Clinical trial NCT03791307: Effects of Training Based on the Pilates Method on the Blood Pressure of Hypertensive Women
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: Pilates method
Blood pressure
Autonomic heart rate modulation
Lead sponsor: University of Brasilia
Sponsor class: OTHER
Collaborators: name: Catholic University of Brasília
First posted: 2019-01-02
Enrollment: 60
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Ambulatory blood pressure
timeFrame: Change from Baseline systolic and diastolic Blood Pressure at 16 weeks
Secondary outcomes:
measure: Clinical blood pressure
timeFrame: Change from Baseline systolic and diastolic Blood Pressure at 16 weeks
measure: Clinical heart rate
timeFrame: Change from Baseline clinical heart rate at 16 weeks
measure: Autonomic heart rate modulation
timeFrame: Change from Baseline autonomic heart rate modulation at 16 weeks
measure: Ventilatory threshold measured by the cardiopulmonary exercise test
timeFrame: Change from baseline and at 16 weeks
measure: Analysis of the quality of life
timeFrame: Change from Baseline quality of life at 16 weeks
measure: Flexibility
timeFrame: Change from Baseline flexibility at 16 weeks
measure: Strength
timeFrame: Change from Baseline strength at 16 weeks
measure: Speed to lift from a sitting position
timeFrame: Change from Baseline speed at16 weeks
measure: Speed to lift from a layered position
timeFrame: Change from Baseline speed at 16 weeks
measure: Speed to put on and tie his shoes
timeFrame: Change from Baseline speed at 16 weeks
measure: Body weight
timeFrame: Change from Baseline body weight at 16 weeks
measure: Height
timeFrame: Change from Baseline at 16 weeks
measure: Body Mass Index
timeFrame: Change from Baseline body mass index at 16 weeks
measure: Circumference measurements
timeFrame: Change from Baseline circumference measurements at 16 weeks
Other outcomes:
Locations:
city: Brasília
country: Brazil
facility: University of Brasilia
state: Distrito Federal
Study officials:
affiliation: University of Brasilia
name: João LQ Durigan, PhD
role: STUDY_DIRECTOR
References:
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