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

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ClinicalTrials.gov Identifier: NCT03986879
Recruitment Status : Recruiting
First Posted : June 14, 2019
Last Update Posted : July 18, 2019
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Bruna Thamyres Ciccotti Saraiva, Universidade Estadual Paulista Júlio de Mesquita Filho

Brief 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 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.

Condition or disease
Adult Disease

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.

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Study Type : Observational
Estimated Enrollment : 252 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Relationship of the Intensity of Physical Activity Practice and Its Different Domains With Cardiac Autonomic Modulation in Adult Individuals
Actual Study Start Date : November 10, 2018
Estimated Primary Completion Date : December 10, 2019
Estimated Study Completion Date : December 10, 2020

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  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 Outcome Measures :
  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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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%

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03986879


Contacts
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Contact: Diego GD Christofaro, PhD +551832295723 ddcleite@yahoo.com.br
Contact: Bruna TC Saraiva, MSc +5518997196380 brunatcsaraiva@gmail.com

Locations
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Brazil
Diego Giulliano Destro Christofaro Recruiting
Presidente Prudente, Sao Paulo, Brazil, 19060-900
Contact: Diego GD Christofaro, PhD    +551832295713    ddcleite@yahoo.com.br   
Sponsors and Collaborators
Bruna Thamyres Ciccotti Saraiva
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
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Principal Investigator: Diego GD Christofaro, PhD Universidade Estadual Paulista - UNESP

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Responsible Party: Bruna Thamyres Ciccotti Saraiva, Clinical Professor, Universidade Estadual Paulista Júlio de Mesquita Filho
ClinicalTrials.gov Identifier: NCT03986879     History of Changes
Other Study ID Numbers: 72191717.9.0000.5402
First Posted: June 14, 2019    Key Record Dates
Last Update Posted: July 18, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Bruna Thamyres Ciccotti Saraiva, Universidade Estadual Paulista Júlio de Mesquita Filho:
Physical Activity
Cardiovascular Health
Epidemiological