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Completed

NCT Number: NCT03626792

Effect of Mat Pilates Training on Women After Menopause

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.

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Key information

Conditions

Physical Activity Behavior Blood Pressure Motor Activity

Age range

40 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Jaqueline Pontes Batista

Uberlândia, Minas Gerais, 38400-678, Brazil

About this study

The Pilates program was performed three times a week for 12 weeks. Initially a familiarization was made regarding the principles of the method. All volunteers underwent 24-hour blood pressure assessment using ambulatory blood pressure measurement (ABPM) and venous blood samples were collected from fasting, saliva and questionnaires before and after the Pilates training period.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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;

Exclusion criteria

  • 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.

Treatment and study plan

Hypertensive group

Other

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

Normotensive group

Other

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

Primary outcomes

  1. Blood pressure

    Time frame: Change from Baseline at 12 weeks

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

Secondary outcomes

  1. Ambulatory blood pressure monitoring

    Time frame: Change from Baseline at 12 weeks

    Ambulatory blood pressure monitoring will be monitored during 24 hours using a Dyna+ ABPM device in mmHg.

  2. Kupperman - Blatt Index

    Time frame: Change from Baseline at 12 weeks

    The climacteric symptoms will be evaluated by the following questionnaire Kupperman - Blatt Index. The questionnaire has scores that from 0 to 19 indicate mild symptoms, 20 to 35 moderate and greater than 35 symptoms of severe climacteric.

  3. Cervical Scale

    Time frame: Change from Baseline at 12 weeks

    The climacteric symptoms will be evaluated by the following questionnaire Cervical Scale. The questionnaire does not have scales. Indicates only a high or low score regarding the presence of climacteric symptoms.

  4. Menopause Rating Scale (MRS)

    Time frame: Change from Baseline at 12 weeks

    The climacteric symptoms will be evaluated by the following questionnaire Menopause Rating Scale (MRS). The scores from 0 to 4 of the questionnaire indicate absence of symptoms, as well as from 5 to 8 presence of mild symptoms, 9 to 15 moderate and greater than 16 symptoms of severe climacteric.

  5. Sleep quality

    Time frame: Change from Baseline at 12 weeks

    Sleep quality will be assessed by the Pittsburgh Sleep Quality Index (PSQI).A score of 0 to 4 indicates a good quality of sleep, 5 to 10 quality of bad sleep and greater than 10 the presence of sleep disorder.

Other outcomes

  1. Biochemical analyzes

    Time frame: Change from Baseline at 12 weeks

    From the serum and/or plasma and saliva samples collected and stored, analyzes for lipid profile (total cholesterol and fractions, and triglycerides) and glycemia at rest and for the concentrations of inflammatory cytokines and changes in the activity of the Antioxidant system.

Sponsors and collaborators

Lead sponsor

Federal University of Uberlandia

Other

Registry information

Official study title

Effect of Mat Pilates Training on Climacteric Symptoms and Physiological Changes in Women After Menopause

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Aug 13, 2018
Registry last updated
Mar 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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