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Completed

NCT Number: NCT03791307

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

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

30 year–59 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Brasilia

Brasília, Federal District, 72220-900, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Traditional Pilates group

Other

The participants will perform only exercises based on the traditional Pilates method, 2 times a week, for 50 minutes, for 16 weeks.

Modified Pilates group

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. Flexibility

    Time frame: Change from Baseline flexibility at 16 weeks

    Flexibility will be analyzed by bank of wells test, before and after trial period.

  7. Strength

    Time frame: Change from Baseline strength at 16 weeks

    Strength will be analyzed by hydraulic handgrip dynamometer, before and after trial period.

  8. 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.

  9. 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

  10. 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.

  11. 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.

  12. Height

    Time frame: Change from Baseline at 16 weeks

    Height will be measured using a stadiometer.

  13. Body Mass Index

    Time frame: Change from Baseline body mass index at 16 weeks

    Will be analyzed as weight divided by height squared.

  14. 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.

Sponsors and collaborators

Lead sponsor

João Luiz Q. Durigan

Other

Collaborators

  • Catholic University of Brasília

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jan 2, 2019
Registry last updated
Mar 25, 2020

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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