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

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

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.

Study Overview

• Status: Completed
• Conditions: Hypertension; Postmenopausal Symptoms
• Intervention / Treatment: Other: Yoga Poses; Other: Breath Control; Other: Stretching exercises

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Rio Grande Do Sul
    • Pôrto Alegre, Rio Grande Do Sul, Brazil
      • Cardiology Institute of Rio Grande do Sul

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Yoga Poses + Breath control; 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; 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.; Other: 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.
Active Comparator: Yoga Poses; Twice a week 75 minutes video class of yoga poses routine ( including yoga bandhas/ specific muscles contractions)	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.
Active Comparator: Stretching Exercises + Breath control; Twice a week 75 minutes video class of stretching exercises routine combined with ujjayi pranayama technique as breath control	Other: 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.; Other: 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.
Active Comparator: Stretching Exercises; Twice a week 75 minutes video class of stretching exercises routine	Other: 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Instituto de Cardiologia do Rio Grande do Sul
• Investigators: Study Director: Maria Cláudia Irigoyen, PhD, Institute of Cardiology/ University Foundation of Cardiology

Study record dates

Study Major Dates

• Study Start (Actual): July 18, 2017
• Primary Completion (Actual): June 30, 2018
• Study Completion (Actual): December 20, 2018

Study Registration Dates

• First Submitted: March 15, 2017
• First Submitted That Met QC Criteria: April 28, 2017
• First Posted (Actual): May 3, 2017

Study Record Updates

• Last Update Posted (Actual): July 23, 2019
• Last Update Submitted That Met QC Criteria: July 22, 2019
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: Hypertension; Yoga; Heart Rate Variability; Post-Menopausal Women
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: 5273/16

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No