NCT03282942

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 12, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 14, 2017

Completed
9 months until next milestone

Study Start

First participant enrolled

June 2, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2019

Completed
Last Updated

September 26, 2019

Status Verified

September 1, 2019

Enrollment Period

1.1 years

First QC Date

September 12, 2017

Last Update Submit

September 23, 2019

Conditions

Keywords

hypertensionAerobic trainingStrength training

Outcome Measures

Primary Outcomes (4)

  • Blood pressure

    24-h Ambulatory blood pressure

    End of 12-week exercise period

  • Endothelial Function

    Flow mediated dilation to reactive hyperemia

    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

    End of 12-week exercise period

  • Inflammatory Profile

    The inflammatory profile was accessed trough the cytokines and chemokines levels

    End of 12-week exercise period

Study Arms (2)

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.

Other: Strength training groupOther: 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.

Interventions

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

Exercise training protocols

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.

Exercise training protocols

Eligibility Criteria

Age30 Years - 59 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade Federal do Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, Brazil

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Alvaro Reischak-Oliveira, PhD

    Federal University of Rio Grande do Sul

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 12, 2017

First Posted

September 14, 2017

Study Start

June 2, 2018

Primary Completion

June 30, 2019

Study Completion

July 30, 2019

Last Updated

September 26, 2019

Record last verified: 2019-09

Locations