Analysis of Heart Rate Variability After a Physical Exercise Session
Primary Purpose
Hypertension
Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Aerobic Exercise. 1 session of acute exercise
Resistance Exercise. 1 session of acute exercise
no exercise
Sponsored by
About this trial
This is an interventional health services research trial for Hypertension
Eligibility Criteria
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.
Sites / Locations
- Diego Silveira da SilvaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
Aerobic Physical Exercise
Resistance Physical Exercise
Control
Arm Description
Cycle ergometer exercise
Exercise with weights
No exercise. Rest
Outcomes
Primary Outcome Measures
Heart Rate Variability.
Analysis of heart rate variability with Wincardio Digital ECG.
Secondary Outcome Measures
Full Information
NCT ID
NCT05798975
First Posted
February 10, 2023
Last Updated
August 18, 2023
Sponsor
Instituto de Cardiologia do Rio Grande do Sul
1. Study Identification
Unique Protocol Identification Number
NCT05798975
Brief Title
Analysis of Heart Rate Variability After a Physical Exercise Session
Official Title
Analysis of Heart Rate Variability After One Session of Aerobic or Resistance Physical Exercise in Controlled Hypertensive Individuals: Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
August 1, 2023 (Actual)
Study Completion Date
October 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto de Cardiologia do Rio Grande do Sul
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
AE= Aerobic Exercise RE= Resistance Exercise CT= Control (no exercise)
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
72 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Aerobic Physical Exercise
Arm Type
Experimental
Arm Description
Cycle ergometer exercise
Arm Title
Resistance Physical Exercise
Arm Type
Experimental
Arm Description
Exercise with weights
Arm Title
Control
Arm Type
No Intervention
Arm Description
No exercise. Rest
Intervention Type
Other
Intervention Name(s)
Aerobic Exercise. 1 session of acute exercise
Intervention Description
40 minutes on cycle ergometer, 60% of heart rate reserve
Intervention Type
Other
Intervention Name(s)
Resistance Exercise. 1 session of acute exercise
Intervention Description
2 exercises for lower limbs and 2 for upper limbs with 4 sets of 12 repetitions at 60% 1-RM. 40 minutes
Intervention Type
Other
Intervention Name(s)
no exercise
Intervention Description
Rest
Primary Outcome Measure Information:
Title
Heart Rate Variability.
Description
Analysis of heart rate variability with Wincardio Digital ECG.
Time Frame
4 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Diego Silveira da Silva
City
Porto Alegre
State/Province
RS
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Silva Diego, Educ. Física
Phone
51996680195
Email
dieguitoef@hotmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Analysis of Heart Rate Variability After a Physical Exercise Session
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