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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03282942
Other study ID # 69373217.3.0000.5347
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 2, 2018
Est. completion date July 30, 2019

Study information

Verified date September 2019
Source Federal University of Rio Grande do Sul
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date July 30, 2019
Est. primary completion date June 30, 2019
Accepts healthy volunteers No
Gender All
Age group 30 Years to 59 Years
Eligibility Inclusion Criteria:

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

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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Strength 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
Aerobic 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.

Locations

Country Name City State
Brazil Universidade Federal do Rio Grande do Sul Porto Alegre Rio Grande Do Sul

Sponsors (1)

Lead Sponsor Collaborator
Federal University of Rio Grande do Sul

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Blood pressure 24-h Ambulatory blood pressure End of 12-week exercise period
Primary Endothelial Function Flow mediated dilation to reactive hyperemia End of 12-week exercise period
Primary 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
Primary Inflammatory Profile The inflammatory profile was accessed trough the cytokines and chemokines levels End of 12-week exercise period
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