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Elaboration and Analysis of a New Cardiac Risk Stratification Protocol Based on Clinical and Physical Variables

Cardiovascular Diseases Clinical Trial

Official title:
Elaboration and Analysis of a New Cardiac Risk Stratification Protocol Based on Clinical and Physical Variables to Predict the Occurrence of Signs and Symptoms During a Cardiac Rehabilitation Program

Clinical Trial Summary

This research project has as objective the elaboration and analysis of a new cardiac risk stratification protocol based on clinical and physical variables to predict the occurrence of signs and symptoms during a cardiac rehabilitation program. To this aim, the study will be developed in three stages. The first stage consists of a prospective longitudinal observational study, in which participants of exercise-based cardiac rehabilitation will undergo a physiotherapy evaluation in terms of physical and clinical aspects. After this initial assessment, participants will be followed for 2 months of rehabilitation, when the occurrence of signs and symptoms (chest pain, fatigue, dizziness, arrhythmias, and other minor events) during exercise will be recorded. Based on the data from the initial assessment and the occurrence of signs and symptoms a new cardiac risk stratification protocol will be developed. The second stage of this project consists of another prospective longitudinal observational study in which a new sample of individuals attending cardiac rehabilitation programs will be assessed and stratified for the risk of the occurrence of signs and symptoms during exercise by the new protocol developed. After the risk stratification, this sample will be followed for 2 months and the occurrence of signs and symptoms will be recorded. With this data, the reproducibility and efficacy of the protocol will be evaluated. The third stage of this project consists of a cross-sectional observational study, in which a new sample of participants will be evaluated by two independent physiotherapists for clinical and physical variables, and based on these data will be stratified by the new protocol by the same evaluators independently. After these procedures, the protocol´s agreement between evaluators will be analyzed.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04790643
Study type Observational
Source Universidade Estadual Paulista Júlio de Mesquita Filho
Contact Luiz Carlos Marques Vanderlei, PhD
Phone +55183229-5819
Email lcm.vanderlei@unesp.br
Status Recruiting
Phase
Start date May 3, 2021
Completion date August 2022
View Details
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