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

Hypertension Clinical Trial

— YOGINI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03137849
• Other study ID #: 5273/16
• Status: Completed
• Phase: N/A
• Start date: July 18, 2017
• Est. completion date: December 20, 2018

Study information

• Verified date: July 2017
• Source: Instituto de Cardiologia do Rio Grande do Sul
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 20, 2018
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertension
• Postmenopausal Symptoms

Intervention

Other:
• Yoga Poses
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.
• Breath Control
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.
• Stretching exercises
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.

Locations

Country	Name	City	State
Brazil	Cardiology Institute of Rio Grande do Sul	Pôrto Alegre	Rio Grande Do Sul

Sponsors (1)

Lead Sponsor	Collaborator
Instituto de Cardiologia do Rio Grande do Sul

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Carotid -femoral pulse wave velocity (Complior)	Reduction of carotid -femoral pulse wave velocity (m/s)	10 minutes
Secondary	Maximal Oxygen Uptake by Cardiopulmonary Exercise Test	Increase Maximal Oxygen Uptake (VO2max ml/kg/min)	45 minutes
Secondary	Ambulatory Arterial Pressure Monitoring	Decrease Ambulatory Arterial Pressure Monitoring (mmHg)	24 hours
Secondary	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
Secondary	Blood samples laboratorial analysis	Improved blood sample analysis HDL cholesterol, glucose, creatinine, c-reactive protein (mg/dL)	5 minutes
Secondary	Flow mediated dilation (FMD) of brachial artery by ultrasound	Increase Flow Mediated Dilation (FMD) (%)	20 minutes
Secondary	Fat percentage by Bioimpedance	Reduction of fat percentage and increase of lean mass (% )	5 minutes
Secondary	Cognitive function	Changes in scores of Mini Mental State Examination (0 to 30)	40 minutes
Secondary	Diaphragm Thickness by ultrasound	Increase diaphragm thickness (mm)	5 minutes
Secondary	Intima Media Thickness of carotid artery by ultrasound	Decrease of intima media thickness (IMT) (mm)	5 minutes
Secondary	Blood sample analysis of oxidative stress markers (Spectrophotometry)	Levels of Superoxide Dismutase (SOD) (un/SOD/mg protein)	5 minutes along for all blood samples
Secondary	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
Secondary	Assessment of center of pressure (COP) and balance by baropodometry platform	Decreased area of COP (cm2)	5 minutes
Secondary	Sit and reach flexibility test	Increase flexibility levels (cm)	5 minutes