HypertensionNCT05798975
Analysis of Heart Rate Variability After a Physical Exercise Session
A study testing Aerobic Exercise. 1 session of acute exercise, Resistance Exercise. 1 session of acute exercise and no exercise in people with Hypertension, run by Instituto de Cardiologia do Rio Grande do Sul at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 30 to 59 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Aerobic Exercise. 1 session of acute exercise, Resistance Exercise. 1 session of acute exercise and no exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Apr 2022to 30 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Controlled Systemic Alterial Hypertension
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Hypertension
- Being tested
- Aerobic Exercise. 1 session of acute exercise, Resistance Exercise. 1 session of acute exercise, no exercise
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic Exercise. 1 session of acute exerciseOther
40 minutes on cycle ergometer, 60% of heart rate reserve
Resistance Exercise. 1 session of acute exerciseOther
2 exercises for lower limbs and 2 for upper limbs with 4 sets of 12 repetitions at 60% 1-RM. 40 minutes
no exerciseOther
Rest
| Study group | Role | What they receive |
|---|---|---|
| Aerobic Physical Exercise | Experimental | Cycle ergometer exercise Receives: Other: Resistance Exercise. 1 session of acute exercise; Other: no exercise |
| Resistance Physical Exercise | Experimental | Exercise with weights Receives: Other: Aerobic Exercise. 1 session of acute exercise; Other: no exercise |
| Control | No intervention | No exercise. Rest |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart Rate Variability.
Analysis of heart rate variability with Wincardio Digital ECG.
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2023
- Study start1 Apr 2022
- Primary completion1 Oct 2024
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- AE= Aerobic Exercise RE= Resistance Exercise CT= Control (no exercise)
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Cardiologia do Rio Grande do Sul
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Diego Silveira da Silva, Instituto de Cardiologia do Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05798975
- Sponsor's protocol ID
- 5964/21
- Status last verified
- May 2025
- First submitted
- 10 Feb 2023
- Last updated
- 14 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Heart Rate Variability After One Session of Aerobic or Resistance Physical Exercise in Controlled Hypertensive Individuals: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05798975
- Acronym / sponsor ID
- 5964/21
- Conditions
- Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Instituto de Cardiologia do Rio Grande do SulUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 5 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
- Model description
- AE= Aerobic Exercise RE= Resistance Exercise CT= Control (no exercise)
| Arm | Type | Receives |
|---|---|---|
| Aerobic Physical Exercise | Experimental | Other: Resistance Exercise. 1 session of acute exercise, Other: no exerciseCycle ergometer exercise |
| Resistance Physical Exercise | Experimental | Other: Aerobic Exercise. 1 session of acute exercise, Other: no exerciseExercise with weights |
| Control | No intervention | –No exercise. Rest |
Who may qualify
- Ages
- 30 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Controlled Systemic Alterial Hypertension
Key exclusion criteria (8 listed)
- Diabetes mellitus;
- heart failure;
- coronary artery disease;
- chronic renal failure;
- body mass index (BMI) ≥ 35 kg/m2;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic Exercise. 1 session of acute exercise40 minutes on cycle ergometer, 60% of heart rate reserve | Other | Resistance Physical Exercise |
| Resistance Exercise. 1 session of acute exercise2 exercises for lower limbs and 2 for upper limbs with 4 sets of 12 repetitions at 60% 1-RM. 40 minutes | Other | Aerobic Physical Exercise |
| no exerciseRest | Other | Aerobic Physical Exercise, Resistance Physical Exercise |
Primary outcome
Heart Rate Variability.
Time frame: 4 hours
Analysis of heart rate variability with Wincardio Digital ECG.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic Exercise. 1 session of acute exercise, Resistance Exercise. 1 session of acute exercise and no exercise in people with Hypertension, run by Instituto de Cardiologia do Rio Grande do Sul at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart Rate Variability. (time frame: 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2025.