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

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ClinicalTrials.gov Identifier: NCT03137849
Recruitment Status : Completed
First Posted : May 3, 2017
Last Update Posted : July 23, 2019
Sponsor:
Information provided by (Responsible Party):
Instituto de Cardiologia do Rio Grande do Sul

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.

Condition or disease Intervention/treatment Phase
Hypertension Postmenopausal Symptoms Other: Yoga Poses Other: Breath Control Other: Stretching exercises Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Outcomes Assessor)
Masking Description: All participants will be told they are attending to a yoga protocol. All outcomes assessments will be taken by blind investigators to the interventions.
Primary Purpose: Health Services Research
Official Title: Autonomic and Cardiovascular Changes of Yoga Poses, Breath Control and Stretching Exercises in Hypertensive Post-Menopause Women: Randomized Controlled Trial
Actual Study Start Date : July 18, 2017
Actual Primary Completion Date : June 30, 2018
Actual Study Completion Date : December 20, 2018

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  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 Outcome Measures :
  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)



Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03137849


Locations
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Brazil
Cardiology Institute of Rio Grande do Sul
Pôrto Alegre, Rio Grande Do Sul, Brazil
Sponsors and Collaborators
Instituto de Cardiologia do Rio Grande do Sul
Investigators
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Study Director: Maria Cláudia Irigoyen, PhD Institute of Cardiology/ University Foundation of Cardiology
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Responsible Party: Instituto de Cardiologia do Rio Grande do Sul
ClinicalTrials.gov Identifier: NCT03137849    
Other Study ID Numbers: 5273/16
First Posted: May 3, 2017    Key Record Dates
Last Update Posted: July 23, 2019
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Instituto de Cardiologia do Rio Grande do Sul:
Yoga
Hypertension
Post-Menopausal Women
Heart Rate Variability
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases