is performed three times weekly on alternate days and each session lasts approximately 60 minutes divided as follows: 5 minutes to the initial rest where blood pressure (BP), heart rate (HR) and signs and symptoms are assessed; 15 minutes of warm-up, composed by global stretches, lower and upper limb exercises, and exercises combining the two modes; then, patients go to the resistance phase (30 minutes), where are performed an individualized aerobic protocol according to their HR reserve values using bicycle and treadmill (at the 4th and 10th minute of both ergometers at HR is evaluated, and in the bicycle is also evaluated the BP of all the patients).
The end of the protocol is composed of 10-minute relaxation, during which the patients perform a small cardiovascular deceleration (a few laps around the room, with free speed) and, finally, lie down at rest.
The presence of signs and symptoms is assessed at all stages of the program.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Autonomic modulation
大体时间:6 months
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The autonomic modulation will be evaluated by heart rate variability method
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6 months
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Blood pressure
大体时间:6 months
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The blood pressure will be evaluated with a non invasive method
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6 months
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Heart rate
大体时间:6 months
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The heart rate will be evaluated with an pulse oximeter with the volunteers at rest
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6 months
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Spirometric parameters
大体时间:6 months
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The spirometric parameters will be evaluated by spirometry method.
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6 months
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Maximum expiratory and inspiratory pressure
大体时间:6 months
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The maximum expiratory and inspiratory pressure will be evaluated by manovacuometry method.
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6 months
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maximum isometric muncle strength
大体时间:6 months
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The vollunteers will realize the maximum isometric strength with a dominant member during 5 seconds, and the maximum value obtained will be registered.
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6 months
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voluntary isometric contraction
大体时间:6 months
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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.
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6 months
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Cardiorrespiratory fitness
大体时间:6 months
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The vollunters will be submited to a maximum effort test to define their cardiorrespiratory fitness.
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6 months
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Physical activity level
大体时间:6 months.
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The physical activity of the volunteers will be registered during one week to determine their physical activity level.
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6 months.
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Biochemical parameters
大体时间:6 months
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Inflamatory (TNF-alpha, IL-6) and anti-inflamatory cytokines (IL-10) will be analysed by blood samples.
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6 months
|
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Cardiovascular risk stratification protocols
大体时间:2 months
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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
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2 months
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Cardiovascular signals
大体时间:6 months
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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.
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6 months
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Cardiovascular symptoms
大体时间:6 months
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Symptoms like dizziness, angina pectoris, cramp, muscle pain, fatigue, nausea will be related for the volunteers, and the presence or absence will be registered.
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6 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
oxygen saturation
大体时间:6 months
|
The respiratory parameter oxigen saturation of the volunteers will be evaluated with a pulse oximeter with the volunteers at rest.
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6 months
|
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Respiratory frequency
大体时间:6 months
|
The respiratory parameters respiratory frequency will the evaluated by number of tract per minute with the volunteers at rest.
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6 months
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 研究主任:Luiz Carlos M Vanderlei, PhD、Universidade Estadual Paulista - UNESP campus de Presidente Prudente
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Ribeiro F, Takahashi C, Vanzella LM, Laurino MJL, Lima IM, Silva VEDS, Silva JPLN, Valente HB, da Silva AKF, Christofaro DGD, Vanderlei LCM. An investigation into whether cardiac risk stratification protocols actually predict complications in cardiac rehabilitation programs? Clin Rehabil. 2021 May;35(5):775-784. doi: 10.1177/0269215520978499. Epub 2020 Dec 8.
- Vanzella LM, Takahashi C, Ribeiro F, Lima IM, Silva AKFD, Christofaro DGD, Vanderlei LCM. Efficacy of risk stratification protocols and clinical, physical, and biochemical parameters to previse signals and symptoms during cardiovascular rehabilitation programs: Protocol for an observational trial. Medicine (Baltimore). 2019 Jun;98(24):e15700. doi: 10.1097/MD.0000000000015700.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (预期的)
2018年3月10日
初级完成 (预期的)
2018年9月30日
研究完成 (预期的)
2019年2月1日
研究注册日期
首次提交
2018年1月29日
首先提交符合 QC 标准的
2018年2月20日
首次发布 (实际的)
2018年2月27日
研究记录更新
最后更新发布 (实际的)
2018年3月12日
上次提交的符合 QC 标准的更新
2018年3月8日
最后验证
2018年3月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 79213417.0.0000.5402
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Cardiovascular rehabilitation的临床试验
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IRCCS Eugenio Medea招聘中