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Adult DiseaseNCT03986879

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

An observational study of Adult Disease, run by Bruna Thamyres Ciccotti Saraiva at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Adult Disease
How many people
252 participants
Where
1 siteBrazil
Study dates
10 Nov 2018to 10 Dec 2020
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
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Diego Giulliano Destro Christofaro

    Presidente Prudente, São Paulo, 19060-900

Other trials in Brazil

About this study

Official title: 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.

Read the 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.

Conditions
Adult Disease
Keywords
Physical Activity, Cardiovascular Health, Epidemiological
Medical subject headings
Disease, Motor Activity

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cardiac autonomic modulation

    The heart rate variability will be collected by means of the POLAR V800.

    Measured: through study completion, an average of 1 year

  2. Physical activity level - objective measure

    Will be collected 7 days of accelerometry by ActiGraph's triaxial accelerometer wGT3X-BT giving the measure in counts per minute.

    Measured: through study completion, an average of 1 year

Secondary outcomes (9)

  1. Self-reported physical activity level questionnaire

    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.

    Measured: through study completion, an average of 1 year

  2. Systolic Blood pressure

    The systolic blood pressure will be measured by means of the omron digital oscillometric device.

    Measured: through study completion, an average of 1 year

  3. Diastolic Blood pressure

    The diastolic blood pressure will be measured by means of the omron digital oscillometric device.

    Measured: through study completion, an average of 1 year

  4. Self-reported practice of physical activity in childhood and adolescence

    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.

    Measured: through study completion, an average of 1 year

  5. Resting Heart Rate

    The resting heart rate will be measured by means of the omron digital oscillometric device.

    Measured: through study completion, an average of 1 year

  6. Body Mass

    Individuals will be evaluated barefoot wearing light clothing. Body mass will be measured by means of a digital scale (Plenna, Brazil)

    Measured: through study completion, an average of 1 year

  7. Height

    Individuals will be evaluated barefoot wearing light clothing. The height will be evaluated by a fixed stadiometer on the wall.

    Measured: through study completion, an average of 1 year

  8. Body Mass Index

    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.

    Measured: through study completion, an average of 1 year

  9. Waist Circumference

    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).

    Measured: through study completion, an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jun 2019
  2. Study start10 Nov 2018
  3. Primary completion10 Dec 2020
  4. Study completion10 Dec 2020

Resources

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
Cross-sectional
Enrolment
252 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03986879
Sponsor's protocol ID
72191717.9.0000.5402
Status last verified
Mar 2025
First submitted
30 May 2019
Last updated
26 Mar 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Tebar WR, Borges LO, Delfino LD, Mota J, Ritti-Dias RM, Christofaro DGD. Association of Early Sports Participation With Sedentary Behavior in Community-Dwelling Adults-The Role of Sociodemographic Factors in a Retrospective Epidemiological Study. J Phys Act Health. 2023 Apr 8;20(5):374-384. doi: 10.1123/jpah.2022-0540. Print 2023 May 1.

    PubMed 37030666

  • Tebar WR, Ritti-Dias RM, Mota J, Saraiva BTC, Damato TM, Delfino LD, Farah BQ, Vanderlei LCM, Christofaro DGD. Relationship of Cardiac Autonomic Modulation with Cardiovascular Parameters in Adults, According to Body Mass Index and Physical Activity. J Cardiovasc Transl Res. 2021 Oct;14(5):975-983. doi: 10.1007/s12265-021-10101-3. Epub 2021 Jan 22.

    PubMed 33483920

  • Tebar WR, Ritti-Dias RM, Saraiva BTC, Gil FCS, Delfino LD, Damato TMM, Aguilar BAS, Silva SCB, Mota J, Vanderlei LCM, Christofaro DGD. The relationship between physical activity intensity and domains with cardiac autonomic modulation in adults: An observational protocol study. Medicine (Baltimore). 2019 Oct;98(41):e17400. doi: 10.1097/MD.0000000000017400.

    PubMed 31593091

Questions about this trial

What is this clinical trial studying?

An observational study of Adult Disease, run by Bruna Thamyres Ciccotti Saraiva 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 3 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 26 Mar 2025. 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?

Cardiac autonomic modulation (time frame: through study completion, an average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03986879, which also lists 3 linked publications.

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 26 Mar 2025.

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