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

Primary Purpose

Hypertension, Postmenopausal Symptoms

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Yoga Poses
Breath Control
Stretching exercises
Sponsored by
Instituto de Cardiologia do Rio Grande do Sul
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Hypertension focused on measuring Yoga, Hypertension, Post-Menopausal Women, Heart Rate Variability

Eligibility Criteria

45 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Cardiology Institute of Rio Grande do Sul

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Yoga Poses + Breath control

Yoga Poses

Stretching Exercises + Breath control

Stretching Exercises

Arm Description

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

Twice a week 75 minutes video class of yoga poses routine ( including yoga bandhas/ specific muscles contractions)

Twice a week 75 minutes video class of stretching exercises routine combined with ujjayi pranayama technique as breath control

Twice a week 75 minutes video class of stretching exercises routine

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Carotid -femoral pulse wave velocity (Complior)
Reduction of carotid -femoral pulse wave velocity (m/s)
Maximal Oxygen Uptake by Cardiopulmonary Exercise Test
Increase Maximal Oxygen Uptake (VO2max ml/kg/min)
Ambulatory Arterial Pressure Monitoring
Decrease Ambulatory Arterial Pressure Monitoring (mmHg)
Respiratory rate and movements of rib cage and abdomen by Pneumotrace respiratory belt
Reduction of respiratory rate (cycles per minute/ cpm)
Blood samples laboratorial analysis
Improved blood sample analysis HDL cholesterol, glucose, creatinine, c-reactive protein (mg/dL)
Flow mediated dilation (FMD) of brachial artery by ultrasound
Increase Flow Mediated Dilation (FMD) (%)
Fat percentage by Bioimpedance
Reduction of fat percentage and increase of lean mass (% )
Cognitive function
Changes in scores of Mini Mental State Examination (0 to 30)
Diaphragm Thickness by ultrasound
Increase diaphragm thickness (mm)
Intima Media Thickness of carotid artery by ultrasound
Decrease of intima media thickness (IMT) (mm)
Blood sample analysis of oxidative stress markers (Spectrophotometry)
Levels of Superoxide Dismutase (SOD) (un/SOD/mg protein)
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)
Assessment of center of pressure (COP) and balance by baropodometry platform
Decreased area of COP (cm2)
Sit and reach flexibility test
Increase flexibility levels (cm)

Full Information

First Posted
March 15, 2017
Last Updated
July 22, 2019
Sponsor
Instituto de Cardiologia do Rio Grande do Sul
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1. Study Identification

Unique Protocol Identification Number
NCT03137849
Brief Title
Yoga Poses and Breath Control Cardiovascular Changes in Hypertensive Post-Menopause Women
Acronym
YOGINI
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

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
July 18, 2017 (Actual)
Primary Completion Date
June 30, 2018 (Actual)
Study Completion Date
December 20, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto de Cardiologia do Rio Grande do Sul

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Postmenopausal Symptoms
Keywords
Yoga, Hypertension, Post-Menopausal Women, Heart Rate Variability

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantOutcomes 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.
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Yoga Poses + Breath control
Arm Type
Active Comparator
Arm Description
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
Arm Title
Yoga Poses
Arm Type
Active Comparator
Arm Description
Twice a week 75 minutes video class of yoga poses routine ( including yoga bandhas/ specific muscles contractions)
Arm Title
Stretching Exercises + Breath control
Arm Type
Active Comparator
Arm Description
Twice a week 75 minutes video class of stretching exercises routine combined with ujjayi pranayama technique as breath control
Arm Title
Stretching Exercises
Arm Type
Active Comparator
Arm Description
Twice a week 75 minutes video class of stretching exercises routine
Intervention Type
Other
Intervention Name(s)
Yoga Poses
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Breath Control
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Stretching exercises
Intervention Description
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 Measure Information:
Title
Cardiovascular autonomic control by heart rate variability(HRV) and blood pressure variability (BPV) in frequency domain acquired by Finometer
Description
Sympathovagal balance HRV (ratio of low frequency (LF in ms2) and high frequency (HF in ms2) components of HRV = LF/HF)
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
Carotid -femoral pulse wave velocity (Complior)
Description
Reduction of carotid -femoral pulse wave velocity (m/s)
Time Frame
10 minutes
Title
Maximal Oxygen Uptake by Cardiopulmonary Exercise Test
Description
Increase Maximal Oxygen Uptake (VO2max ml/kg/min)
Time Frame
45 minutes
Title
Ambulatory Arterial Pressure Monitoring
Description
Decrease Ambulatory Arterial Pressure Monitoring (mmHg)
Time Frame
24 hours
Title
Respiratory rate and movements of rib cage and abdomen by Pneumotrace respiratory belt
Description
Reduction of respiratory rate (cycles per minute/ cpm)
Time Frame
30 minutes along with Finometer
Title
Blood samples laboratorial analysis
Description
Improved blood sample analysis HDL cholesterol, glucose, creatinine, c-reactive protein (mg/dL)
Time Frame
5 minutes
Title
Flow mediated dilation (FMD) of brachial artery by ultrasound
Description
Increase Flow Mediated Dilation (FMD) (%)
Time Frame
20 minutes
Title
Fat percentage by Bioimpedance
Description
Reduction of fat percentage and increase of lean mass (% )
Time Frame
5 minutes
Title
Cognitive function
Description
Changes in scores of Mini Mental State Examination (0 to 30)
Time Frame
40 minutes
Title
Diaphragm Thickness by ultrasound
Description
Increase diaphragm thickness (mm)
Time Frame
5 minutes
Title
Intima Media Thickness of carotid artery by ultrasound
Description
Decrease of intima media thickness (IMT) (mm)
Time Frame
5 minutes
Title
Blood sample analysis of oxidative stress markers (Spectrophotometry)
Description
Levels of Superoxide Dismutase (SOD) (un/SOD/mg protein)
Time Frame
5 minutes along for all blood samples
Title
Blood levels of sample analysis of Inflammatory markers (ELISA)
Description
Levels of Interleukin(IL) IL 1, IL 6, IL 10 (pg/ml)Tumor Necrosis Factor (TNF) alpha (pg/ml)
Time Frame
5 minutes along for all blood samples
Title
Assessment of center of pressure (COP) and balance by baropodometry platform
Description
Decreased area of COP (cm2)
Time Frame
5 minutes
Title
Sit and reach flexibility test
Description
Increase flexibility levels (cm)
Time Frame
5 minutes

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Cláudia Irigoyen, PhD
Organizational Affiliation
Institute of Cardiology/ University Foundation of Cardiology
Official's Role
Study Director
Facility Information:
Facility Name
Cardiology Institute of Rio Grande do Sul
City
Pôrto Alegre
State/Province
Rio Grande Do Sul
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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