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

Completed

• Conditions: Cardiovascular Diseases; Cardiovascular Risk Factor

• Registration Number: NCT04790643
• Lead Sponsor: Universidade Estadual Paulista Júlio de Mesquita Filho

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-17
• Study First Submitted QC: 2021-03-05
• Study First Posted: 2021-03-10
• Study Start: 2021-05-03
• Primary Completion: 2022-10-30
• Study Completion: 2023-12-30
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-02
• Last Update Posted: 2024-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Resting heart rate	Baseline assessment	Evaluated through a heart rate monitor during a resting period of 20 minutes. The mean heart rate obtained between the 5th and 20th minutes will be considered.
Maximum inspiratory pressure	Baseline assessment	Evaluated through a manovacuometer. This assessment will be evaluated three times and the value considered will be the mean of all measures.
Peak expiratory flow	Baseline assessment	Evaluated through the spirometric examination performed by an experienced physiotherapist.
Blood pressure	Baseline assessment	Evaluated indirectly by an experienced physiotherapist using a stethoscope and a sphygmomanometer. The blood pressure will be evaluated three times after a resting period of 15 minutes. The mean value of the last 2 measures will be considered.
Forced expiratory volume in the first second	Baseline assessment	Evaluated through the spirometric examination performed by an experienced physiotherapist.
Forced vital capacity	Baseline assessment	Evaluated through the spirometric examination performed by an experienced physiotherapist.
Signs and symptoms	Baseline assessment	The occurrence rate of signs and symptoms will be evaluated during the exercise performed in cardiac rehabilitation programs. The signs and symptoms considered are: arrhythmia, the elevation of systolic and diastolic blood pressure, tachypnea, pallor, angina, cramp, muscle pain, fatigue, and nausea.
Maximum expiratory pressure	Baseline assessment	Evaluated through a manovacuometer. This assessment will be evaluated three times and the value considered will be the mean of all measures.
Cardiac autonomic modulation - RMSSD index	Baseline assessment	The data for this evaluation will be collected using a heart rate monitor that registers the heart rate beat by beat and provides information regarding the RR intervals. To obtain the RR intervals time series, the volunteer will rest for 30 minutes in spontaneous breathing. Will be considered 1000 consecutive RR intervals recorded between the 5th and 30th minutes of rest. The RMSSD index corresponds to the root-mean square of differences between adjacent normal RR intervals in a time interval, expressed in milliseconds.
Cardiac autonomic modulation - SDNN index	Baseline assessment	The data for this evaluation will be collected using a heart rate monitor that registers the heart rate beat by beat and provides information regarding the RR intervals. To obtain the RR intervals time series, the volunteer will rest for 30 minutes in spontaneous breathing. Will be considered 1000 consecutive RR intervals recorded between the 5th and 30th minutes of rest. The SDNN index corresponds to the standard deviation of all normal RR intervals recorded in a time interval, expressed in milliseconds.
Cardiac autonomic modulation - SD1/SD2 ratio	Baseline assessment	This index is obtained by dividing the SD1 value by the SD2 value.
Quadriceps muscle strength	Baseline assessment	Evaluated through a digital dynamometer. The volunteer will perform three maximal isometric contractions of quadriceps with a duration of 5 seconds. The value considered will be the higher one among the three contractions.
Body mass index	Baseline assessment	Calculated using the data of body mass assessed by a digital scale and height evaluated through a stadiometer.
Total water in the lean mass (%)	Baseline assessment	Evaluated through a tetrapolar electrical bioimpedance examination.
Body fat (%)	Baseline assessment	Evaluated through a tetrapolar electrical bioimpedance examination.
Cardiac autonomic modulation - LF index (ms²)	Baseline assessment	The data for this evaluation will be collected using a heart rate monitor that registers the heart rate beat by beat and provides information regarding the RR intervals. To obtain the RR intervals time series, the volunteer will rest for 30 minutes in spontaneous breathing. Will be considered 1000 consecutive RR intervals recorded between the 5th and 30th minutes of rest. The LF index is the low-frequency component of the oscillatory components of heart rate variability, and ranges from 0.04 to 0.15 Hz.
Cardiac autonomic modulation - HF index (ms²)	Baseline assessment	The data for this evaluation will be collected using a heart rate monitor that registers the heart rate beat by beat and provides information regarding the RR intervals. To obtain the RR intervals time series, the volunteer will rest for 30 minutes in spontaneous breathing. Will be considered 1000 consecutive RR intervals recorded between the 5th and 30th minutes of rest. The HF index is the high-frequency component of the oscillatory components of heart rate variability, and ranges from 0.15 to 0.4 Hz.
Cardiac autonomic modulation - LF index (nu)	Baseline assessment	The LF index expressed in normalizefd units (nu) is obtained by dividing the power in milliseconds by the total power spectrum, minus the very low frequency component and multiplied by 100.
Cardiac autonomic modulation - SD1 index	Baseline assessment	The data for this evaluation will be collected using a heart rate monitor that registers the heart rate beat by beat and provides information regarding the RR intervals. To obtain the RR intervals time series, the volunteer will rest for 30 minutes in spontaneous breathing. Will be considered 1000 consecutive RR intervals recorded between the 5th and 30th minutes of rest. The SD1 index corresponds to the dispersion of points perpendicular to the line of identity of the ellipse obtained from the Poincaré plot. Expressed in milliseconds.
Cardiac autonomic modulation - HF index (nu)	Baseline assessment	The HF index expressed in normalizefd units (nu) is obtained by dividing the power in milliseconds by the total power spectrum, minus the very low frequency component and multiplied by 100.
Cardiac autonomic modulation - LF/HF ratio	Baseline assessment	This index is obtained by dividing the LF (ms²) value by the HF (ms²) value.
Cardiac autonomic modulation - SD2 index	Baseline assessment	The data for this evaluation will be collected using a heart rate monitor that registers the heart rate beat by beat and provides information regarding the RR intervals. To obtain the RR intervals time series, the volunteer will rest for 30 minutes in spontaneous breathing. Will be considered 1000 consecutive RR intervals recorded between the 5th and 30th minutes of rest. The SD1 index corresponds to the dispersion of points along the line of identity of the ellipse obtained from the Poincaré plot. Expressed in milliseconds.
Waist circumference	Baseline assessment	Measured with an inelastic measuring tape at the lower abdominal perimeter. Three measurements will be taken and the average of the values obtained will be considered.
Calf circumference	Baseline assessment	Measured with an inelastic measuring tape at the largest circumference in the region of the right calf with the lower limb relaxed without receiving weight. Three measurements will be taken and the average of the values obtained will be considered.
Reactance (Ohms)	Baseline assessment	Evaluated through a tetrapolar electrical bioimpedance examination.
Body fat (Kg)	Baseline assessment	Evaluated through a tetrapolar electrical bioimpedance examination.
Total lean mass (Kg)	Baseline assessment	Evaluated through a tetrapolar electrical bioimpedance examination.
Abdominal circumference	Baseline assessment	Measured with an inelastic measuring tape at the umbilical scar line. Three measurements will be taken and the average of the values obtained will be considered.
Resistance (Ohms)	Baseline assessment	Evaluated through a tetrapolar electrical bioimpedance examination.
Hip circumference	Baseline assessment	Measured with an inelastic measuring tape at the largest perimeter in the gluteal region. Three measurements will be taken and the average of the values obtained will be considered.
Arm circumference	Baseline assessment	Measured with an inelastic measuring tape at the midpoint between the acromion and the olecranon with the upper limb relaxed. Three measurements will be taken and the average of the values obtained will be considered.
Basal metabolic rate (cal/day)	Baseline assessment	Evaluated through a tetrapolar electrical bioimpedance examination.
Total body water (%)	Baseline assessment	Evaluated through a tetrapolar electrical bioimpedance examination.
Submaximal functional capacity	Baseline assessment	Evaluated by the 6-minute walk test. The values considered will be the distance covered and the % of the predicted value reached.

Trial Locations

Locations (1)

Universidade Estadual Paulista Júlio de Mesquita Filho; 🇧🇷 Presidente Prudente, São Paulo, Brazil