HypertensionYOGININCT03137849
Yoga Poses and Breath Control Cardiovascular Changes in Hypertensive Post-Menopause Women
A study testing Yoga Poses and Stretching exercises in people with Hypertension and Postmenopausal Symptoms, run by Instituto de Cardiologia do Rio Grande do Sul at 1 site in Brazil.
Trial 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.. Read more about this study
- Who is it for?
- Ages 45 to 65 years, women only
- Conditions the study is for
- Hypertension, Postmenopausal Symptoms
- What is being tested?
- Yoga Poses and Stretching exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteBrazil
- Study dates
- 18 Jul 2017to 20 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Use of Betablockers
- recent cardiovascular events or surgery
- renal alterations
- respiratory and/or motor pathologies
- smoking
- BMI>34,9
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Cardiology Institute of Rio Grande do Sul
Pôrto Alegre, Rio Grande do Sul
About this study
Official title: 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.
Read the 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.
- Conditions
- Hypertension, Postmenopausal Symptoms
- Being tested
- Yoga Poses, Breath Control, Stretching exercises
- Keywords
- Yoga, Hypertension, Post-Menopausal Women, Heart Rate Variability
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yoga PosesOther
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 ControlOther
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 exercisesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Yoga Poses + Breath control | Active comparator | 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 Receives: Other: Yoga Poses; Other: Breath Control |
| Yoga Poses | Active comparator | Twice a week 75 minutes video class of yoga poses routine ( including yoga bandhas/ specific muscles contractions) Receives: Other: Yoga Poses |
| Stretching Exercises + Breath control | Active comparator | Twice a week 75 minutes video class of stretching exercises routine combined with ujjayi pranayama technique as breath control Receives: Other: Breath Control; Other: Stretching exercises |
| Stretching Exercises | Active comparator | Twice a week 75 minutes video class of stretching exercises routine Receives: Other: Stretching exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 30 minutes
Secondary outcomes (14)
Carotid -femoral pulse wave velocity (Complior)
Reduction of carotid -femoral pulse wave velocity (m/s)
Measured: 10 minutes
Maximal Oxygen Uptake by Cardiopulmonary Exercise Test
Increase Maximal Oxygen Uptake (VO2max ml/kg/min)
Measured: 45 minutes
Ambulatory Arterial Pressure Monitoring
Decrease Ambulatory Arterial Pressure Monitoring (mmHg)
Measured: 24 hours
Respiratory rate and movements of rib cage and abdomen by Pneumotrace respiratory belt
Reduction of respiratory rate (cycles per minute/ cpm)
Measured: 30 minutes along with Finometer
Blood samples laboratorial analysis
Improved blood sample analysis HDL cholesterol, glucose, creatinine, c-reactive protein (mg/dL)
Measured: 5 minutes
Flow mediated dilation (FMD) of brachial artery by ultrasound
Increase Flow Mediated Dilation (FMD) (%)
Measured: 20 minutes
Fat percentage by Bioimpedance
Reduction of fat percentage and increase of lean mass (% )
Measured: 5 minutes
Cognitive function
Changes in scores of Mini Mental State Examination (0 to 30)
Measured: 40 minutes
Diaphragm Thickness by ultrasound
Increase diaphragm thickness (mm)
Measured: 5 minutes
Intima Media Thickness of carotid artery by ultrasound
Decrease of intima media thickness (IMT) (mm)
Measured: 5 minutes
Blood sample analysis of oxidative stress markers (Spectrophotometry)
Levels of Superoxide Dismutase (SOD) (un/SOD/mg protein)
Measured: 5 minutes along for all blood samples
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)
Measured: 5 minutes along for all blood samples
Assessment of center of pressure (COP) and balance by baropodometry platform
Decreased area of COP (cm2)
Measured: 5 minutes
Sit and reach flexibility test
Increase flexibility levels (cm)
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2017
- Study start18 Jul 2017
- Primary completion30 Jun 2018
- Study completion20 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Cardiologia do Rio Grande do Sul
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria Cláudia Irigoyen, PhD, Study director, Institute of Cardiology/ University Foundation of Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03137849
- Sponsor's protocol ID
- 5273/16
- Acronym
- YOGINI
- Status last verified
- Jul 2017
- First submitted
- 15 Mar 2017
- Last updated
- 23 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autonomic and Cardiovascular Changes of Yoga Poses, Breath Control and Stretching Exercises in Hypertensive Post-Menopause Women: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03137849
- Acronym / sponsor ID
- YOGINI / 5273/16
- Conditions
- Hypertension, Postmenopausal Symptoms
- Keywords
- Yoga, Hypertension, Post-Menopausal Women, Heart Rate Variability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Instituto de Cardiologia do Rio Grande do SulUniversity, hospital or other
- Study start
- 18 Jul 2017 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 20 Dec 2018 (actual)
- First posted
- 3 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Yoga Poses + Breath control | Active comparator | Other: Yoga Poses, Other: Breath ControlTwice 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 |
| Yoga Poses | Active comparator | Other: Yoga PosesTwice a week 75 minutes video class of yoga poses routine ( including yoga bandhas/ specific muscles contractions) |
| Stretching Exercises + Breath control | Active comparator | Other: Breath Control, Other: Stretching exercisesTwice a week 75 minutes video class of stretching exercises routine combined with ujjayi pranayama technique as breath control |
| Stretching Exercises | Active comparator | Other: Stretching exercisesTwice a week 75 minutes video class of stretching exercises routine |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (6 listed)
- Use of Betablockers
- recent cardiovascular events or surgery
- renal alterations
- respiratory and/or motor pathologies
- smoking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Yoga PosesYoga 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 | Yoga Poses, Yoga Poses + Breath control |
| Breath ControlUjjayi 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 + Breath control, Yoga Poses + Breath control |
| Stretching exercisesStretching 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. | Other | Stretching Exercises, Stretching Exercises + Breath control |
Primary outcome
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)
14 secondary outcomes
Carotid -femoral pulse wave velocity (Complior)
Time frame: 10 minutes
Maximal Oxygen Uptake by Cardiopulmonary Exercise Test
Time frame: 45 minutes
Ambulatory Arterial Pressure Monitoring
Time frame: 24 hours
Respiratory rate and movements of rib cage and abdomen by Pneumotrace respiratory belt
Time frame: 30 minutes along with Finometer
Blood samples laboratorial analysis
Time frame: 5 minutes
Flow mediated dilation (FMD) of brachial artery by ultrasound
Time frame: 20 minutes
Fat percentage by Bioimpedance
Time frame: 5 minutes
Cognitive function
Time frame: 40 minutes
Diaphragm Thickness by ultrasound
Time frame: 5 minutes
Intima Media Thickness of carotid artery by ultrasound
Time frame: 5 minutes
Blood sample analysis of oxidative stress markers (Spectrophotometry)
Time frame: 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
Assessment of center of pressure (COP) and balance by baropodometry platform
Time frame: 5 minutes
Sit and reach flexibility test
Time frame: 5 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Cláudia Irigoyen, PhD study director
Institute of Cardiology/ University Foundation of Cardiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yoga Poses and Stretching exercises in people with Hypertension and Postmenopausal Symptoms, run by Instituto de Cardiologia do Rio Grande do Sul at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiovascular autonomic control by heart rate variability(HRV) and blood pressure variability (BPV) in frequency domain acquired by Finometer (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2019.