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Completed

NCT Number: NCT03137849

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

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Postmenopausal Symptoms Vascular Diseases

Age range

45 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Cardiology Institute of Rio Grande do Sul

Pôrto Alegre, Rio Grande do Sul, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Yoga Poses

Other

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

Other

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

Other

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.

Primary outcomes

  1. Cardiovascular autonomic control by heart rate variability(HRV) and blood pressure variability (BPV) in frequency domain acquired by Finometer

    Time frame: 30 minutes

    Sympathovagal balance HRV (ratio of low frequency (LF in ms2) and high frequency (HF in ms2) components of HRV = LF/HF)

Secondary outcomes

  1. Carotid -femoral pulse wave velocity (Complior)

    Time frame: 10 minutes

    Reduction of carotid -femoral pulse wave velocity (m/s)

  2. Maximal Oxygen Uptake by Cardiopulmonary Exercise Test

    Time frame: 45 minutes

    Increase Maximal Oxygen Uptake (VO2max ml/kg/min)

  3. Ambulatory Arterial Pressure Monitoring

    Time frame: 24 hours

    Decrease Ambulatory Arterial Pressure Monitoring (mmHg)

  4. Respiratory rate and movements of rib cage and abdomen by Pneumotrace respiratory belt

    Time frame: 30 minutes along with Finometer

    Reduction of respiratory rate (cycles per minute/ cpm)

  5. Blood samples laboratorial analysis

    Time frame: 5 minutes

    Improved blood sample analysis HDL cholesterol, glucose, creatinine, c-reactive protein (mg/dL)

  6. Flow mediated dilation (FMD) of brachial artery by ultrasound

    Time frame: 20 minutes

    Increase Flow Mediated Dilation (FMD) (%)

  7. Fat percentage by Bioimpedance

    Time frame: 5 minutes

    Reduction of fat percentage and increase of lean mass (% )

  8. Cognitive function

    Time frame: 40 minutes

    Changes in scores of Mini Mental State Examination (0 to 30)

  9. Diaphragm Thickness by ultrasound

    Time frame: 5 minutes

    Increase diaphragm thickness (mm)

  10. Intima Media Thickness of carotid artery by ultrasound

    Time frame: 5 minutes

    Decrease of intima media thickness (IMT) (mm)

  11. Blood sample analysis of oxidative stress markers (Spectrophotometry)

    Time frame: 5 minutes along for all blood samples

    Levels of Superoxide Dismutase (SOD) (un/SOD/mg protein)

  12. Blood levels of sample analysis of Inflammatory markers (ELISA)

    Time frame: 5 minutes along for all blood samples

    Levels of Interleukin(IL) IL 1, IL 6, IL 10 (pg/ml)Tumor Necrosis Factor (TNF) alpha (pg/ml)

  13. Assessment of center of pressure (COP) and balance by baropodometry platform

    Time frame: 5 minutes

    Decreased area of COP (cm2)

  14. Sit and reach flexibility test

    Time frame: 5 minutes

    Increase flexibility levels (cm)

Sponsors and collaborators

Lead sponsor

Instituto de Cardiologia do Rio Grande do Sul

Other

Registry information

Official study title

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

Acronym: YOGINI

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
May 3, 2017
Registry last updated
Jul 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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