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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Cardiovascular Diseases, Cardiovascular Risk Factor

Intervention / Treatment
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* Other: Exercise-based cardiac rehabilitation program (Stage 1)
* Other: Exercise-based cardiac rehabilitation program (Stage 2)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Stage 1 - Development of the new cardiac risk stratification protocol<br>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. | Other: Exercise-based cardiac rehabilitation program (Stage 1)<br>* 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).<br>|
| Stage 2 - Reproducibility and efficiency of the new protocol<br>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. | Other: Exercise-based cardiac rehabilitation program (Stage 2)<br>* 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.<br>|
| Stage 3 - Protocols´ agreement between evaluators<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| Peak expiratory flow | Evaluated through the spirometric examination performed by an experienced physiotherapist. | Baseline assessment | 
| Forced expiratory volume in the first second | Evaluated through the spirometric examination performed by an experienced physiotherapist. | Baseline assessment | 
| Forced vital capacity | Evaluated through the spirometric examination performed by an experienced physiotherapist. | Baseline assessment | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| Cardiac autonomic modulation - LF/HF ratio | This index is obtained by dividing the LF (ms²) value by the HF (ms²) value. | Baseline assessment | 
| 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 | 
| 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 | 
| Cardiac autonomic modulation - SD1/SD2 ratio | This index is obtained by dividing the SD1 value by the SD2 value. | Baseline assessment | 
| 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 | 
| 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 | 
| Body mass index | Calculated using the data of body mass assessed by a digital scale and height evaluated through a stadiometer. | Baseline assessment | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| Basal metabolic rate (cal/day) | Evaluated through a tetrapolar electrical bioimpedance examination. | Baseline assessment | 
| Total body water (%) | Evaluated through a tetrapolar electrical bioimpedance examination. | Baseline assessment | 
| Total water in the lean mass (%) | Evaluated through a tetrapolar electrical bioimpedance examination. | Baseline assessment | 
| Resistance (Ohms) | Evaluated through a tetrapolar electrical bioimpedance examination. | Baseline assessment | 
| Reactance (Ohms) | Evaluated through a tetrapolar electrical bioimpedance examination. | Baseline assessment | 
| Body fat (%) | Evaluated through a tetrapolar electrical bioimpedance examination. | Baseline assessment | 
| Body fat (Kg) | Evaluated through a tetrapolar electrical bioimpedance examination. | Baseline assessment | 
| Total lean mass (Kg) | Evaluated through a tetrapolar electrical bioimpedance examination. | Baseline assessment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiac Rehabilitation, Cardiac Risk Stratification, Exercise, Cardiovascular Diseases