Cardiovascular DiseasesNCT04790643
Elaboration and Analysis of a New Cardiac Risk Stratification Protocol Based on Clinical and Physical Variables
An observational study of Cardiovascular Diseases and Cardiovascular Risk Factor, run by Universidade Estadual Paulista Júlio de Mesquita Filho at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Diseases, Cardiovascular Risk Factor
- What is being tested?
- Exercise-based cardiac rehabilitation program (Stage 1) and Exercise-based cardiac rehabilitation program (Stage 2)
- Type of treatment
- Injection or infusion
- How many people
- 120 participants
- Where
- 1 siteBrazil
- Study dates
- 3 May 2021to 30 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The population will be recruited from cardiac rehabilitation centers located in Presidente Prudente - SP, Brazil.
Who may be able to join
- Main medical diagnostic of any cardiovascular disease and/or presence of cardiovascular risk factors
- Be participating in exercise-based cardiac rehabilitation
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Universidade Estadual Paulista Júlio de Mesquita Filho
Presidente Prudente, São Paulo, 19060900
About this study
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
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.
- Being tested
- Exercise-based cardiac rehabilitation program (Stage 1), Exercise-based cardiac rehabilitation program (Stage 2)
- Keywords
- Cardiac Rehabilitation, Cardiac Risk Stratification, Exercise, Cardiovascular Diseases
- Medical subject headings
- Cardiovascular Diseases, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise-based cardiac rehabilitation program (Stage 1)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).
Exercise-based cardiac rehabilitation program (Stage 2)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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Exercise-based cardiac rehabilitation program (Stage 1) | |
| 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. Receives: Other: Exercise-based cardiac rehabilitation program (Stage 2) | |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline assessment
Peak expiratory flow
Evaluated through the spirometric examination performed by an experienced physiotherapist.
Measured: Baseline assessment
Forced expiratory volume in the first second
Evaluated through the spirometric examination performed by an experienced physiotherapist.
Measured: Baseline assessment
Forced vital capacity
Evaluated through the spirometric examination performed by an experienced physiotherapist.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline assessment
Cardiac autonomic modulation - LF/HF ratio
This index is obtained by dividing the LF (ms²) value by the HF (ms²) value.
Measured: 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.
Measured: 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.
Measured: Baseline assessment
Cardiac autonomic modulation - SD1/SD2 ratio
This index is obtained by dividing the SD1 value by the SD2 value.
Measured: 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.
Measured: 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.
Measured: Baseline assessment
Body mass index
Calculated using the data of body mass assessed by a digital scale and height evaluated through a stadiometer.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline assessment
Basal metabolic rate (cal/day)
Evaluated through a tetrapolar electrical bioimpedance examination.
Measured: Baseline assessment
Total body water (%)
Evaluated through a tetrapolar electrical bioimpedance examination.
Measured: Baseline assessment
Total water in the lean mass (%)
Evaluated through a tetrapolar electrical bioimpedance examination.
Measured: Baseline assessment
Resistance (Ohms)
Evaluated through a tetrapolar electrical bioimpedance examination.
Measured: Baseline assessment
Reactance (Ohms)
Evaluated through a tetrapolar electrical bioimpedance examination.
Measured: Baseline assessment
Body fat (%)
Evaluated through a tetrapolar electrical bioimpedance examination.
Measured: Baseline assessment
Body fat (Kg)
Evaluated through a tetrapolar electrical bioimpedance examination.
Measured: Baseline assessment
Total lean mass (Kg)
Evaluated through a tetrapolar electrical bioimpedance examination.
Measured: Baseline assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2021
- Study start3 May 2021
- Primary completion30 Oct 2022
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Estadual Paulista Júlio de Mesquita Filho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luiz Carlos Marques Vanderlei, Universidade Estadual Paulista Júlio de Mesquita Filho
- Investigators
- Luiz Carlos Marques Vanderlei, PhD, Principal investigator, Universidade Estadual Paulista "Julho de Mesquita Filho" (UNESP)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04790643
- Sponsor's protocol ID
- 35831220.8.0000.5402
- Status last verified
- Jul 2024
- First submitted
- 17 Feb 2021
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04790643
- Acronym / sponsor ID
- 35831220.8.0000.5402
- Keywords
- Cardiac Rehabilitation, Cardiac Risk Stratification, Exercise, Cardiovascular Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Universidade Estadual Paulista Júlio de Mesquita FilhoUniversity, hospital or other
- Study start
- 3 May 2021 (actual)
- Primary completion
- 30 Oct 2022 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 10 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Stage 1 - Development of the new cardiac risk stratification protocol | – | Other: Exercise-based cardiac rehabilitation program (Stage 1)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. |
| Stage 2 - Reproducibility and efficiency of the new protocol | – | Other: Exercise-based cardiac rehabilitation program (Stage 2)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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population will be recruited from cardiac rehabilitation centers located in Presidente Prudente - SP, Brazil.
Key inclusion criteria (2 listed)
- Main medical diagnostic of any cardiovascular disease and/or presence of cardiovascular risk factors
- Be participating in exercise-based cardiac rehabilitation
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Other | Stage 1 - Development of the new cardiac risk stratification protocol |
| 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. | Other | Stage 2 - Reproducibility and efficiency of the new protocol |
Primary outcome
Signs and symptoms
Time frame: 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.
Resting heart rate
Time frame: 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.
Blood pressure
Time frame: 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.
Maximum inspiratory pressure
Time frame: Baseline assessment
Evaluated through a manovacuometer. This assessment will be evaluated three times and the value considered will be the mean of all measures.
Maximum expiratory pressure
Time frame: 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
Time frame: Baseline assessment
Evaluated through the spirometric examination performed by an experienced physiotherapist.
Forced expiratory volume in the first second
Time frame: Baseline assessment
Evaluated through the spirometric examination performed by an experienced physiotherapist.
Forced vital capacity
Time frame: Baseline assessment
Evaluated through the spirometric examination performed by an experienced physiotherapist.
Cardiac autonomic modulation - RMSSD index
Time frame: 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
Time frame: 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 - LF index (ms²)
Time frame: 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)
Time frame: 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)
Time frame: 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 - HF index (nu)
Time frame: 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
Time frame: Baseline assessment
This index is obtained by dividing the LF (ms²) value by the HF (ms²) value.
Cardiac autonomic modulation - SD1 index
Time frame: 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 - SD2 index
Time frame: 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.
Cardiac autonomic modulation - SD1/SD2 ratio
Time frame: Baseline assessment
This index is obtained by dividing the SD1 value by the SD2 value.
Quadriceps muscle strength
Time frame: 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.
Submaximal functional capacity
Time frame: Baseline assessment
Evaluated by the 6-minute walk test. The values considered will be the distance covered and the % of the predicted value reached.
Body mass index
Time frame: Baseline assessment
Calculated using the data of body mass assessed by a digital scale and height evaluated through a stadiometer.
Waist circumference
Time frame: 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.
Abdominal circumference
Time frame: 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.
Hip circumference
Time frame: 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
Time frame: 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.
Calf circumference
Time frame: 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.
Basal metabolic rate (cal/day)
Time frame: Baseline assessment
Evaluated through a tetrapolar electrical bioimpedance examination.
Total body water (%)
Time frame: Baseline assessment
Evaluated through a tetrapolar electrical bioimpedance examination.
Total water in the lean mass (%)
Time frame: Baseline assessment
Evaluated through a tetrapolar electrical bioimpedance examination.
Resistance (Ohms)
Time frame: Baseline assessment
Evaluated through a tetrapolar electrical bioimpedance examination.
Reactance (Ohms)
Time frame: Baseline assessment
Evaluated through a tetrapolar electrical bioimpedance examination.
Body fat (%)
Time frame: Baseline assessment
Evaluated through a tetrapolar electrical bioimpedance examination.
Body fat (Kg)
Time frame: Baseline assessment
Evaluated through a tetrapolar electrical bioimpedance examination.
Total lean mass (Kg)
Time frame: Baseline assessment
Evaluated through a tetrapolar electrical bioimpedance examination.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luiz Carlos Marques Vanderlei, PhD principal investigator
Universidade Estadual Paulista "Julho de Mesquita Filho" (UNESP)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Cardiovascular Risk Factor, run by Universidade Estadual Paulista Júlio de Mesquita Filho at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Signs and symptoms (time frame: Baseline assessment). The study lists 34 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2024.