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 Details — Status: Recruiting

Administrative data

• NCT number: NCT04790643
• Other study ID #: 35831220.8.0000.5402
• Status: Recruiting
• Start date: May 3, 2021
• Est. completion date: August 2022

Study information

• Verified date: July 2021
• Source: Universidade Estadual Paulista Júlio de Mesquita Filho
• Contact: Luiz Carlos Marques Vanderlei, PhD
• Phone: +55183229-5819
• Email: lcm.vanderlei[@]unesp.br
• Is FDA regulated: No
• Study type: Observational

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: August 2022
• Est. primary completion date: April 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Cardiovascular Risk Factor

Intervention

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).
• 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.

Locations

Country	Name	City	State
Brazil	Universidade Estadual Paulista Júlio de Mesquita Filho	Presidente Prudente	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Estadual Paulista Júlio de Mesquita Filho

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Reproducibility of the risk stratification protocol to predict the signs and symptoms occurrence	The agreement between the risk class and the number of signs and symptoms that occurred will be calculated using the Kappa intraclass correlation coefficient.	Through study completion, an average of 2 years
Other	Efficacy of the risk stratification protocol to predict the signs and symptoms occurrence	The effectiveness of the protocol in predicting the occurrence of signs and symptoms will be assessed by analyzing the ROC curve, by measuring sensitivity, specificity and area under the curve (AUC).	Through study completion, an average of 2 years
Other	Agreement between evaluators	Reliability between evaluators will be assessed using the percentage of agreement and disagreement and the Kappa index.	Through study completion, an average of 2 years
Primary	Signs and symptoms	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.	Baseline assessment
Primary	Resting heart rate	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.	Baseline assessment
Primary	Blood pressure	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.	Baseline assessment
Primary	Maximum inspiratory pressure	Evaluated through a manovacuometer. This assessment will be evaluated three times and the value considered will be the mean of all measures.	Baseline assessment
Primary	Maximum expiratory pressure	Evaluated through a manovacuometer. This assessment will be evaluated three times and the value considered will be the mean of all measures.	Baseline assessment
Primary	Peak expiratory flow	Evaluated through the spirometric examination performed by an experienced physiotherapist.	Baseline assessment
Primary	Forced expiratory volume in the first second	Evaluated through the spirometric examination performed by an experienced physiotherapist.	Baseline assessment
Primary	Forced vital capacity	Evaluated through the spirometric examination performed by an experienced physiotherapist.	Baseline assessment
Primary	Cardiac autonomic modulation - RMSSD index	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.	Baseline assessment
Primary	Cardiac autonomic modulation - SDNN index	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.	Baseline assessment
Primary	Cardiac autonomic modulation - LF index (ms²)	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.	Baseline assessment
Primary	Cardiac autonomic modulation - HF index (ms²)	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.	Baseline assessment
Primary	Cardiac autonomic modulation - LF index (nu)	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.	Baseline assessment
Primary	Cardiac autonomic modulation - HF index (nu)	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.	Baseline assessment
Primary	Cardiac autonomic modulation - LF/HF ratio	This index is obtained by dividing the LF (ms²) value by the HF (ms²) value.	Baseline assessment
Primary	Cardiac autonomic modulation - SD1 index	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.	Baseline assessment
Primary	Cardiac autonomic modulation - SD2 index	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.	Baseline assessment
Primary	Cardiac autonomic modulation - SD1/SD2 ratio	This index is obtained by dividing the SD1 value by the SD2 value.	Baseline assessment
Primary	Quadriceps muscle strength	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.	Baseline assessment
Primary	Submaximal functional capacity	Evaluated by the 6-minute walk test. The values considered will be the distance covered and the % of the predicted value reached.	Baseline assessment
Primary	Body mass index	Calculated using the data of body mass assessed by a digital scale and height evaluated through a stadiometer.	Baseline assessment
Primary	Waist circumference	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.	Baseline assessment
Primary	Abdominal circumference	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.	Baseline assessment
Primary	Hip circumference	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.	Baseline assessment
Primary	Arm circumference	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.	Baseline assessment
Primary	Calf circumference	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.	Baseline assessment
Primary	Basal metabolic rate (cal/day)	Evaluated through a tetrapolar electrical bioimpedance examination.	Baseline assessment
Primary	Total body water (%)	Evaluated through a tetrapolar electrical bioimpedance examination.	Baseline assessment
Primary	Total water in the lean mass (%)	Evaluated through a tetrapolar electrical bioimpedance examination.	Baseline assessment
Primary	Resistance (Ohms)	Evaluated through a tetrapolar electrical bioimpedance examination.	Baseline assessment
Primary	Reactance (Ohms)	Evaluated through a tetrapolar electrical bioimpedance examination.	Baseline assessment
Primary	Body fat (%)	Evaluated through a tetrapolar electrical bioimpedance examination.	Baseline assessment
Primary	Body fat (Kg)	Evaluated through a tetrapolar electrical bioimpedance examination.	Baseline assessment
Primary	Total lean mass (Kg)	Evaluated through a tetrapolar electrical bioimpedance examination.	Baseline assessment