NCT03160989

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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2016

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 3, 2017

Completed
16 days until next milestone

First Posted

Study publicly available on registry

May 19, 2017

Completed
Last Updated

May 22, 2017

Status Verified

May 1, 2017

Enrollment Period

4 months

First QC Date

May 3, 2017

Last Update Submit

May 19, 2017

Conditions

Arterial Hypertension

Keywords

Blood pressure variabilityCombined physical exerciseHypertension

Outcome Measures

Primary Outcomes (1)

  • 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.

    After ten weeks and before ten weeks of exercise training

Secondary Outcomes (2)

  • Comparison resting blood pressure

    After ten weeks and before ten weeks of exercise training

  • Anthropometric assessments

    After ten weeks and before ten weeks of exercise training

Study Arms (1)

Postmenopausal and hypertensive women

EXPERIMENTAL

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.

Other: physical exercises

Interventions

physical exercisesOTHER

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.

Postmenopausal and hypertensive women

Eligibility Criteria

Age50 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 21359479BACKGROUND

  • 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.

    PMID: 18259027BACKGROUND

  • 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.

    PMID: 22666152BACKGROUND

MeSH Terms

Conditions

Hypertension

Interventions

Exercise

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • LARISSA A SANTOS MATIAS, Graduate

    Federal University of Uberlandia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
LARISSA APARECIDA SANTOS MATIAS - Principal Investigator

Study Record Dates

First Submitted

May 3, 2017

First Posted

May 19, 2017

Study Start

May 1, 2016

Primary Completion

September 1, 2016

Study Completion

December 1, 2016

Last Updated

May 22, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share