Analysis of Heart Rate Variability After a Physical Exercise Session

Sponsor

Instituto de Cardiologia do Rio Grande do Sul (Other)

Overall Status

Recruiting

CT.gov ID

NCT05798975

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

4.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Hypertension	Other: Aerobic Exercise. 1 session of acute exercise Other: Resistance Exercise. 1 session of acute exercise Other: no exercise	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

72 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

AE= Aerobic Exercise RE= Resistance Exercise CT= Control (no exercise)AE= Aerobic Exercise RE= Resistance Exercise CT= Control (no exercise)

Masking:

Double (Participant, Care Provider)

Primary Purpose:

Health Services Research

Official Title:

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

Actual Study Start Date :

Apr 1, 2022

Anticipated Primary Completion Date :

Jul 1, 2023

Anticipated Study Completion Date :

Sep 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Aerobic Physical Exercise Cycle ergometer exercise	Other: 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 Other: no exercise Rest
Experimental: Resistance Physical Exercise Exercise with weights	Other: Aerobic Exercise. 1 session of acute exercise 40 minutes on cycle ergometer, 60% of heart rate reserve Other: no exercise Rest
No Intervention: Control No exercise. Rest

Arm

Intervention/Treatment

Experimental: Aerobic Physical Exercise

Cycle ergometer exercise

Other: 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

Other: no exercise

Rest

Experimental: Resistance Physical Exercise

Exercise with weights

Other: Aerobic Exercise. 1 session of acute exercise

40 minutes on cycle ergometer, 60% of heart rate reserve

Other: no exercise

Rest

No Intervention: Control

No exercise. Rest

Outcome Measures

Primary Outcome Measures

Heart Rate Variability. [4 hours]
Analysis of heart rate variability with Wincardio Digital ECG.

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 59 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Diego Silveira da Silva	Porto Alegre	RS	Brazil

Sponsors and Collaborators

Instituto de Cardiologia do Rio Grande do Sul

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Diego Silveira da Silva, physical education professor., Instituto de Cardiologia do Rio Grande do Sul

ClinicalTrials.gov Identifier:

NCT05798975

Other Study ID Numbers:

5964/21

First Posted:

Apr 5, 2023

Last Update Posted:

Apr 6, 2023

Last Verified:

Apr 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Hypertension

Study Results

No Results Posted as of Apr 6, 2023