NCT04790643

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 120 (actual)
• Sponsor: Universidade Estadual Paulista Júlio de Mesquita Filho · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cardiovascular Diseases
• Cardiovascular Risk Factor

Interventions

Type	Name	Description
OTHER	Exercise-based cardiac rehabilitation program (Stage 1)	In Stage 1 the volunteers will perform 24 sessions of exercise-based cardiac rehabilitation. The rehabilitation session is composed of the following activities: I. Initial rest (where the vital signs are evaluated); II. Warming-up (composed of 15 minutes of stretching and global exercises); III. Aerobic exercise (composed of 30 minutes of treadmill or cycle ergometer exercise, the intensity established varies from 40 to 70% of the heart rate reserve for those diagnosed with cardiovascular diseases and from 60 to 80% of the heart rate reserve for those with only cardiac risk factors); IV. Cooldown (composed of 5 minutes of slow walking).
OTHER	Exercise-based cardiac rehabilitation program (Stage 2)	In Stage 2, the volunteers will perform 24 sessions of exercise-based cardiac rehabilitation. The rehabilitation session is composed of the following activities: I. Initial rest; II. Warming-up; III. Aerobic exercise (these three activities are the same as stage 1); IV. Resistance training (composed of 15 minutes of individualized resistance exercises); V. Cooldown.

Timeline

• Start date: 2021-05-03
• Primary completion: 2022-10-30
• Completion: 2023-12-30
• First posted: 2021-03-10
• Last updated: 2024-07-03

Locations

1 site across 1 country: Brazil