Yoga Poses and Breath Control Cardiovascular Changes in Hypertensive Post-Menopause Women

Study Overview
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Brief Summary
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Autonomic and endothelial imbalance in post menopause women raise the need to manage cardiovascular risk. Yoga poses and breathing control present controversial results on prevention and treatment of hypertension.. The aim of this study is to compare the effect of 12 week intervention based on yoga poses and their muscle contractions known as bandhas (pelvic floor, core and throat/neck) and ujjayi pranayama (victorious breath) on autonomic modulation, endothelial function, arterial stiffness, aerobic capacity and cognitive function of hypertensive post-menopausal women.

Detailed Description
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Abstract: Increased hypertension prevalence in post-menopausal women, along with cardiovascular damages such as autonomic and endothelial imbalance raise the need to include non-pharmacological interventions, such as yoga in the management of cardiovascular risk. Yoga practices are composed by several variations of techniques including physical postures (yoga poses and specific muscles contractions), breathing control (pranayamas), relaxation and meditation, beside others.The effects of each of these compounds has not been elucidated up to date and can be considered confounding effects for commonly named yoga programs. Existing yoga based data are controversial about its effect on prevention and treatment of hypertension and point to poor methodological standards of most studies. Considering the effects of comparable interventions such as slow breathing on improving autonomic modulation, resistive and isometric exercise on endothelial function, and associations of flexibility with arterial stiffness, it´s licit to search for specific effects of yoga compounds. Thus, the aim of this study is to compare the effect of 12 week intervention based on yoga poses including their muscle contractions known as bandhas (pelvic floor, core and throat/neck), ujjayi pranayama (victorious breath) and stretching/ flexibility on autonomic modulation, endothelial function, arterial stiffness, aerobic capacity and cognitive function of hypertensive post-menopausal women.

Official Title
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Autonomic and Cardiovascular Changes of Yoga Poses, Breath Control and Stretching Exercises in Hypertensive Post-Menopause Women: Randomized Controlled Trial

Conditions
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Hypertension, Postmenopausal Symptoms

Intervention / Treatment
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* Other: Yoga Poses
* Other: Breath Control
* Other: Stretching exercises


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: FSH>35mui/ml minimum 12 months amenorrhea sedentary life style (less than 150 minutes per week of exercise) never been in yoga -practicing (self declaration) Blood pressure > 140/90 or in continuous use of medication (diuretics,Ca+ channel inhibitors, ACE inhibitors) Exclusion Criteria: Use of Betablockers recent cardiovascular events or surgery renal alterations respiratory and/or motor pathologies smoking BMI>34,9

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 65 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: Health Services Research
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Yoga Poses + Breath control<br>Twice a week 75 minutes video class of yoga poses routine ( including yoga bandhas with specific muscles contractions) combined with ujjayi pranayama technique as breath control | Other: Yoga Poses<br>* Yoga poses routine including specific muscles contractions known as bandhas (pelvic floor, core and throat/neck contraction) within each pose, which are advised to be done with steadiness and comfort.<br>Other: Breath Control<br>* Ujjayi pranayama (Victorious breath) Inhalation and exhalation are both done through the nose. The ocean sound is created by moving the glottis as air passes in and out. As the throat passage is narrowed so, too, is the airway, the passage of air through which creates a rushing sound. The length and speed of the breath is controlled by the diaphragm, the Strengthening of which is, in part, the purpose of ujjayi. The inhalations and exhalations are equal in duration.<br>|
| Active Comparator: Yoga Poses<br>Twice a week 75 minutes video class of yoga poses routine ( including yoga bandhas/ specific muscles contractions) | Other: Yoga Poses<br>* Yoga poses routine including specific muscles contractions known as bandhas (pelvic floor, core and throat/neck contraction) within each pose, which are advised to be done with steadiness and comfort.<br>|
| Active Comparator: Stretching Exercises + Breath control<br>Twice a week 75 minutes video class of stretching exercises routine combined with ujjayi pranayama technique as breath control | Other: Breath Control<br>* Ujjayi pranayama (Victorious breath) Inhalation and exhalation are both done through the nose. The ocean sound is created by moving the glottis as air passes in and out. As the throat passage is narrowed so, too, is the airway, the passage of air through which creates a rushing sound. The length and speed of the breath is controlled by the diaphragm, the Strengthening of which is, in part, the purpose of ujjayi. The inhalations and exhalations are equal in duration.<br>Other: Stretching exercises<br>* Stretching exercises routine based on dynamic and static exercises excluding those similar to yoga poses. This routine works on great range of motion of all body joints and main muscles groups/ chains.<br>|
| Active Comparator: Stretching Exercises<br>Twice a week 75 minutes video class of stretching exercises routine | Other: Stretching exercises<br>* Stretching exercises routine based on dynamic and static exercises excluding those similar to yoga poses. This routine works on great range of motion of all body joints and main muscles groups/ chains.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular autonomic control by heart rate variability(HRV) and blood pressure variability (BPV) in frequency domain acquired by Finometer | Sympathovagal balance HRV (ratio of low frequency (LF in ms2) and high frequency (HF in ms2) components of HRV = LF/HF) | 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Carotid -femoral pulse wave velocity (Complior) | Reduction of carotid -femoral pulse wave velocity (m/s) | 10 minutes | 
| Maximal Oxygen Uptake by Cardiopulmonary Exercise Test | Increase Maximal Oxygen Uptake (VO2max ml/kg/min) | 45 minutes | 
| Ambulatory Arterial Pressure Monitoring | Decrease Ambulatory Arterial Pressure Monitoring (mmHg) | 24 hours | 
| Respiratory rate and movements of rib cage and abdomen by Pneumotrace respiratory belt | Reduction of respiratory rate (cycles per minute/ cpm) | 30 minutes along with Finometer | 
| Blood samples laboratorial analysis | Improved blood sample analysis HDL cholesterol, glucose, creatinine, c-reactive protein (mg/dL) | 5 minutes | 
| Flow mediated dilation (FMD) of brachial artery by ultrasound | Increase Flow Mediated Dilation (FMD) (%) | 20 minutes | 
| Fat percentage by Bioimpedance | Reduction of fat percentage and increase of lean mass (% ) | 5 minutes | 
| Cognitive function | Changes in scores of Mini Mental State Examination (0 to 30) | 40 minutes | 
| Diaphragm Thickness by ultrasound | Increase diaphragm thickness (mm) | 5 minutes | 
| Intima Media Thickness of carotid artery by ultrasound | Decrease of intima media thickness (IMT) (mm) | 5 minutes | 
| Blood sample analysis of oxidative stress markers (Spectrophotometry) | Levels of Superoxide Dismutase (SOD) (un/SOD/mg protein) | 5 minutes along for all blood samples | 
| Blood levels of sample analysis of Inflammatory markers (ELISA) | Levels of Interleukin(IL) IL 1, IL 6, IL 10 (pg/ml)Tumor Necrosis Factor (TNF) alpha (pg/ml) | 5 minutes along for all blood samples | 
| Assessment of center of pressure (COP) and balance by baropodometry platform | Decreased area of COP (cm2) | 5 minutes | 
| Sit and reach flexibility test | Increase flexibility levels (cm) | 5 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Yoga, Hypertension, Post-Menopausal Women, Heart Rate Variability