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风险分层方案以及临床、体格和生化参数在心血管康复计划中预测信号和症状的有效性:一项观察性试验方案

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.

作者信息

Vanzella Laís Manata, Takahashi Carolina, Ribeiro Felipe, Lima Isabelle Maina, Silva Anne Kastelianne França da, Christófaro Diego Giulliano Destro, Vanderlei Luiz Carlos Marques

机构信息

São Paulo State University (UNESP), School of Sciences and Technology, Presidente Prudente, São Paulo, Brazil.

出版信息

Medicine (Baltimore). 2019 Jun;98(24):e15700. doi: 10.1097/MD.0000000000015700.

Abstract

INTRODUCTION

Despite the benefits, cardiovascular rehabilitation programs (CRPs) have been related to the appearance of signals and symptoms. Risk stratification protocols are commonly used to identify risks during the physical exercise; however, studies that investigate their efficacy to previse signals and symptoms are inconclusive. Furthermore, clinical, physical, and biochemical parameters have been used as risk markers for the appearance of adverse events, and to investigate their efficacy to previse signals and symptoms during the CRP sessions that could better guide the strategies adopted on these programs.

OBJECTIVES

The aim of this study was to evaluate the correlations between risk stratification protocols and clinical, physical, and biochemical parameters with the appearance of signals/symptoms during CRP, as well as to evaluate if modifications on clinical, physical, and biochemical parameters could influence in the appearance of signals/symptoms during CRP.

MATERIALS AND METHODS

The study was prospectively registered at ClinicalTrials.gov (NCT03446742). Forty-four patient participants of a CRP will be evaluated. First, their risk stratification is going to be performed by 2 evaluators and their clinical, physical, and biochemical parameters are going to be measured. Then, the patients are going to be followed during 24 sessions during their CRP routines in order to identify appearance of their signals/symptoms. So, the patients are going to perform their cardiovascular rehabilitation routines for 6 months and then, their clinical, physical, and biochemical parameters are going to be measured again and they are going to be followed during 24 sessions during their CRP routines in order to identify the appearance of their signals/symptoms.

摘要

引言

尽管心血管康复计划(CRP)有诸多益处,但它与一些体征和症状的出现有关。风险分层方案通常用于识别体育锻炼期间的风险;然而,研究其预测体征和症状有效性的研究尚无定论。此外,临床、身体和生化参数已被用作不良事件出现的风险标志物,并用于研究它们在CRP疗程中预测体征和症状的有效性,这可能会更好地指导这些计划所采用的策略。

目的

本研究的目的是评估风险分层方案以及临床、身体和生化参数与CRP期间体征/症状出现之间的相关性,并评估临床、身体和生化参数的变化是否会影响CRP期间体征/症状的出现。

材料与方法

该研究已在ClinicalTrials.gov(NCT03446742)上进行前瞻性注册。将对44名参与CRP的患者进行评估。首先,由2名评估人员对他们进行风险分层,并测量他们的临床、身体和生化参数。然后,在患者进行CRP常规治疗的24个疗程中对他们进行随访,以确定他们体征/症状的出现情况。因此,患者将进行6个月的心血管康复常规治疗,然后再次测量他们的临床、身体和生化参数,并在他们CRP常规治疗的24个疗程中对他们进行随访,以确定他们体征/症状的出现情况。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/64dd/6587603/44eac9471b6b/medi-98-e15700-g001.jpg

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