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

NCT03986879 | Completed DMC

• 1 other identifier: 72191717.9.0000.5402
• Study Type: observational
• Target: 252
• Locations: 1 country
• Sites: 1

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.

Conditions

Adult Disease

Keywords

Physical Activity; Cardiovascular Health; Epidemiological

Outcome Measures

Primary Outcomes (2)

• Cardiac autonomic modulation

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

  through study completion, an average of 1 year

• 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 Outcomes (9)

• Self-reported physical activity level questionnaire

  through study completion, an average of 1 year

• Systolic Blood pressure

  through study completion, an average of 1 year

• Diastolic Blood pressure

  through study completion, an average of 1 year

• Self-reported practice of physical activity in childhood and adolescence

  through study completion, an average of 1 year

• Resting Heart Rate

  through study completion, an average of 1 year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Bruna Thamyres Ciccotti Saraiva: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (1)

Diego Giulliano Destro Christofaro

Presidente Prudente, São Paulo, 19060-900, Brazil

Location

Related Publications (2)

• 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.

  PMID: 33483920 DERIVED

• 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.

  PMID: 31593091 DERIVED

MeSH Terms

Conditions

Disease; Motor Activity

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Diego GD Christofaro, PhD

  Universidade Estadual Paulista - UNESP

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: May 30, 2019
• First Posted: June 14, 2019
• Study Start: November 10, 2018
• Primary Completion: December 10, 2020
• Study Completion: December 10, 2020
• Last Updated: March 26, 2025

Record last verified: 2025-03

Locations

BR (1)