NCT03626792

Brief Summary

This project aims to verify the chronic effect of Mat Pilates exercise on climacteric symptoms, ambulatory blood pressure responses, lipid and glucose profile and pro and anti-inflammatory and antioxidant markers in postmenopausal normotensive and hypertensive women. All volunteers received the same intervention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 24, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

August 5, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 28, 2018

Completed
5 months until next milestone

First Posted

Study publicly available on registry

August 13, 2018

Completed
Last Updated

March 22, 2022

Status Verified

March 1, 2022

Enrollment Period

5 months

First QC Date

April 24, 2017

Last Update Submit

March 7, 2022

Conditions

Keywords

PilatesBlood PressurePostmenopausal women

Outcome Measures

Primary Outcomes (1)

  • Blood pressure

    Resting diastolic and systolic blood pressures will be monitored by Microlife® BP 3BT0A automatic monitor in mmHg.

    Change from Baseline at 12 weeks

Secondary Outcomes (5)

  • Ambulatory blood pressure monitoring

    Change from Baseline at 12 weeks

  • Kupperman - Blatt Index

    Change from Baseline at 12 weeks

  • Cervical Scale

    Change from Baseline at 12 weeks

  • Menopause Rating Scale (MRS)

    Change from Baseline at 12 weeks

  • Sleep quality

    Change from Baseline at 12 weeks

Other Outcomes (1)

  • Biochemical analyzes

    Change from Baseline at 12 weeks

Study Arms (2)

Hypertensive group

OTHER

The Mat Pilates session was held lasting 50 minutes of exercises with the first 5 minutes heating and in each exercise performing 10 repetitions with 45 seconds of rest between one exercise and another. For practice, are used only mats, and alternative devices such as the Swiss ball and the flexible ring, as well as body weight and the force of gravity as resistance factors and Borg's subjective perception of effort scale for intensity parameters. The 20 exercises were chosen through the classic exercises thus classified by the creator of the Joseph Pilates method.During the sessions, volunteers were instructed on correct breathing without performing the valsalva maneuver.

Other: Hypertensive group

Normotensive group

OTHER

The Mat Pilates session was held lasting 50 minutes of exercises with the first 5 minutes heating and in each exercise performing 10 repetitions with 45 seconds of rest between one exercise and another. For practice, are used only mats, and alternative devices such as the Swiss ball and the flexible ring, as well as body weight and the force of gravity as resistance factors and Borg's subjective perception of effort scale for intensity parameters. The 20 exercises were chosen through the classic exercises thus classified by the creator of the Joseph Pilates method.During the sessions, volunteers were instructed on correct breathing without performing the valsalva maneuver.

Other: Normotensive group

Interventions

Pilates 12-week training on the ground, often 3 times a week for 50 minutes of prescribed method exercises.

Hypertensive group

Pilates 12-week training on the ground, often 3 times a week for 50 minutes of prescribed method exercises.

Normotensive group

Eligibility Criteria

Age40 Years - 70 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women between the ages of 40 and 70;
  • Be post menopausal (amenorrhea for at least 12 months);
  • Medical release to perform physical activities.
  • Do not present physical problems or cardiovascular complications that prevent the performance of physical exercises;

You may not qualify if:

  • To present a history of stroke or acute myocardial infarction;
  • Smoking;
  • Diagnosis of Diabetes Mellitus.
  • Present renal pathologies.
  • Use medications that interfere with lipid metabolism;
  • Use of antihypertensive drugs (except for the hypertensive group);
  • Use hormone replacement therapies;
  • Present gastrointestinal conditions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jaqueline Pontes Batista

Uberlândia, Minas Gerais, 38400-678, Brazil

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Guilherme M Puga, Phd

    Federal University of Uberlandia

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: * Group 1 - Hypertensive: Composed of hypertensive women who participated in a training program with Pilates exercises in the soil associated to the daily antihypertensive of each one. * Group 2 - Normotensives: Composed of normotensive women who participated in a training program with solo Pilates exercises without antihypertensive presence. Both groups underwent 12 weeks of Pilates training.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 24, 2017

First Posted

August 13, 2018

Study Start

August 5, 2017

Primary Completion

December 20, 2017

Study Completion

March 28, 2018

Last Updated

March 22, 2022

Record last verified: 2022-03

Locations