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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Hypertension

Intervention / Treatment
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* Other: Traditional Pilates group
* Other: Modified Pilates group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 59 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ambulatory blood pressure | 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 | 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 | 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 | 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 | 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 | 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 | Flexibility will be analyzed by bank of wells test, before and after trial period. | Change from Baseline flexibility at 16 weeks | 
| Strength | 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 | 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 | 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 | 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 | Body weight will be measured using a digital scale, before and after trial period. | Change from Baseline body weight at 16 weeks | 
| Height | Height will be measured using a stadiometer. | Change from Baseline at 16 weeks | 
| Body Mass Index | Will be analyzed as weight divided by height squared. | Change from Baseline body mass index at 16 weeks | 
| Circumference measurements | Will be analyzed the circumference of hip, waist, neck, abdomen, before and after trial period. | Change from Baseline circumference measurements at 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pilates method, Blood pressure, Autonomic heart rate modulation