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

Primary Purpose

Arterial Hypertension

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Strength training group
Aerobic Training Group
Sponsored by
Federal University of Rio Grande do Sul
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arterial Hypertension focused on measuring hypertension, Aerobic training, Strength training

Eligibility Criteria

30 Years - 59 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Universidade Federal do Rio Grande do Sul

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Exercise training protocols

Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Blood pressure
24-h Ambulatory blood pressure
Endothelial Function
Flow mediated dilation to reactive hyperemia
Endothelium derived factors
The plasma levels of NOx and ET-1 will be determined by enzyme-linked immunosorbent assay
Inflammatory Profile
The inflammatory profile was accessed trough the cytokines and chemokines levels

Secondary Outcome Measures

Full Information

First Posted
September 12, 2017
Last Updated
September 23, 2019
Sponsor
Federal University of Rio Grande do Sul
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1. Study Identification

Unique Protocol Identification Number
NCT03282942
Brief Title
Cardiovascular Effects of Aerobic and Strength Training in Hypertensive Middle-aged Individuals
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.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
June 2, 2018 (Actual)
Primary Completion Date
June 30, 2019 (Actual)
Study Completion Date
July 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Rio Grande do Sul

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arterial Hypertension
Keywords
hypertension, Aerobic training, Strength training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise training protocols
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Strength training group
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Aerobic Training Group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Blood pressure
Description
24-h Ambulatory blood pressure
Time Frame
End of 12-week exercise period
Title
Endothelial Function
Description
Flow mediated dilation to reactive hyperemia
Time Frame
End of 12-week exercise period
Title
Endothelium derived factors
Description
The plasma levels of NOx and ET-1 will be determined by enzyme-linked immunosorbent assay
Time Frame
End of 12-week exercise period
Title
Inflammatory Profile
Description
The inflammatory profile was accessed trough the cytokines and chemokines levels
Time Frame
End of 12-week exercise period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alvaro Reischak-Oliveira, PhD
Organizational Affiliation
Federal University of Rio Grande do Sul
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidade Federal do Rio Grande do Sul
City
Porto Alegre
State/Province
Rio Grande Do Sul
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
36311227
Citation
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.
Results Reference
derived

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

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