Acute and Chronic Responses to Blood Pressure After Exercise
Primary Purpose
Arterial Hypertension
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
physical exercises
Sponsored by

About this trial
This is an interventional health services research trial for Arterial Hypertension focused on measuring Blood pressure variability, Combined physical exercise, Hypertension
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Postmenopausal and hypertensive women
Arm Description
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.
Outcomes
Primary Outcome Measures
Change in ambulatory blood pressure variability in ten weeks
The ambulatory blood pressure measurement will be performed for 24 hours. With the information obtained in this measurement, blood pressure variability will be performed.
Secondary Outcome Measures
Comparison resting blood pressure
The resting blood pressure is performed after 15 minutes of sitting, measured three times and the mean is calculated for analysis
Anthropometric assessments
Body composition of the volunteers
Full Information
NCT ID
NCT03160989
First Posted
May 3, 2017
Last Updated
May 19, 2017
Sponsor
Federal University of Uberlandia
1. Study Identification
Unique Protocol Identification Number
NCT03160989
Brief Title
Acute and Chronic Responses to Blood Pressure After Exercise
Official Title
Acute and Chronic Responses to Blood Pressure After Exercise
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
May 2016 (Actual)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Uberlandia
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
The study will evaluate the variability of blood pressure in postmenopausal and hypertensive women after only one session and after training of ten weeks of combined physical exercises (aerobic and resisted).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arterial Hypertension
Keywords
Blood pressure variability, Combined physical exercise, Hypertension
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Postmenopausal and hypertensive women
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
physical exercises
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in ambulatory blood pressure variability in ten weeks
Description
The ambulatory blood pressure measurement will be performed for 24 hours. With the information obtained in this measurement, blood pressure variability will be performed.
Time Frame
After ten weeks and before ten weeks of exercise training
Secondary Outcome Measure Information:
Title
Comparison resting blood pressure
Description
The resting blood pressure is performed after 15 minutes of sitting, measured three times and the mean is calculated for analysis
Time Frame
After ten weeks and before ten weeks of exercise training
Title
Anthropometric assessments
Description
Body composition of the volunteers
Time Frame
After ten weeks and before ten weeks of exercise training
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
LARISSA A SANTOS MATIAS, Graduate
Organizational Affiliation
Federal University of Uberlandia
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
21359479
Citation
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.
Results Reference
background
PubMed Identifier
18259027
Citation
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.
Results Reference
background
PubMed Identifier
22666152
Citation
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.
Results Reference
background
Learn more about this trial
Acute and Chronic Responses to Blood Pressure After Exercise
We'll reach out to this number within 24 hrs