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Completed

NCT Number: NCT03986879

Relationship of the Physical Activity Practice and Its Different Domains With 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.

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Key information

Conditions

Adult Disease Behavior Disease Motor Activity Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Diego Giulliano Destro Christofaro

Presidente Prudente, São Paulo, 19060-900, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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%

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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)

  7. 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.

  8. 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.

  9. 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).

Sponsors and collaborators

Lead sponsor

Bruna Thamyres Ciccotti Saraiva

Other

Collaborators

  • Fundação de Amparo à Pesquisa do Estado de São Paulo

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jun 14, 2019
Registry last updated
Mar 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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