search
Back to results

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
Federal University of Uberlandia
About
Eligibility
Locations
Arms
Outcomes
Full info

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

50 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

    First Posted
    May 3, 2017
    Last Updated
    May 19, 2017
    Sponsor
    Federal University of Uberlandia
    search

    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