- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03282942
Cardiovascular Effects of Aerobic and Strength Training in Hypertensive Middle-aged Individuals
Effects of Aerobic or Strength Training on Cardiovascular, Endothelial Response, and Blood Flow in Hypertensive Middle Ages Individuals: a Randomized Controlled Clinical Trial.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Rio Grande Do Sul
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Porto Alegre, Rio Grande Do Sul, Brazil
- Universidade Federal do Rio Grande do Sul
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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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.
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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:
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Blood pressure
Time Frame: End of 12-week exercise period
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24-h Ambulatory blood pressure
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End of 12-week exercise period
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Endothelial Function
Time Frame: End of 12-week exercise period
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Flow mediated dilation to reactive hyperemia
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End of 12-week exercise period
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Endothelium derived factors
Time Frame: End of 12-week exercise period
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The plasma levels of NOx and ET-1 will be determined by enzyme-linked immunosorbent assay
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End of 12-week exercise period
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Inflammatory Profile
Time Frame: End of 12-week exercise period
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The inflammatory profile was accessed trough the cytokines and chemokines levels
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End of 12-week exercise period
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Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 69373217.3.0000.5347
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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