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

NCT ID: NCT04790643

Last Updated: 2024-07-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-05-03
• Study Completion Date: 2023-12-30

Brief 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

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: OTHER

Study Groups

Stage 1 - Development of the new cardiac risk stratification protocol

This will be a prospective cohort study, in which individuals attending cardiac rehabilitation programs will be assessed by clinical and physical variables that will be used to guide the elaboration of the cardiac risk stratification protocol. After this initial evaluation, the volunteers will be followed for 2 months during their habitual cardiac rehabilitation routine for the evaluation and registry of the occurrence of minor adverse events, defined as signs and symptoms (arrhythmias, blood pressure alterations, tachypnea, pallor, chest pain, cramps, muscle pain, fatigue, and nausea). The cardiac rehabilitation program in which the volunteers will be recruited is based on moderate-intensity aerobic exercise.

Exercise-based cardiac rehabilitation program (Stage 1)

Intervention Type: OTHER

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).

Stage 2 - Reproducibility and efficiency of the new protocol

This will be a prospective cohort study, in which a new sample of individuals attending cardiac rehabilitation programs will be assessed by clinical and physical variables and stratified in one of the three following risk classes: "low risk", "moderate risk", and "high risk" accordingly to the new risk stratification protocol. After that, the sample will be followed for 2 months of rehabilitation to the evaluation of the occurrence of signs and symptoms. The cardiac rehabilitation program from where the volunteers will be recruited is based on moderate-intensity aerobic exercise and resistance training. With these data, the reproducibility and efficiency of the protocol will be evaluated.

Exercise-based cardiac rehabilitation program (Stage 2)

Intervention Type: OTHER

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.

Stage 3 - Protocols´ agreement between evaluators

This will be 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.

No interventions assigned to this group

Interventions

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).

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Main medical diagnostic of any cardiovascular disease and/or presence of cardiovascular risk factors
• Be participating in exercise-based cardiac rehabilitation

Exclusion Criteria

• Orthopedic and/or neurologic conditions that preclude the realization of any of the physical and clinical evaluations
• Do not complete 24 cardiac rehabilitation sessions during the follow-up period

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidade Estadual Paulista Júlio de Mesquita Filho

OTHER

Sponsor Role: lead

Responsible Party

Luiz Carlos Marques Vanderlei

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Luiz Carlos Marques Vanderlei, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidade Estadual Paulista "Julho de Mesquita Filho" (UNESP)

Locations

Universidade Estadual Paulista Júlio de Mesquita Filho

Presidente Prudente, São Paulo, Brazil

Countries

Brazil

Other Identifiers

35831220.8.0000.5402

Identifier Type: -

Identifier Source: org_study_id