Clinical trial NCT03137849: Yoga Poses and Breath Control Cardiovascular Changes in Hypertensive Post-Menopause Women
Official title: Autonomic and Cardiovascular Changes of Yoga Poses, Breath Control and Stretching Exercises in Hypertensive Post-Menopause Women: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Postmenopausal Symptoms
Keywords: Yoga
Hypertension
Post-Menopausal Women
Heart Rate Variability
Lead sponsor: Instituto de Cardiologia do Rio Grande do Sul
Sponsor class: OTHER
First posted: 2017-05-03
Enrollment: 50
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Cardiovascular autonomic control by heart rate variability(HRV) and blood pressure variability (BPV) in frequency domain acquired by Finometer
timeFrame: 30 minutes
Secondary outcomes:
measure: Carotid -femoral pulse wave velocity (Complior)
timeFrame: 10 minutes
measure: Maximal Oxygen Uptake by Cardiopulmonary Exercise Test
timeFrame: 45 minutes
measure: Ambulatory Arterial Pressure Monitoring
timeFrame: 24 hours
measure: Respiratory rate and movements of rib cage and abdomen by Pneumotrace respiratory belt
timeFrame: 30 minutes along with Finometer
measure: Blood samples laboratorial analysis
timeFrame: 5 minutes
measure: Flow mediated dilation (FMD) of brachial artery by ultrasound
timeFrame: 20 minutes
measure: Fat percentage by Bioimpedance
timeFrame: 5 minutes
measure: Cognitive function
timeFrame: 40 minutes
measure: Diaphragm Thickness by ultrasound
timeFrame: 5 minutes
measure: Intima Media Thickness of carotid artery by ultrasound
timeFrame: 5 minutes
measure: Blood sample analysis of oxidative stress markers (Spectrophotometry)
timeFrame: 5 minutes along for all blood samples
measure: Blood levels of sample analysis of Inflammatory markers (ELISA)
timeFrame: 5 minutes along for all blood samples
measure: Assessment of center of pressure (COP) and balance by baropodometry platform
timeFrame: 5 minutes
measure: Sit and reach flexibility test
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Pôrto Alegre
country: Brazil
facility: Cardiology Institute of Rio Grande do Sul
state: Rio Grande Do Sul
Study officials:
affiliation: Institute of Cardiology/ University Foundation of Cardiology
name: Maria Cláudia Irigoyen, PhD
role: STUDY_DIRECTOR
References: