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

July 22, 2019 updated by: Instituto de Cardiologia do Rio Grande do Sul

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
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)
30 minutes

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Carotid -femoral pulse wave velocity (Complior)
Time Frame: 10 minutes
Reduction of carotid -femoral pulse wave velocity (m/s)
10 minutes
Maximal Oxygen Uptake by Cardiopulmonary Exercise Test
Time Frame: 45 minutes
Increase Maximal Oxygen Uptake (VO2max ml/kg/min)
45 minutes
Ambulatory Arterial Pressure Monitoring
Time Frame: 24 hours
Decrease Ambulatory Arterial Pressure Monitoring (mmHg)
24 hours
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)
30 minutes along with Finometer
Blood samples laboratorial analysis
Time Frame: 5 minutes
Improved blood sample analysis HDL cholesterol, glucose, creatinine, c-reactive protein (mg/dL)
5 minutes
Flow mediated dilation (FMD) of brachial artery by ultrasound
Time Frame: 20 minutes
Increase Flow Mediated Dilation (FMD) (%)
20 minutes
Fat percentage by Bioimpedance
Time Frame: 5 minutes
Reduction of fat percentage and increase of lean mass (% )
5 minutes
Cognitive function
Time Frame: 40 minutes
Changes in scores of Mini Mental State Examination (0 to 30)
40 minutes
Diaphragm Thickness by ultrasound
Time Frame: 5 minutes
Increase diaphragm thickness (mm)
5 minutes
Intima Media Thickness of carotid artery by ultrasound
Time Frame: 5 minutes
Decrease of intima media thickness (IMT) (mm)
5 minutes
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)
5 minutes along for all blood samples
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)
5 minutes along for all blood samples
Assessment of center of pressure (COP) and balance by baropodometry platform
Time Frame: 5 minutes
Decreased area of COP (cm2)
5 minutes
Sit and reach flexibility test
Time Frame: 5 minutes
Increase flexibility levels (cm)
5 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Instituto de Cardiologia do Rio Grande do Sul

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Maria Cláudia Irigoyen, PhD, Institute of Cardiology/ University Foundation of Cardiology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 18, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 20, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 15, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 28, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 3, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 23, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 22, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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