Relationship of the Physical Activity Practice and Its Different Domains With Cardiac Autonomic Modulation

March 25, 2025 updated by: Bruna Thamyres Ciccotti Saraiva

Relationship of the Intensity of Physical Activity Practice and Its Different Domains With Cardiac Autonomic Modulation in Adult Individuals

Overall objective: To analyze the relationship of the physical activity practice measured directly with the autonomic cardiac modulation in adults. Specific objectives: i) to verify through the Baecke questionnaire whether the different domains of physical activity (work, leisure and occupational activities) are related in the same way to the autonomic cardiac modulation; ii) Analyze whether high blood pressure and resting heart rate values are related to poor cardiac autonomic modulation regardless of nutritional status.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

Cardiovascular disease is a major public health problem and has contributed to a high mortality rate in the adult population. One of the precursors of these diseases is low cardiac autonomic modulation. Thus, factors that may be related to greater cardiac autonomic modulation should be investigated with the aim of preventing cardiovascular diseases. One of these factors that may contribute to increases in cardiac autonomic modulation is the practice of physical activity. However, the studies investigating this relationship have been controversial, generally evaluating the practice of physical activity in a subjective way, and there is no clarity as to whether the different domains of physical activity would be related differently to cardiac autonomic modulation. Overall objective: To analyze the relationship of the physical activity practice measured directly with the autonomic cardiac modulation in adults. Specific objectives: i) to verify through the Baecke questionnaire whether the different domains of physical activity (work, leisure and occupational activities) are related in the same way to the autonomic cardiac modulation; ii) Analyze whether high blood pressure and resting heart rate values are related to poor cardiac autonomic modulation regardless of nutritional status. Implications: The results of this study will contribute to clarify the relationship between physical activity practice and cardiac autonomic modulation considering a large sample of subjects (n = 252), as well as whether the different domains of physical activity are related to autonomic modulation cardiac. These results may help in the elaboration of health promotion strategies.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
252

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Sao Paulo
      • Presidente Prudente, Sao Paulo, Brazil, 19060-900
        • Diego Giulliano Destro Christofaro

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

The sample will be composed of adults aged 18 years or older from the city of Santo Anastácio-SP located in the southeastern region of Brazil.

Description

Inclusion Criteria:

  • 18 years or older
  • be resident of the city of Anastácio-SP (Brazil)
  • sign the informed consent form

Exclusion Criteria:

  • use less than 5 valid accelerometer days
  • present an error in heart rate variability greater than 5%

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Cardiac autonomic modulation
Time Frame: through study completion, an average of 1 year
The heart rate variability will be collected by means of the POLAR V800.
through study completion, an average of 1 year
Physical activity level - objective measure
Time Frame: through study completion, an average of 1 year
Will be collected 7 days of accelerometry by ActiGraph's triaxial accelerometer wGT3X-BT giving the measure in counts per minute.
through study completion, an average of 1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Self-reported physical activity level questionnaire
Time Frame: through study completion, an average of 1 year
Physical activity in different domains will be evaluated by the Baecke et al. (1982). This instrument evaluates the practice of physical activity through 16 questions in the last twelve months, considering the physical effort at work, the practice of sports activities or systematized exercises in leisure and leisure activities. At the end, this instrument offers a dimensionless score for each of the domains and the sum of the score of the three domains also determines the total amount of physical activity practiced by each of the evaluated individuals.
through study completion, an average of 1 year
Systolic Blood pressure
Time Frame: through study completion, an average of 1 year
The systolic blood pressure will be measured by means of the omron digital oscillometric device.
through study completion, an average of 1 year
Diastolic Blood pressure
Time Frame: through study completion, an average of 1 year
The diastolic blood pressure will be measured by means of the omron digital oscillometric device.
through study completion, an average of 1 year
Self-reported practice of physical activity in childhood and adolescence
Time Frame: through study completion, an average of 1 year
To evaluate the practice of physical activity in childhood (age 7 to 10 years) and adolescence (11-17 years) two questions will be asked: if they practiced some kind of sport in these phases of life with supervision of a teacher, with two alternatives of answer: yes or no.
through study completion, an average of 1 year
Resting Heart Rate
Time Frame: through study completion, an average of 1 year
The resting heart rate will be measured by means of the omron digital oscillometric device.
through study completion, an average of 1 year
Body Mass
Time Frame: through study completion, an average of 1 year
Individuals will be evaluated barefoot wearing light clothing. Body mass will be measured by means of a digital scale (Plenna, Brazil)
through study completion, an average of 1 year
Height
Time Frame: through study completion, an average of 1 year
Individuals will be evaluated barefoot wearing light clothing. The height will be evaluated by a fixed stadiometer on the wall.
through study completion, an average of 1 year
Body Mass Index
Time Frame: through study completion, an average of 1 year
The body mass index (BMI) will be calculated by dividing the body mass by the square of the height. Individuals classified up to 24.99 kg/m² will be considered as normal weight, those classified as having a BMI varying from 25.00 kg/m² up to 29.99 kg/m² will be classified as overweight and those with BMI ≥ 30 kg/m² as obese.
through study completion, an average of 1 year
Waist Circumference
Time Frame: through study completion, an average of 1 year
The waist circumference will be evaluated by an inextensible tape (Sanny, Brazil) and will consider the smallest circumference between the last rib and the iliac crest. Abdominal obesity will be considered in men with waist circumference ≥102 cm and women at 88 cm, following the recommendations of the World Health Organization (WHO, 1997).
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bruna Thamyres Ciccotti Saraiva

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Fundação de Amparo à Pesquisa do Estado de São Paulo

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Diego GD Christofaro, PhD, Universidade Estadual Paulista - UNESP

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 10, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 10, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 10, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 30, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 11, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 14, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 26, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 25, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 72191717.9.0000.5402

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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