HypertensionHYNCT07125313
Effect of Yoga Training on Cardiovascular and Mental Health Parameters in Hypertensive Patients
A study testing YOGA in people with Hypertension, run by Universidade Federal de Santa Catarina at 1 site in Brazil.
Trial summary
The objective of this study will be to analyze the effect of 16 weeks of Yoga training on cardiovascular, autonomic, mental health, and cognitive parameters in hypertensive individuals. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- YOGA
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteBrazil
- Study dates
- 11 Aug 2025to 20 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults or elderly individuals
- >= 40 years
- Both sexes
- Diagnosis of hypertension controlled by up to three medications
- Who do not present high cardiovascular risk
- Who have not engaged in a physical exercise program in the six months prior to the start of the study will participate in the study.
Who cannot join
- Adherence of less than 75% of training sessions
- Diagnosis of other diseases during the study
- Adherence to another physical exercise program
- Change in the class and/or dose of antihypertensive medication during the study
- Worsening of the disease (resting systolic blood pressure (BP) > 180 mmHg).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Universidade Federal de Santa Catarina
Florianópolis, Santa Catarina, 88040-900
Aline Gerage, PhD, 4899934799, alinegerage@yahoo.com.br
About this study
Official title: Effect of Yoga Training on Cardiovascular, Autonomic, Mental Health and Cognitive Parameters in Hypertensive Patients: a Randomized Controlled Clinical Trial (Hypertension and Yoga Study)
The objective of this study will be to analyze the effect of 16 weeks of Yoga training on cardiovascular, autonomic, mental health, and cognitive parameters in hypertensive individuals. This is a randomized, controlled clinical trial to be conducted with adults and elderly (40 years or older), of both sexes, diagnosed with High Blood Pressure (HBP), who will be randomized into two groups: Yoga Group (YG) and Control Group (CG). The YG will undergo a Yoga training program involving breathing techniques, mobility, physical postures, relaxation, and meditation for 16 weeks. In the first eight weeks (phase 1), three supervised weekly sessions will be held. In the last eight weeks of the study (phase 2), the training will consist of three supervised weekly sessions and the delivery of an asynchronous video lesson, with the weekly frequency then increasing (from three to four sessions per week). The video lesson will be available on a digital platform. Before, after eight weeks, and after 16 weeks, cardiovascular, autonomic, mental and cognitive health parameters will be assessed. Furthermore, the biomarkers Brain-Derived Neurotrophic Factor (BDNF), serotonin, and nitric oxide will be analyzed at different assessment times of the study, as well as biochemical profile tests (glucose, total cholesterol, among others), functional capacity tests, and body composition. This project is expected to contribute to the literature by better elucidating the effects of Yoga on the cardiovascular, mental, and cognitive health of hypertensive individuals. The SPSS (21.0) statistical package will be used for data analysis. After confirming the appropriate assumptions, generalized estimating equations will be used, followed by the Bonferroni post hoc test, with a significance level of 5%.
- Conditions
- Hypertension
- Being tested
- YOGA, Control
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YOGABehavioural
The participants randomized to the yoga group will perform 16 weeks of yoga training, three times/week for 60 minutes.
ControlBehavioural
Usual care
| Study group | Role | What they receive |
|---|---|---|
| YOGA | Experimental | The GY will receive an intervention involving Yoga Training (TY), which will be divided into two phases: Phase 1 (first eight weeks), which will be supervised, with three weekly sessions lasting 60 minutes, and Phase 2 (the following eight weeks), which will consist of three supervised sessions per week and the delivery of an asynchronous video lesson via a digital platform, with an incremental session of one session per week. Classes will also be 60 minutes long. The supervised sessions will take place at the UFSC CDS rehabilitation center. TY sessions will follow the following structure: breathing techniques (Pranayama), warm-up (Pavana Muktasana), physical postures in standing, sitting, and lying positions (Asanas), and relaxation (Yoganidrá). The postures will be prescribed by holding time in seconds (30 to 40 seconds), number of sets, and rest between sets. Each session will include beginner, intermediate, and advanced postures. Receives: Behavioral: YOGA |
| CONTROL | Other | The CG will not receive any intervention during the study and, like the GY subjects, will be instructed not to change their routines. Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Pressure
Clinical BP (Systolic and Diastolic) will be measured using an oscillometric device (Omron HEM 742) (OMRON Healthcare, Kyoto, Japan), according to current recommendations, while ambulatory BP will be assessed over 24 hours using a DynaMAPA device (Cardios), both in accordance with current recommendations (FEITOSA et al., 2024).
Measured: Baseline, 8 and 16 weeks
Secondary outcomes (8)
Quality of life
Quality of life will be assessed using the EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) (EUROQOL, 2025; VAN ROTTERDAM, HENSLEY, HAZELTON, 2021). This questionnaire was introduced by the EuroQol Group in 2009. This questionnaire assessed quality of life and health perception, consisting of a page with an objective questionnaire and another page with a visual analog scale. The objective questionnaire is divided into five aspects: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each aspect has five levels ranging from "no problem" (1) to "extreme problem" (5), thus, higher scores denote a worse quality of life. The scale allows participants to record their overall health perception on a vertical scale, from 0 (worst health) to 100 (best health) (BAGATTINI, 2015).
Measured: Baseline, 8 and 16 weeks
Cognitive function
Cognitive function will be assessed using the Montreal Cognitive Assessment (MoCA) questionnaire, which comprises eight domains. The maximum score is 30 points, corresponding to the best cognitive ability (HOBSON, 2015).
Measured: Baseline, 8 and 16 weeks
Sleep Quality
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI-BR) (BERTOLAZI et al., 2011; BUYSSE, 1989). It consists of a questionnaire composed of 19 self-administered questions, followed by five questions to be answered by the bed partner, if available. This questionnaire is composed of seven domains: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction (BERTOLAZI et al., 2011). Minimum: 0 points → excellent sleep and Maximum: 21 points → very poor sleep.
Measured: Baseline, 8 and 16 weeks
Depressive Symptoms
Depressive symptoms will be assessed using the Patient Health Questionnaire-9 (PHQ-9) (APA, 2000; SANTOS et al., 2013), containing nine questions that assess the presence of symptoms of a major depressive episode, described in the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV): depressed mood, anhedonia, problems with sleep, fatigue or lack of energy, changes in appetite or weight, feelings of guilt or worthlessness, trouble concentrating, feeling sluggish or restless, and suicidal thoughts (APA, 2000). The PHQ9 assesses the frequency of symptoms in the past two weeks, assessed on a scale with the possible responses of "none of the time," "several days," "more than half the days," and "almost every day" (SANTOS et al., 2013). Values can range from 0 to 27, with higher values indicating a greater presence of depressive symptoms.
Measured: Baseline, 8 and 16 weeks
Stress
Perceived stress will be assessed using the Perceived Stress Scale-10 (PSS-10) (SIQUEIRA REIS, FERREIRA HINO \& RODRIGUEZ AÑEZ, 2010). It is an instrument that assesses the level of stress perceived by the person in recent weeks, that is, how they interpret and feel life situations as stressful. There are 10 items, each with answers from 0 to 4 points. Minimum possible: 0 points → no perceived stress and Maximum possible: 40 points → very high perceived stress. Higher values = greater perception of stress
Measured: Baseline, 8 and 16 weeks
Attention and inhibitory response capacity
The Stroop Test will assess attention and inhibitory response capacity, calculating response time and accuracy. Better results are associated with shorter response times and fewer errors. By comparing congruent and incongruent conditions, cognitive interference and inhibitory control will be assessed (STROOP, 1935). Shorter reaction time and fewer errors → better cognitive performance and Longer reaction time and more errors → worse performance (may reflect attention difficulties, but not necessarily anxiety). There is no single universal minimum and maximum value.
Measured: Baseline, 8 and 16 weeks
Health related quality of life
The Short Form Health Survey - 36 items (SF-36) It is a questionnaire that measures health-related quality of life in a broad way, covering physical, emotional and social aspects. Assesses 8 domains: Functional capacity, Physical aspects, Pain, General health, Vitality, Social aspects, Emotional aspects and Mental health. The SF-36 has a scoring system in which higher values indicate better, not worse, quality of life. Score for each domain: ranges from 0 to 100 0 → worst possible state 100 → best possible state Summary scores (physical and mental components) are also typically converted to this 0-100 scale (Ware; Sherboune, 1992).
Measured: Baseline, 8 and 16 weeks
Anxiety
Hospital Anxiety and Depression Scale (HAD) is an instrument used to assess symptoms of anxiety and depression in patients. HAD-A → Anxiety Subscale (7 items) and HAD-D → Depression Subscale (7 items). Each item is scored from 0 to 3. Subscale score: Minimum: 0 points (no symptoms) and Maximum: 21 points (very severe symptoms). Higher values indicate more symptoms of anxiety or depression, depending on the subscale.
Measured: Baseline, 8 and 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2025
- Study start11 Aug 2025
- Primary completion20 Dec 2026 (estimated)
- Study completion20 Dec 2026 (estimated)
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Santa Catarina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aline Mendes Gerage, Universidade Federal de Santa Catarina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07125313
- Sponsor's protocol ID
- HY STUDY
- Acronym
- HY
- Status last verified
- Jun 2026
- First submitted
- 23 Jul 2025
- Last updated
- 22 Jun 2026
- Results posted
- No
- 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 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Yoga Training on Cardiovascular, Autonomic, Mental Health and Cognitive Parameters in Hypertensive Patients: a Randomized Controlled Clinical Trial (Hypertension and Yoga Study)
- ClinicalTrials.gov ID
- NCT07125313
- Acronym / sponsor ID
- HY / HY STUDY
- Conditions
- Hypertension
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Universidade Federal de Santa CatarinaUniversity, hospital or other
- Study start
- 11 Aug 2025 (actual)
- Primary completion
- 20 Dec 2026 (estimated)
- Study completion
- 20 Dec 2026 (estimated)
- First posted
- 15 Aug 2025 (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.
The objective of this study will be to analyze the effect of 16 weeks of Yoga training on cardiovascular, autonomic, mental health, and cognitive parameters in hypertensive individuals. This is a randomized, controlled clinical trial to be conducted with adults and elderly (40 years or older), of both sexes, diagnosed with High Blood Pressure (HBP), who will be randomized into two groups: Yoga Group (YG) and Control Group (CG). The YG will undergo a Yoga training program involving breathing techniques, mobility, physical postures, relaxation, and meditation for 16 weeks. In the first eight weeks (phase 1), three supervised weekly sessions will be held. In the last eight weeks of the study (phase 2), the training will consist of three supervised weekly sessions and the delivery of an asynchronous video lesson, with the weekly frequency then increasing (from three to four sessions per week). The video lesson will be available on a digital platform. Before, after eight weeks, and after 16 weeks, cardiovascular, autonomic, mental and cognitive health parameters will be assessed. Furthermore, the biomarkers Brain-Derived Neurotrophic Factor (BDNF), serotonin, and nitric oxide will be analyzed at different assessment times of the study, as well as biochemical profile tests (glucose, total cholesterol, among others), functional capacity tests, and body composition. This project is expected to contribute to the literature by better elucidating the effects of Yoga on the cardiovascular, mental, and cognitive health of hypertensive individuals. The SPSS (21.0) statistical package will be used for data analysis. After confirming the appropriate assumptions, generalized estimating equations will be used, followed by the Bonferroni post hoc test, with a significance level of 5%.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| YOGA | Experimental | Behavioral: YOGAThe GY will receive an intervention involving Yoga Training (TY), which will be divided into two phases: Phase 1 (first eight weeks), which will be supervised, with three weekly sessions lasting 60 minutes, and Phase 2 (the following eight weeks), which will consist of three supervised sessions per week and the delivery of an asynchronous video lesson via a digital platform, with an incremental session of one session per week. Classes will also be 60 minutes long. The supervised sessions will take place at the UFSC CDS rehabilitation center. TY sessions will follow the following structure: breathing techniques (Pranayama), warm-up (Pavana Muktasana), physical postures in standing, sitting, and lying positions (Asanas), and relaxation (Yoganidrá). The postures will be prescribed by holding time in seconds (30 to 40 seconds), number of sets, and rest between sets. Each session will include beginner, intermediate, and advanced postures. |
| CONTROL | Other | Behavioral: ControlThe CG will not receive any intervention during the study and, like the GY subjects, will be instructed not to change their routines. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults or elderly individuals
- >= 40 years
- Both sexes
- Diagnosis of hypertension controlled by up to three medications
- Who do not present high cardiovascular risk
Key exclusion criteria (5 listed)
- Adherence of less than 75% of training sessions
- Diagnosis of other diseases during the study
- Adherence to another physical exercise program
- Change in the class and/or dose of antihypertensive medication during the study
- Worsening of the disease (resting systolic blood pressure (BP) > 180 mmHg).
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 |
|---|---|---|
| YOGAThe participants randomized to the yoga group will perform 16 weeks of yoga training, three times/week for 60 minutes. | Behavioural | YOGA |
| ControlUsual care | Behavioural | CONTROL |
Primary outcome
Blood Pressure
Time frame: Baseline, 8 and 16 weeks
Clinical BP (Systolic and Diastolic) will be measured using an oscillometric device (Omron HEM 742) (OMRON Healthcare, Kyoto, Japan), according to current recommendations, while ambulatory BP will be assessed over 24 hours using a DynaMAPA device (Cardios), both in accordance with current recommendations (FEITOSA et al., 2024).
8 secondary outcomes
Quality of life
Time frame: Baseline, 8 and 16 weeks
Cognitive function
Time frame: Baseline, 8 and 16 weeks
Sleep Quality
Time frame: Baseline, 8 and 16 weeks
Depressive Symptoms
Time frame: Baseline, 8 and 16 weeks
Stress
Time frame: Baseline, 8 and 16 weeks
Attention and inhibitory response capacity
Time frame: Baseline, 8 and 16 weeks
Health related quality of life
Time frame: Baseline, 8 and 16 weeks
Anxiety
Time frame: Baseline, 8 and 16 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- 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.
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 in people with Hypertension, run by Universidade Federal de Santa Catarina 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 6 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 22 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aline Gerage, PhD (554837218554, alinegerage@yahoo.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Pressure (time frame: Baseline, 8 and 16 weeks). 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 22 Jun 2026.