HypertensionNCT02937922

Effect of Exercise on Endothelial Injury in Hypertensive Patients

A study testing AEROBIC, RESISTANCE and COMBINED in people with Hypertension and Healthy, run by Instituto de Cardiologia do Rio Grande do Sul.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 30 to 59 yearsHealthy volunteers can take part
Conditions the study is for: Hypertension, Healthy
What is being tested?: AEROBIC, RESISTANCE and COMBINED
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 33 participants
Where: No sites listed yet
Study dates: Jan 2016to Jan 2020
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
Healthy volunteers accepted
Adult

Who may be able to join

Adults with hypertension;
30 to 59 years old.

Who cannot join

Diabetes;
Heart disease;
Participating in any regular exercise program over the last six months;
Orthopedic impairments or any physical or mental limitation that prevents - achievement of physical exercise;
Body Mass Index in class II obesity or more (BMI ≥ 35 kg / m2);
Smoking.

About this study

Official title: Effect of Aerobic Exercise, Resistance or Combined in Endothelial Injury in Hypertensive Patients

Introduction: Endothelial dysfunction precedes atherosclerosis being evidenced in patients with hypertension. Increasing physical activity levels and/or physical exercise are part of the recommendations of antihypertensive therapy. However, the effects of oscillations and/or increase the systemic blood pressure induced by exercise session on endothelial function has not been studied.

Objective: To evaluate the effect of aerobic exercise, resistance exercise and combined exercise on endothelial injury levels in patients with hypertension.

Methodology: Hypertensive (n = 51) and healthy subjects (n = 30) (30-59 years old) will perform at random 40 minutes of aerobic exercise (50-60% of heart rate reserve) or 40 minutes of resistance exercise (4 x 12 repetitions of exercises for lower limbs, 60-70% of one repetition maximum and 60-90 second interval) or 40 minutes of combined exercise (20 minutes of resistance exercise and 20 minutes of aerobic exercise, in that order). Blood will be collected 10 minutes before, 10 and 60 minutes after intervention for the quantification of endothelial microparticles (MPE) circulating (induced endothelial lesion) and endothelial progenitor cells (EPC) circulating (endothelial recovery capacity) by flow cytometry. Ambulatory blood pressure monitoring (ABPM) will be held before and after the intervention. Ultrasonography is used to measure the flow-mediated dilation of the brachial artery 10 minutes before, 10, 30 and 60 minutes after the intervention.

Statistics: generalized estimating equation (GEE) for repeated measurements and Person correlation, being significant p < 0.05.

It is expected to show results to ensure cardiovascular protection in patients with hypertension caused by different types of exercise and consequent endothelial injury and release induced regenerative factors. Knowledge of the magnitude of injury and endothelial recovery provided by different types of exercise can contribute scientifically to health professionals aimed at prescribing exercise with a vascular protective vision in patients with hypertension.

Conditions: Hypertension, Healthy
Being tested: AEROBIC, RESISTANCE, COMBINED
Keywords: Exercise, Endothelium, Hypertension, Endothelial progenitor cell, Endothelial microparticle
Medical subject headings: Hypertension, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AEROBICOther
Also called Aerobic exercise
The aerobic exercise session (AE) will consist of 40 minutes on an exercise bike in heart rate (HR) corresponding to 60% of heart rate reserve (moderate intensity) acquired by the formula of Karvonen: [(HR max - HR rest) x desired intensity] + HR rest; monitored through heart monitor brand Polar and perceived exertion rating (Borg scale of 6-20). It will be added to the exercise time 5-7 minutes to proper heating.
RESISTANCEOther
Also called Resistance exercise
The resistance exercise session (RE) will last 40 minutes and will consist in carrying out 4 sets of 12 repetitions with interval of 90 seconds between sets and exercises. The weight will be adjusted to 60 % of a maximum repetition (1-RM) (moderate intensity) in four exercise for the lower limbs: leg press, knee extension, bend knees and plantar flexion (calf). The cadence of each series will be controlled by electronic metronome and performed with 2 seconds in the concentric phase and 2 seconds in the eccentric phase. It will be added to the exercise time 5-7 minutes for the warming to be held in the leg press exercise (one set of 15 to 20 repetitions with 1/3 load set for the session).
COMBINEDOther
Also called Combined exercise
The combined exercise session (resistance and aerobic) will last 40 minutes. The exercise resistance phase of the combined session will consist of 20 minutes, according to the resistance exercise described above. Immediately after resistance exercise, patients will perform aerobic exercise (AE) for 20 minutes. In order to keep the equivalent time among the three interventions (aerobic exercise, resistance and combined) will be performed two series (2 x 12 repetitions) in each resistance exercise.

Study groups in NCT02937922
Study group	Role	What they receive
AEROBIC	Active comparator	The aerobic exercise session (AE) will consist of 40 minutes on an exercise bike in heart rate (HR) corresponding to 60% of heart rate reserve (moderate intensity) acquired by the formula of Karvonen: [(HR max - HR rest) x desired intensity] + HR rest; monitored through heart monitor brand Polar and perceived exertion rating (Borg scale of 6-20). It will be added to the exercise time 5-7 minutes to proper heating. Receives: Other: AEROBIC
RESISTANCE	Active comparator	The resistance exercise session (RE) will last 40 minutes and will consist in carrying out 4 sets of 12 repetitions with interval of 90 seconds between sets and exercises. The weight will be adjusted to 60% of a maximum repetition (1-RM) in four exercise for the lower limbs: leg press, knee extension, bend knees and plantar flexion (calf). The cadence of each series will be controlled by electronic metronome and performed with 2 seconds in the concentric phase and 2 seconds in the eccentric phase. It will be added to the exercise time 5-7 minutes for the warming to be held in the leg press exercise (one set of 15 to 20 repetitions with 1/3 load set for the session). Receives: Other: RESISTANCE
COMBINED	Active comparator	The combined exercise session (resistance and aerobic) will last 40 minutes. The exercise resistance phase of the combined session will consist of 20 minutes, according to the resistance exercise described above. Immediately after resistance exercise, patients will perform aerobic exercise (AE) for 20 minutes. In order to keep the equivalent time among the three interventions (aerobic exercise resistance and combined) will be performed two series (2 x 12 repetitions) in each resistance exercise. Receives: Other: COMBINED

What is being measured

The primary outcome is the main question the study is designed to answer.

Effects of exercise on the percentage of circulating endothelial progenitor cells analyzed by flow cytometry in patients with hypertension
Measured: two years

Secondary outcomes (1)

Effects of exercise on the number of circulating endothelial microparticles analyzed by flow cytometry in patients with hypertension
Measured: two years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2016Jan 2020

First posted19 Oct 2016 (estimated)
Study startJan 2016
Primary completionDec 2019
Study completionJan 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
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: Supportive care
Allocation: Randomised
Intervention model: Factorial
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 33 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02937922
Sponsor's protocol ID: Endothelial
Status last verified: Apr 2020
First submitted: 14 Oct 2016
Last updated: 29 Apr 2020
Results posted: No
Data monitoring committee: Yes
Individual data sharing: Yes: Data will be presented to participants from lectures.

Publications

Waclawovsky G, Umpierre D, Figueira FR, De Lima ES, Alegretti AP, Schneider L, Matte US, Rodrigues TC, Schaan BD. Exercise on Progenitor Cells in Healthy Subjects and Patients with Type 1 Diabetes. Med Sci Sports Exerc. 2016 Feb;48(2):190-9. doi: 10.1249/MSS.0000000000000764.
PubMed 26312614
Amabile N, Cheng S, Renard JM, Larson MG, Ghorbani A, McCabe E, Griffin G, Guerin C, Ho JE, Shaw SY, Cohen KS, Vasan RS, Tedgui A, Boulanger CM, Wang TJ. Association of circulating endothelial microparticles with cardiometabolic risk factors in the Framingham Heart Study. Eur Heart J. 2014 Nov 7;35(42):2972-9. doi: 10.1093/eurheartj/ehu153. Epub 2014 Apr 16.
PubMed 24742886

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 29 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Aerobic Exercise, Resistance or Combined in Endothelial Injury in Hypertensive Patients
ClinicalTrials.gov ID: NCT02937922
Acronym / sponsor ID: Endothelial
Conditions: Hypertension, Healthy
Keywords: Exercise, Endothelium, Hypertension, Endothelial progenitor cell, Endothelial microparticle
Study type: Interventional
Recruitment status: Completed
Enrolment: 33 participants (actual)
Lead sponsor: Instituto de Cardiologia do Rio Grande do SulUniversity, hospital or other
Study start: Jan 2016
Primary completion: Dec 2019 (actual)
Study completion: Jan 2020 (actual)
First posted: 19 Oct 2016 (estimated)
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.

Objective: To evaluate the effect of aerobic exercise, resistance exercise and combined exercise on endothelial injury levels in patients with hypertension.

Statistics: generalized estimating equation (GEE) for repeated measurements and Person correlation, being significant p < 0.05.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Factorial
Masking: Single blind (outcomes assessor)
Number of arms: 3

Arm	Type	Receives
AEROBIC	Active comparator	Other: AEROBICThe aerobic exercise session (AE) will consist of 40 minutes on an exercise bike in heart rate (HR) corresponding to 60% of heart rate reserve (moderate intensity) acquired by the formula of Karvonen: [(HR max - HR rest) x desired intensity] + HR rest; monitored through heart monitor brand Polar and perceived exertion rating (Borg scale of 6-20). It will be added to the exercise time 5-7 minutes to proper heating.
RESISTANCE	Active comparator	Other: RESISTANCEThe resistance exercise session (RE) will last 40 minutes and will consist in carrying out 4 sets of 12 repetitions with interval of 90 seconds between sets and exercises. The weight will be adjusted to 60% of a maximum repetition (1-RM) in four exercise for the lower limbs: leg press, knee extension, bend knees and plantar flexion (calf). The cadence of each series will be controlled by electronic metronome and performed with 2 seconds in the concentric phase and 2 seconds in the eccentric phase. It will be added to the exercise time 5-7 minutes for the warming to be held in the leg press exercise (one set of 15 to 20 repetitions with 1/3 load set for the session).
COMBINED	Active comparator	Other: COMBINEDThe combined exercise session (resistance and aerobic) will last 40 minutes. The exercise resistance phase of the combined session will consist of 20 minutes, according to the resistance exercise described above. Immediately after resistance exercise, patients will perform aerobic exercise (AE) for 20 minutes. In order to keep the equivalent time among the three interventions (aerobic exercise resistance and combined) will be performed two series (2 x 12 repetitions) in each resistance exercise.

Who may qualify

Ages: 30 to 59 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (2 listed)

Adults with hypertension;
30 to 59 years old.

Key exclusion criteria (6 listed)

Diabetes;
Heart disease;
Participating in any regular exercise program over the last six months;
Orthopedic impairments or any physical or mental limitation that prevents - achievement of physical exercise;
Body Mass Index in class II obesity or more (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
AEROBICAlso: Aerobic exerciseThe aerobic exercise session (AE) will consist of 40 minutes on an exercise bike in heart rate (HR) corresponding to 60% of heart rate reserve (moderate intensity) acquired by the formula of Karvonen: [(HR max - HR rest) x desired intensity] + HR rest; monitored through heart monitor brand Polar and perceived exertion rating (Borg scale of 6-20). It will be added to the exercise time 5-7 minutes to proper heating.	Other	AEROBIC
RESISTANCEAlso: Resistance exerciseThe resistance exercise session (RE) will last 40 minutes and will consist in carrying out 4 sets of 12 repetitions with interval of 90 seconds between sets and exercises. The weight will be adjusted to 60 % of a maximum repetition (1-RM) (moderate intensity) in four exercise for the lower limbs: leg press, knee extension, bend knees and plantar flexion (calf). The cadence of each series will be controlled by electronic metronome and performed with 2 seconds in the concentric phase and 2 seconds in the eccentric phase. It will be added to the exercise time 5-7 minutes for the warming to be held in the leg press exercise (one set of 15 to 20 repetitions with 1/3 load set for the session).	Other	RESISTANCE
COMBINEDAlso: Combined exerciseThe combined exercise session (resistance and aerobic) will last 40 minutes. The exercise resistance phase of the combined session will consist of 20 minutes, according to the resistance exercise described above. Immediately after resistance exercise, patients will perform aerobic exercise (AE) for 20 minutes. In order to keep the equivalent time among the three interventions (aerobic exercise, resistance and combined) will be performed two series (2 x 12 repetitions) in each resistance exercise.	Other	COMBINED

Primary outcome

Effects of exercise on the percentage of circulating endothelial progenitor cells analyzed by flow cytometry in patients with hypertension
Time frame: two years

1 secondary outcome

Effects of exercise on the number of circulating endothelial microparticles analyzed by flow cytometry in patients with hypertension
Time frame: two years

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 29 Apr 2020.
Background: PubMed 26312614Waclawovsky G, Umpierre D, Figueira FR, De Lima ES, Alegretti AP, Schneider L, Matte US, Rodrigues TC, Schaan BD. Exercise on Progenitor Cells in Healthy Subjects and Patients with Type 1 Diabetes. Med Sci Sports Exerc. 2016 Feb;48(2):190-9. doi: 10.1249/MSS.0000000000000764.
Background: PubMed 24742886Amabile N, Cheng S, Renard JM, Larson MG, Ghorbani A, McCabe E, Griffin G, Guerin C, Ho JE, Shaw SY, Cohen KS, Vasan RS, Tedgui A, Boulanger CM, Wang TJ. Association of circulating endothelial microparticles with cardiometabolic risk factors in the Framingham Heart Study. Eur Heart J. 2014 Nov 7;35(42):2972-9. doi: 10.1093/eurheartj/ehu153. Epub 2014 Apr 16.
Individual participant dataSharing planned: Yes. Data will be presented to participants from lectures.

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Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
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An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
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Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
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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.

Questions about this trial

What is this clinical trial studying?

A study testing AEROBIC, RESISTANCE and COMBINED in people with Hypertension and Healthy, run by Instituto de Cardiologia do Rio Grande do Sul.

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 2 inclusion and 6 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 29 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

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?

Effects of exercise on the percentage of circulating endothelial progenitor cells analyzed by flow cytometry in patients with hypertension (time frame: two years). 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 NCT02937922, which also lists 2 linked publications.

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 29 Apr 2020.