Clinical trial NCT04790643: Elaboration and Analysis of a New Cardiac Risk Stratification Protocol Based on Clinical and Physical Variables
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Cardiovascular Risk Factor
Keywords: Cardiac Rehabilitation
Cardiac Risk Stratification
Exercise
Cardiovascular Diseases
Lead sponsor: Universidade Estadual Paulista Júlio de Mesquita Filho
Sponsor class: OTHER
First posted: 2021-03-10
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population will be recruited from cardiac rehabilitation centers located in Presidente Prudente - SP, Brazil.

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.


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

Primary outcomes:
measure: Signs and symptoms
timeFrame: Baseline assessment
measure: Resting heart rate
timeFrame: Baseline assessment
measure: Blood pressure
timeFrame: Baseline assessment
measure: Maximum inspiratory pressure
timeFrame: Baseline assessment
measure: Maximum expiratory pressure
timeFrame: Baseline assessment
measure: Peak expiratory flow
timeFrame: Baseline assessment
measure: Forced expiratory volume in the first second
timeFrame: Baseline assessment
measure: Forced vital capacity
timeFrame: Baseline assessment
measure: Cardiac autonomic modulation - RMSSD index
timeFrame: Baseline assessment
measure: Cardiac autonomic modulation - SDNN index
timeFrame: Baseline assessment
measure: Cardiac autonomic modulation - LF index (ms²)
timeFrame: Baseline assessment
measure: Cardiac autonomic modulation - HF index (ms²)
timeFrame: Baseline assessment
measure: Cardiac autonomic modulation - LF index (nu)
timeFrame: Baseline assessment
measure: Cardiac autonomic modulation - HF index (nu)
timeFrame: Baseline assessment
measure: Cardiac autonomic modulation - LF/HF ratio
timeFrame: Baseline assessment
measure: Cardiac autonomic modulation - SD1 index
timeFrame: Baseline assessment
measure: Cardiac autonomic modulation - SD2 index
timeFrame: Baseline assessment
measure: Cardiac autonomic modulation - SD1/SD2 ratio
timeFrame: Baseline assessment
measure: Quadriceps muscle strength
timeFrame: Baseline assessment
measure: Submaximal functional capacity
timeFrame: Baseline assessment
measure: Body mass index
timeFrame: Baseline assessment
measure: Waist circumference
timeFrame: Baseline assessment
measure: Abdominal circumference
timeFrame: Baseline assessment
measure: Hip circumference
timeFrame: Baseline assessment
measure: Arm circumference
timeFrame: Baseline assessment
measure: Calf circumference
timeFrame: Baseline assessment
measure: Basal metabolic rate (cal/day)
timeFrame: Baseline assessment
measure: Total body water (%)
timeFrame: Baseline assessment
measure: Total water in the lean mass (%)
timeFrame: Baseline assessment
measure: Resistance (Ohms)
timeFrame: Baseline assessment
measure: Reactance (Ohms)
timeFrame: Baseline assessment
measure: Body fat (%)
timeFrame: Baseline assessment
measure: Body fat (Kg)
timeFrame: Baseline assessment
measure: Total lean mass (Kg)
timeFrame: Baseline assessment
Secondary outcomes:
Other outcomes:
measure: Reproducibility of the risk stratification protocol to predict the signs and symptoms occurrence
timeFrame: Through study completion, an average of 2 years
measure: Efficacy of the risk stratification protocol to predict the signs and symptoms occurrence
timeFrame: Through study completion, an average of 2 years
measure: Agreement between evaluators
timeFrame: Through study completion, an average of 2 years
Locations:
city: Presidente Prudente
country: Brazil
facility: Universidade Estadual Paulista Júlio de Mesquita Filho
state: São Paulo
Study officials:
affiliation: Universidade Estadual Paulista "Julho de Mesquita Filho" (UNESP)
name: Luiz Carlos Marques Vanderlei, PhD
role: PRINCIPAL_INVESTIGATOR
References: