Effects of Training Based on the Pilates Method on the Blood Pressure of Hypertensive Women

March 24, 2020 updated by: João Luiz Q. Durigan

Blood Pressure, Autonomic Heart Rate Modulation, Cardiorespiratory Parameters, Functionality and Quality of Life in Hypertensive Women After 16 Weeks of Training Based on the Pilates Method

The main objective of this study is to evaluate and compare the effect of the Pilates method associated with aerobic exercise and the traditional Pilates method on the blood pressure of hypertensive medicated women. In addition, we aim to analyze and compare the chronic effects of training on cardiac autonomic modulation, on cardiorespiratory fitness, functionality and quality of life.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Subjects will be allocated randomly in three groups: (1) Traditional Pilates group, which will perform only exercises based on the traditional Pilates method, (2) Modified Pilates group, which will perform exercises based on the Pilates method alternated with active rest periods on treadmill ergometer, (3) Control group: will not perform any physical exercise during the trial period. The sessions will be performed two times a week, during 16 weeks. Subjects will be evaluated before and after 16 weeks of intervention.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Distrito Federal
      • Brasília, Distrito Federal, Brazil, 72220-900
        • University of Brasilia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 59 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Hypertensive women
  • Age 30 to 59
  • Sedentary or who do not practice any form of physical exercise regularly for at least 6 months
  • Make use of antihypertensive medication
  • Who have medical clearance for physical exercise

Exclusion Criteria:

  • Complaint of pain that influences or makes the performance of the tests / exercises proposed impossible
  • Congenital or acquired anomalies of upper limbs and lower limbs
  • Presence of musculoskeletal disease or injury that interfere the performance of exercises
  • Changes in pharmacological treatment during the experimental period
  • Release for physical activity suspended during intervention
  • Absence in more than 25% of the exercise sessions

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Traditional Pilates group
This group will perform only exercises based on the traditional Pilates method
Other: Traditional Pilates group
The participants will perform only exercises based on the traditional Pilates method, 2 times a week, for 50 minutes, for 16 weeks.
Experimental: Modified Pilates group
This group will perform exercises based on the Pilates method alternated with active rest periods on treadmill ergometer
Other: Modified Pilates group
The participants will perform exercises based on the Pilates method alternated with active rest periods on treadmill ergometer, 2 times a week, for 50 minutes, for 16 weeks.
No Intervention: Control group
This group will not perform any physical exercise during the trial period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ambulatory blood pressure
Time Frame: Change from Baseline systolic and diastolic Blood Pressure at 16 weeks
Systolic and diastolic blood pressure will be measured by 24-hour Ambulatorial Monitoring Blood Pressure, before and after trial period.
Change from Baseline systolic and diastolic Blood Pressure at 16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical blood pressure
Time Frame: Change from Baseline systolic and diastolic Blood Pressure at 16 weeks
Clinical assessment of systolic and diastolic blood pressure will be measured by an automatic arm blood pressure monitor after 10 minutes of rest, before and after trial period.
Change from Baseline systolic and diastolic Blood Pressure at 16 weeks
Clinical heart rate
Time Frame: Change from Baseline clinical heart rate at 16 weeks
Clinical assessment of heart rate will be measured by a heart rate monitor after 10 minutes of rest, before and after trial period.
Change from Baseline clinical heart rate at 16 weeks
Autonomic heart rate modulation
Time Frame: Change from Baseline autonomic heart rate modulation at 16 weeks
Autonomic heart rate modulation will be assessed by the heart rate variability method using a heart rate monitor, before and after trial period.
Change from Baseline autonomic heart rate modulation at 16 weeks
Ventilatory threshold measured by the cardiopulmonary exercise test
Time Frame: Change from baseline and at 16 weeks
The ventilatory threshold will be measured by the cardiopulmonary exercise test. An ergospirometric exercise test will be performed, consisting of increasing loads, with no pauses between the stages until exhaustion of the volunteer. The examination will be performed in a treadmill with ergospirometric and electrocardiographic analysis.
Change from baseline and at 16 weeks
Analysis of the quality of life
Time Frame: Change from Baseline quality of life at 16 weeks
Quality of life will be analyzed by means of the questionnaire World Health Organization Quality Of Life/Bref (WHOQOL/bref). The questionnaire has twenty-six questions that involve different aspects of daily life and deal with four domains of quality of life: physical, psychological, environmental and social relations. The response is represented by scores ranging from one to five, with the worst score being one and the best score being five. The results of the domains have values between zero and one hundred, with the worst being the closest to zero and the best the closest to one hundred, thus, a value equal to 50 for a given domain can be considered median for that domain.
Change from Baseline quality of life at 16 weeks
Flexibility
Time Frame: Change from Baseline flexibility at 16 weeks
Flexibility will be analyzed by bank of wells test, before and after trial period.
Change from Baseline flexibility at 16 weeks
Strength
Time Frame: Change from Baseline strength at 16 weeks
Strength will be analyzed by hydraulic handgrip dynamometer, before and after trial period.
Change from Baseline strength at 16 weeks
Speed to lift from a sitting position
Time Frame: Change from Baseline speed at16 weeks
Speed to lift from a sitting position will be evaluated by a stopwatch, before and after trial period.
Change from Baseline speed at16 weeks
Speed to lift from a layered position
Time Frame: Change from Baseline speed at 16 weeks
Speed to lift from a layered position will be evaluated by a stopwatch, before and after trial period
Change from Baseline speed at 16 weeks
Speed to put on and tie his shoes
Time Frame: Change from Baseline speed at 16 weeks
Speed to put on and tie his shoes will be evaluated by a stopwatch, before and after trial period.
Change from Baseline speed at 16 weeks
Body weight
Time Frame: Change from Baseline body weight at 16 weeks
Body weight will be measured using a digital scale, before and after trial period.
Change from Baseline body weight at 16 weeks
Height
Time Frame: Change from Baseline at 16 weeks
Height will be measured using a stadiometer.
Change from Baseline at 16 weeks
Body Mass Index
Time Frame: Change from Baseline body mass index at 16 weeks
Will be analyzed as weight divided by height squared.
Change from Baseline body mass index at 16 weeks
Circumference measurements
Time Frame: Change from Baseline circumference measurements at 16 weeks
Will be analyzed the circumference of hip, waist, neck, abdomen, before and after trial period.
Change from Baseline circumference measurements at 16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

João Luiz Q. Durigan

Collaborators

Catholic University of Brasília

Investigators

  • Study Director: João LQ Durigan, PhD, University of Brasilia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 8, 2019

Primary Completion (Actual)

December 20, 2019

Study Completion (Actual)

December 20, 2019

Study Registration Dates

First Submitted

December 18, 2018

First Submitted That Met QC Criteria

December 29, 2018

First Posted (Actual)

January 2, 2019

Study Record Updates

Last Update Posted (Actual)

March 25, 2020

Last Update Submitted That Met QC Criteria

March 24, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAEE: 99221818.9.0000.0029

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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