Clinical trial NCT03986879: Relationship of the Physical Activity Practice and Its Different Domains With Cardiac Autonomic Modulation
Official title: Relationship of the Intensity of Physical Activity Practice and Its Different Domains With Cardiac Autonomic Modulation in Adult Individuals
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adult Disease
Keywords: Physical Activity
Cardiovascular Health
Epidemiological
Lead sponsor: Universidade Estadual Paulista Júlio de Mesquita Filho
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2019-06-14
Enrollment: 252
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
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.

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.

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.

Eligibility 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%

Primary outcomes:
measure: Cardiac autonomic modulation
timeFrame: through study completion, an average of 1 year
measure: Physical activity level - objective measure
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Self-reported physical activity level questionnaire
timeFrame: through study completion, an average of 1 year
measure: Systolic Blood pressure
timeFrame: through study completion, an average of 1 year
measure: Diastolic Blood pressure
timeFrame: through study completion, an average of 1 year
measure: Self-reported practice of physical activity in childhood and adolescence
timeFrame: through study completion, an average of 1 year
measure: Resting Heart Rate
timeFrame: through study completion, an average of 1 year
measure: Body Mass
timeFrame: through study completion, an average of 1 year
measure: Height
timeFrame: through study completion, an average of 1 year
measure: Body Mass Index
timeFrame: through study completion, an average of 1 year
measure: Waist Circumference
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Presidente Prudente
country: Brazil
facility: Diego Giulliano Destro Christofaro
state: Sao Paulo
Study officials:
affiliation: Universidade Estadual Paulista - UNESP
name: Diego GD Christofaro, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.