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

NCT ID: NCT03137849

Last Updated: 2019-07-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-18

Study Completion Date

2018-12-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hypertension Postmenopausal Symptoms

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Participants Outcome Assessors
All participants will be told they are attending to a yoga protocol. All outcomes assessments will be taken by blind investigators to the interventions.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type ACTIVE_COMPARATOR

Yoga Poses

Intervention Type 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

Intervention Type 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.

Yoga Poses

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

Group Type ACTIVE_COMPARATOR

Yoga Poses

Intervention Type 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.

Stretching Exercises + Breath control

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

Group Type ACTIVE_COMPARATOR

Breath Control

Intervention Type 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

Intervention Type 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.

Stretching Exercises

Twice a week 75 minutes video class of stretching exercises routine

Group Type ACTIVE_COMPARATOR

Stretching exercises

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

45 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Instituto de Cardiologia do Rio Grande do Sul

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Maria Cláudia Irigoyen, PhD

Role: STUDY_DIRECTOR

Institute of Cardiology/ University Foundation of Cardiology

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Cardiology Institute of Rio Grande do Sul

Pôrto Alegre, Rio Grande do Sul, Brazil

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Brazil

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

5273/16

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Yoga in Older Cardiac Patients
NCT06235658 RECRUITING NA