Analysis of Heart Rate Variability After a Physical Exercise Session

Hypertension Clinical Trial

Official title:

Analysis of Heart Rate Variability After One Session of Aerobic or Resistance Physical Exercise in Controlled Hypertensive Individuals: Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05798975
• Other study ID #: 5964/21
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2022
• Est. completion date: July 30, 2024

Study information

• Verified date: May 2024
• Source: Instituto de Cardiologia do Rio Grande do Sul
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Systemic arterial hypertension (SAH) is a multifactorial clinical condition, characterized by sustained elevation of blood pressure levels, contributing to 50% of deaths from cardiovascular disease. The Autonomic Nervous System (ANS) plays a fundamental role in the regulation of Blood Pressure (BP) and is closely associated with Heart Rate (HR). HR changes are called Heart Rate Variability (HRV). In individuals with SAH, HRV indices are reduced compared to normotensive individuals, showing changes in autonomic modulation, thus increasing the risk for cardiovascular events. The objective of this study will be to analyze the Heart Rate Variability in individuals with controlled SAH after a session of aerobic (EA) or resistance (RE) physical exercise.

Description:

Controlled hypertensive individuals aged between 30 and 59 years will be selected, for convenience, who use the services of the Instituto de Cardiologia do Rio Grande do Sul. Volunteers will be randomly assigned to an EA session (40 minutes on cycle ergometer, 60% of heart rate reserve) or RE (2 exercises for lower limbs and 2 for upper limbs with 4 sets of 12 repetitions at 60% 1-RM) or control group without exercise. HRV data will be collected by ECG (Wincardio USB - Version 11.1.0.0, MICROMED Biotecnologia Ltda, Brasília - DF - Brazil) during 10 minutes before the exercise session, 10 minutes after the exercise session, 1h and 2h post-session . It is expected to estimate results that may demonstrate clarifications about the impact of a physical exercise session on HRV in controlled hypertensive individuals.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: July 30, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 59 Years

Eligibility

Inclusion Criteria:

• Controlled Systemic Alterial Hypertension

Exclusion Criteria:

• Diabetes mellitus;

• heart failure;

• coronary artery disease;

• chronic renal failure;

• body mass index (BMI) = 35 kg/m2;

• smokers;

• individuals with injuries to the upper and lower limbs that make the exercise protocol impossible;

• not using antihypertensive medication and using beta-blocker and/or alpha-blocker medication.

Related Conditions & MeSH terms

• Hypertension

Intervention

Other:
• Aerobic Exercise. 1 session of acute exercise
40 minutes on cycle ergometer, 60% of heart rate reserve
• Resistance Exercise. 1 session of acute exercise
2 exercises for lower limbs and 2 for upper limbs with 4 sets of 12 repetitions at 60% 1-RM. 40 minutes
• no exercise
Rest

Locations

Country	Name	City	State
Brazil	Diego Silveira da Silva	Porto Alegre	RS

Sponsors (1)

Lead Sponsor	Collaborator
Instituto de Cardiologia do Rio Grande do Sul

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart Rate Variability.	Analysis of heart rate variability with Wincardio Digital ECG.	4 hours