- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03160989
Acute and Chronic Responses to Blood Pressure After Exercise
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Before starting the training program, all the volunteers will sign the Free and Informed Consent Form (TCLE) and must present a medical certificate releasing the participation. In addition, the volunteers will respond to an anamnesis questionnaire and will undergo an anthropometric evaluation before the experimental sessions. The physical exercise program will be held three times a week for 10 weeks, containing aerobic exercise (exercise treadmill) and resistance exercises (bodybuilding). Initially, a familiarization of the ergometers used will be performed, followed by a session to evaluate the intensity of resistance exercise through a maximal repetition test (1RM), and a session to evaluate aerobic fitness through an incremental treadmill test.
Before starting the training, volunteers will perform a single exercise session, following the same exercise protocol. All the volunteers will be submitted to the evaluation of the blood pressure during 24 hours through the measurement of ambulatory blood pressure (ABPM) in three moments:
- PR: pre-training rest - the volunteers will arrive at the laboratory, will be in rest for 15 minutes and after that they will place the ABPM, without having done any exercise.
- PE: post exercise - upon arriving at the laboratory, the volunteers will be submitted to a single combined exercise session, will have a maximum interval of 20 minutes for the bath and will place the MAP device.
- CR: rest after chronic training - after the end of the 10 weeks of training, the volunteers will be submitted to ABPM, again at rest, with a maximum interval of 72 hours, between the end of the training and the placement of the device.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Women aged between 50 and 70 years;
- Be in the postmenopausal phase;
- Be able to practice physical exercise on treadmill and resistance exercises (bodybuilding).
- Present stage 1 hypertension, according to the guidelines of the Brazilian Society of Hypertension
- Make use of anti-hypertensive medication, except beta-blockers
- Participants should be evaluated with a cardiologist beforehand and present a certificate attesting that they are able to perform physical activities.
- Do not present physical problems or cardiovascular complications that prevent the performance of physical exercises.
Exclusion Criteria:
- Make use of beta-blockers
- Present history of stroke or acute myocardial infarction;
- Smoking;
- Present diagnosis of Diabetes Mellitus.
- Present renal pathologies
- Use hormone replacement therapies
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Postmenopausal and hypertensive women
The intervention will consist of a single session and after ten weeks of combined physical exercises (aerobic and resisted).
All volunteers will participate in the same procedure.
|
The intervention will consist of a single session and after ten weeks of combined physical exercises (aerobic and resisted).
All volunteers will participate in the same procedure.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in ambulatory blood pressure variability in ten weeks
Time Frame: After ten weeks and before ten weeks of exercise training
|
The ambulatory blood pressure measurement will be performed for 24 hours.
With the information obtained in this measurement, blood pressure variability will be performed.
|
After ten weeks and before ten weeks of exercise training
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Comparison resting blood pressure
Time Frame: After ten weeks and before ten weeks of exercise training
|
The resting blood pressure is performed after 15 minutes of sitting, measured three times and the mean is calculated for analysis
|
After ten weeks and before ten weeks of exercise training
|
Anthropometric assessments
Time Frame: After ten weeks and before ten weeks of exercise training
|
Body composition of the volunteers
|
After ten weeks and before ten weeks of exercise training
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: LARISSA A SANTOS MATIAS, Graduate, Federal University of Uberlandia
Publications and helpful links
General Publications
- Gomes Anunciacao P, Doederlein Polito M. A review on post-exercise hypotension in hypertensive individuals. Arq Bras Cardiol. 2011 May;96(5):e100-109. Epub 2011 Mar 4. English, Portuguese, Spanish.
- Coylewright M, Reckelhoff JF, Ouyang P. Menopause and hypertension: an age-old debate. Hypertension. 2008 Apr;51(4):952-9. doi: 10.1161/HYPERTENSIONAHA.107.105742. Epub 2008 Feb 7. No abstract available.
- Puga GM, Kokubun E, Simoes HG, Nakamura FY, Campbell CS. Aerobic fitness evaluation during walking tests identifies the maximal lactate steady state. ScientificWorldJournal. 2012;2012:769431. doi: 10.1100/2012/769431. Epub 2012 May 1.
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
- CEP UFU 002095/
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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