Arterial HypertensionNCT03282942
Cardiovascular Effects of Aerobic and Strength Training in Hypertensive Middle-aged Individuals
A study testing Strength training group and Aerobic Training Group in people with Arterial Hypertension, run by Federal University of Rio Grande do Sul at 1 site in Brazil.
Trial summary
Systemic arterial hypertension (SAH) is characterized by elevated and sustained blood pressure levels, related to several risk factors. Modifying lifestyle to combat risk factors associated with cardiovascular disease is critical, as such factors are related alteration of endothelial vasodilator response leading to… Read more about this study
- Who is it for?
- Ages 30 to 59 years
- Conditions the study is for
- Arterial Hypertension
- What is being tested?
- Strength training group and Aerobic Training Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- 2 Jun 2018to 30 Jul 2019
- 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
- Study inclusion criteria consisted of the following: 1) Individuals should use antihypertensive medication; 2) 30-59 years of age.
Who cannot join
- The following aspects were regarded as exclusion criteria: 1) body mass index (BMI) up to 40 kg/m2; 2) regular engagement in any type of physical exercise training in the past 6 months prior to inclusion in the study; 3) symptomatic peripheral arterial occlusive disease; 4) aortic insufficiency or stenosis more than stage I; 5) hypertrophic obstructive cardiomyopathy; 6) congestive heart failure (>NYHA II); 7) uncontrolled cardiac arrhythmia with hemodynamic relevance; 7) change of antihypertensive medication in the past 4 weeks prior to inclusion in the study; 8) indication of unstable coronary artery disease. 9) use of tobacco products.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Universidade Federal do Rio Grande do Sul
Porto Alegre, Rio Grande do Sul
About this study
Official title: Effects of Aerobic or Strength Training on Cardiovascular, Endothelial Response, and Blood Flow in Hypertensive Middle Ages Individuals: a Randomized Controlled Clinical Trial.
Systemic arterial hypertension (SAH) is characterized by elevated and sustained blood pressure levels, related to several risk factors. Modifying lifestyle to combat risk factors associated with cardiovascular disease is critical, as such factors are related alteration of endothelial vasodilator response leading to progressive loss of its protective function. However, endothelial dysfunction related to hypertension is not only related to the decrease in the bioavailability of endothelium relaxants, but also to the time of presence of hypertension, increased production of vessel contraction factors and oxidative stress related to the disease. In this way, physical training presents as a non-drug strategy capable of directly and indirectly influencing the pathophysiology of hypertension. In this way the objective of the present work will be to evaluate the acute and chronic effect of aerobic exercise and strength on blood pressure, blood markers of vasodilation and vascular endothelial vasoconstriction, as well as the repercussion on flow-mediated dilatation and oxidative stress markers, In middle-aged hypertensive individuals before and after 12 weeks of training. Study hypothesis: The expected results of the research are that the endothelial response of biochemical markers of vasodilation and vasoconstriction will change positively after aerobic and strength training and the responses will be similar when compared between groups. There will be an improvement in the antioxidant capacity in both groups and the magnitude of the hypotensive effect will be greater in the aerobic group when compared to control and strength.
- Conditions
- Arterial Hypertension
- Being tested
- Strength training group, Aerobic Training Group
- Keywords
- hypertension, Aerobic training, Strength training
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strength training groupOther
Individuals in the strength training group will perform exercises based on exercises with free weights and equipment, for upper and lower limbs with a weekly frequency of three times for twelve weeks. The periodization will start with 2 sets, 15 - 20 repetitions, passive rest of 120 seconds, exercises performed alternating by segments and the intensity of 50% of maximum repetition. After twelve weeks the periodization will be finished with 3 sets, 8-12 repetitions, passive rest of 120 seconds, exercises performed alternated by segments and the intensity of 70% of maximum repetition.
The following exercises will compose the strength training protocol:
- Squatting
- Leg press
- Knee Extension
- Knee Flexion
- Supine Challenge
- High Pull
- Elbow flexion
- Extension of elbows
- Development
- Abdominal
Aerobic Training GroupOther
Individuals in the aerobic training group will perform aerobic treadmill exercise three times a week for twelve weeks. The training prescription will be performed through the percentage of maximum oxygen consumption with intensity in 60% to 80% with an average duration of 50 minutes of continuous exercise.
| Study group | Role | What they receive |
|---|---|---|
| Exercise training protocols | Experimental | Participants will be randomized in one of TWO groups: aerobic training group (AT) or strength training group (ST). Each training protocol will last 12 weeks, being the initial two weeks designed to participants' gradual adaptations to respective training protocol, with sessions performed three times per week in non-consecutive days. Receives: Other: Strength training group; Other: Aerobic Training Group |
| Control Group | No intervention | The individuals who will be part of the control group will be instructed to follow their daily activities, avoiding any systematic exercise program and return to the end of the 12 weeks for reevaluation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure
24-h Ambulatory blood pressure
Measured: End of 12-week exercise period
Endothelial Function
Flow mediated dilation to reactive hyperemia
Measured: End of 12-week exercise period
Endothelium derived factors
The plasma levels of NOx and ET-1 will be determined by enzyme-linked immunosorbent assay
Measured: End of 12-week exercise period
Inflammatory Profile
The inflammatory profile was accessed trough the cytokines and chemokines levels
Measured: End of 12-week exercise period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2017
- Study start2 Jun 2018
- Primary completion30 Jun 2019
- Study completion30 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Arterial 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Rio Grande do Sul
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alvaro Reischak-Oliveira, Federal University of Rio Grande do Sul
- Investigators
- Alvaro Reischak-Oliveira, PhD, Principal investigator, Federal University of Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03282942
- Sponsor's protocol ID
- 69373217.3.0000.5347
- Status last verified
- Sep 2019
- First submitted
- 12 Sep 2017
- Last updated
- 26 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ramis TR, Boeno FP, Leal-Menezes R, Munhoz SV, Farinha JB, Ribeiro JL, Reischak-Oliveira A. Effects of exercise modalities on decreased blood pressure in patients with hypertension. Front Physiol. 2022 Oct 14;13:993258. doi: 10.3389/fphys.2022.993258. eCollection 2022.
PubMed 36311227
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Aerobic or Strength Training on Cardiovascular, Endothelial Response, and Blood Flow in Hypertensive Middle Ages Individuals: a Randomized Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT03282942
- Acronym / sponsor ID
- 69373217.3.0000.5347
- Conditions
- Arterial Hypertension
- Keywords
- hypertension, Aerobic training, Strength training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Federal University of Rio Grande do SulUniversity, hospital or other
- Study start
- 2 Jun 2018 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jul 2019 (actual)
- First posted
- 14 Sep 2017 (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 characterized by elevated and sustained blood pressure levels, related to several risk factors. Modifying lifestyle to combat risk factors associated with cardiovascular disease is critical, as such factors are related alteration of endothelial vasodilator response leading to progressive loss of its protective function. However, endothelial dysfunction related to hypertension is not only related to the decrease in the bioavailability of endothelium relaxants, but also to the time of presence of hypertension, increased production of vessel contraction factors and oxidative stress related to the disease. In this way, physical training presents as a non-drug strategy capable of directly and indirectly influencing the pathophysiology of hypertension. In this way the objective of the present work will be to evaluate the acute and chronic effect of aerobic exercise and strength on blood pressure, blood markers of vasodilation and vascular endothelial vasoconstriction, as well as the repercussion on flow-mediated dilatation and oxidative stress markers, In middle-aged hypertensive individuals before and after 12 weeks of training. Study hypothesis: The expected results of the research are that the endothelial response of biochemical markers of vasodilation and vasoconstriction will change positively after aerobic and strength training and the responses will be similar when compared between groups. There will be an improvement in the antioxidant capacity in both groups and the magnitude of the hypotensive effect will be greater in the aerobic group when compared to control and strength.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise training protocols | Experimental | Other: Strength training group, Other: Aerobic Training GroupParticipants will be randomized in one of TWO groups: aerobic training group (AT) or strength training group (ST). Each training protocol will last 12 weeks, being the initial two weeks designed to participants' gradual adaptations to respective training protocol, with sessions performed three times per week in non-consecutive days. |
| Control Group | No intervention | –The individuals who will be part of the control group will be instructed to follow their daily activities, avoiding any systematic exercise program and return to the end of the 12 weeks for reevaluation. |
Who may qualify
- Ages
- 30 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Study inclusion criteria consisted of the following: 1) Individuals should use antihypertensive medication; 2) 30-59 years of age.
Key exclusion criteria (1 listed)
- The following aspects were regarded as exclusion criteria: 1) body mass index (BMI) up to 40 kg/m2; 2) regular engagement in any type of physical exercise training in the past 6 months prior to inclusion in the study; 3) symptomatic peripheral arterial occlusive disease; 4) aortic insufficiency or stenosis more than stage I; 5) hypertrophic obstructive cardiomyopathy; 6) congestive heart failure (>NYHA II); 7) uncontrolled cardiac arrhythmia with hemodynamic relevance; 7) change of antihypertensive medication in the past 4 weeks prior to inclusion in the study; 8) indication of unstable coronary artery disease. 9) use of tobacco products.
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 |
|---|---|---|
| Strength training groupIndividuals in the strength training group will perform exercises based on exercises with free weights and equipment, for upper and lower limbs with a weekly frequency of three times for twelve weeks. The periodization will start with 2 sets, 15 - 20 repetitions, passive rest of 120 seconds, exercises performed alternating by segments and the intensity of 50% of maximum repetition. After twelve weeks the periodization will be finished with 3 sets, 8-12 repetitions, passive rest of 120 seconds, exercises performed alternated by segments and the intensity of 70% of maximum repetition. The following exercises will compose the strength training protocol: * Squatting * Leg press * Knee Extension * Knee Flexion * Supine Challenge * High Pull * Elbow flexion * Extension of elbows * Development * Abdominal | Other | Exercise training protocols |
| Aerobic Training GroupIndividuals in the aerobic training group will perform aerobic treadmill exercise three times a week for twelve weeks. The training prescription will be performed through the percentage of maximum oxygen consumption with intensity in 60% to 80% with an average duration of 50 minutes of continuous exercise. | Other | Exercise training protocols |
Primary outcome
Blood pressure
Time frame: End of 12-week exercise period
24-h Ambulatory blood pressure
Endothelial Function
Time frame: End of 12-week exercise period
Flow mediated dilation to reactive hyperemia
Endothelium derived factors
Time frame: End of 12-week exercise period
The plasma levels of NOx and ET-1 will be determined by enzyme-linked immunosorbent assay
Inflammatory Profile
Time frame: End of 12-week exercise period
The inflammatory profile was accessed trough the cytokines and chemokines levels
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 26 Sep 2019.
- Derived from this study: PubMed 36311227Ramis TR, Boeno FP, Leal-Menezes R, Munhoz SV, Farinha JB, Ribeiro JL, Reischak-Oliveira A. Effects of exercise modalities on decreased blood pressure in patients with hypertension. Front Physiol. 2022 Oct 14;13:993258. doi: 10.3389/fphys.2022.993258. eCollection 2022.
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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.
Alvaro Reischak-Oliveira, PhD principal investigator
Federal University of Rio Grande do Sul
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strength training group and Aerobic Training Group in people with Arterial Hypertension, run by Federal University of 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 1 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 26 Sep 2019. 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?
Blood pressure (time frame: End of 12-week exercise period). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03282942, which also lists 1 linked publication.
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 26 Sep 2019.