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

Adult Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03986879
• Other study ID #: 72191717.9.0000.5402
• Status: Active, not recruiting
• Start date: November 10, 2018
• Est. completion date: December 10, 2023

Study information

• Verified date: November 2023
• Source: Universidade Estadual Paulista Júlio de Mesquita Filho
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 252
• Est. completion date: December 10, 2023
• Est. primary completion date: November 10, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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%

Related Conditions & MeSH terms

• Adult Disease

Locations

Country	Name	City	State
Brazil	Diego Giulliano Destro Christofaro	Presidente Prudente	Sao Paulo

Sponsors (2)

Lead Sponsor	Collaborator
Bruna Thamyres Ciccotti Saraiva	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiac autonomic modulation	The heart rate variability will be collected by means of the POLAR V800.	through study completion, an average of 1 year
Primary	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.	through study completion, an average of 1 year
Secondary	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.	through study completion, an average of 1 year
Secondary	Systolic Blood pressure	The systolic blood pressure will be measured by means of the omron digital oscillometric device.	through study completion, an average of 1 year
Secondary	Diastolic Blood pressure	The diastolic blood pressure will be measured by means of the omron digital oscillometric device.	through study completion, an average of 1 year
Secondary	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.	through study completion, an average of 1 year
Secondary	Resting Heart Rate	The resting heart rate will be measured by means of the omron digital oscillometric device.	through study completion, an average of 1 year
Secondary	Body Mass	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
Secondary	Height	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
Secondary	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.	through study completion, an average of 1 year
Secondary	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).	through study completion, an average of 1 year