- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05798975
Analysis of Heart Rate Variability After a Physical Exercise Session
May 12, 2025 updated by: Diego Silveira da Silva, Instituto de Cardiologia do Rio Grande do Sul
Analysis of Heart Rate Variability After One Session of Aerobic or Resistance Physical Exercise in Controlled Hypertensive Individuals: Randomized Clinical Trial
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.
Study Overview
Status
Completed
Conditions
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 Type
Interventional
Enrollment (Actual)
36
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
RS
-
Porto Alegre, RS, Brazil
- Diego Silveira da Silva
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 59 years (Adult)
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Aerobic Physical Exercise
Cycle ergometer exercise
|
2 exercises for lower limbs and 2 for upper limbs with 4 sets of 12 repetitions at 60% 1-RM.
40 minutes
Rest
|
|
Experimental: Resistance Physical Exercise
Exercise with weights
|
Rest
40 minutes on cycle ergometer, 60% of heart rate reserve
|
|
No Intervention: Control
No exercise. Rest
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Heart Rate Variability.
Time Frame: 4 hours
|
Analysis of heart rate variability with Wincardio Digital ECG.
|
4 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2022
Primary Completion (Actual)
October 1, 2024
Study Completion (Actual)
November 30, 2024
Study Registration Dates
First Submitted
February 10, 2023
First Submitted That Met QC Criteria
March 22, 2023
First Posted (Actual)
April 5, 2023
Study Record Updates
Last Update Posted (Actual)
May 14, 2025
Last Update Submitted That Met QC Criteria
May 12, 2025
Last Verified
May 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5964/21
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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