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CompletedNCT03282942Updated Sep 26, 2019

Cardiovascular Effects of Aerobic and Strength Training in Hypertensive Middle-aged Individuals

An interventional study of Strength training group and Aerobic Training Group in Arterial Hypertension, sponsored by Federal University of Rio Grande do Sul. Completed at 1 site in Brazil. Open to participants aged 30 Years to 59 Years. Per ClinicalTrials.gov, last updated 2019-09-26.

Sponsored by Federal University of Rio Grande do Sul · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
30 Years to 59 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Arterial Hypertension

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Keywords

  • hypertension
  • Aerobic training
  • Strength training
03

Who can participate

Ages eligible
30 Years to 59 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

Study inclusion criteria consisted of the following: 1) Individuals should use antihypertensive medication; 2) 30-59 years of age.

Exclusion criteria

Exclusion Criteria:

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.

04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Single (Outcomes assessor)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    Exercise training protocols

    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 group · Other: Aerobic Training Group

  • No intervention
    Control Group

    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

  • OtherStrength training group

    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

  • OtherAerobic Training Group

    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.

05

What researchers measure

Primary outcomes

  1. Blood pressure

    24-h Ambulatory blood pressure

    Time frame: End of 12-week exercise period

  2. Endothelial Function

    Flow mediated dilation to reactive hyperemia

    Time frame: End of 12-week exercise period

  3. Endothelium derived factors

    The plasma levels of NOx and ET-1 will be determined by enzyme-linked immunosorbent assay

    Time frame: End of 12-week exercise period

  4. Inflammatory Profile

    The inflammatory profile was accessed trough the cytokines and chemokines levels

    Time frame: End of 12-week exercise period

06

Study locations

1 site
  • Universidade Federal do Rio Grande do Sul
    Porto Alegre, Rio Grande Do Sul, Brazil
07

References and documents

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 ↗
08

Registry details

Key details

Study ID
NCT03282942
Lead sponsor
Federal University of Rio Grande do Sul
Responsible party
Alvaro Reischak-Oliveira (Principal Investigator, Federal University of Rio Grande do Sul) — Principal investigator
First posted
Sep 14, 2017
Start date
Jun 2, 2018
Primary completion
Jun 30, 2019
Completion
Jul 30, 2019
Last update
Sep 26, 2019

Study contacts

Alvaro Reischak-Oliveira, PhD
principal investigator · Federal University of Rio Grande do Sul

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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