HypertensionNCT05158205
Yoga in Altering Mechanistic Outcomes in Hypertension
A study testing Yoga and Slow, deep breathing in people with Hypertension, run by Texas State University at 1 site in United States.
Trial summary
The proposed study will assess the effects of yoga postures and slow, deep breathing in altering oxidative stress, vascular function, and blood pressure. Read more about this study
- Who is it for?
- Ages 30 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- Yoga and Slow, deep breathing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jul 2022to 30 Nov 2024
- 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 30 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
None listed.
Who cannot join
- pregnancy (tests will be administered to all premenopausal females at initial screening and follow up visits);
- having taken blood pressure or statin medications within the past 3 months (statins have been demonstrated to reduce oxidative stress);
- infection (viral or other) within the past 4 weeks;
- having adrenal or endocrine tumors (these could impact blood pressure);
- renal disease defined as an estimate glomerular filtration rate (eGFR) of less than 60 (creatinine will be tested at initial screening and eGFR will be calculated);
- hyperaldosteronism;
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- prior myocardial infarction;
- known coronary heart disease;
- personal history of stroke;
- heart failure;
- cardiac arrhythmias;
- chronic obstructive pulmonary disease, asthma, or other airflow obstructions;
- recent chest pain or dyspnea;
- orthopedic limitations that preclude the execution of yoga postures;
- current insulin dependence;
- chronic inflammatory conditions (e.g., rheumatoid arthritis, lupus, HIV/AIDS, ulcerative colitis, or Crohn's disease);
- currently taking steroid or other anti-inflammatory medication;
- currently undergoing chemotherapy or radiation;
- having practiced yoga or slow, deep breathing at least once weekly within the past 6 months;
- currently smoking or having quit within the last 6 months;
- Raynaud's disease, peripheral vascular disease, or arteritis.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cardiovascular Physiology Laboratory-Texas State University
San Marcos, Texas, 78666
About this study
Official title: Yoga Postures and Slow, Deep Breathing in Altering Mechanistic Outcomes in Hypertension
The proposed study will assess the effects of yoga postures and slow, deep breathing in altering oxidative stress, vascular function, and blood pressure.
Read the detailed description
The purpose of this study is to determine the mechanism by which yoga lowers blood pressure in hypertensive adults.
Free radicals and enzyme activity will be analyzed from isolated immune cells and blood pressure and vascular health will be assessed at baseline and at weeks 4, 8, and 12 during the interventions or control conditions. Sedentary adults (ages 30-60 years) with elevated blood pressure or stage I hypertension will be recruited and randomized to 12 weeks of yoga, video-based breathing, or app-based breathing conditions. Yoga classes will be completed 3 times weekly at Texas State University and slow, deep breathing interventions will be completed at home 5 times weekly. Participants assigned to the app-based breathing group will also complete 5- 20-minute breathing exercises per week at home before being re-randomization at week 12. Three testing sessions will be completed at the beginning of the study: 1) familiarization and screening for elevated blood pressure or hypertension and other exclusion criteria; 2) confirmation of elevated blood pressure or hypertension via addition seated blood pressure measurements and 24-hour ambulatory blood pressure and 3-day physical activity monitoring; and 3) blood marker assessment and endothelial function measurements.
All outcomes will be measured at baseline and at 4-week intervals throughout the 12-week data collection period in all 3 groups. At each follow up visit after randomization, testing will be completed over the course of 2 sessions: 1) ambulatory blood pressure monitor and physical activity monitoring and 2) blood marker and endothelial function measurements. At the end of the waitlist sham/control period, waitlisted participants will be rerandomized to yoga or slow, deep breathing interventions. Once re-randomized, participants in each group will complete follow up testing 4,8, and 12 weeks into their respective interventions.
- Conditions
- Hypertension
- Being tested
- Yoga, Slow, deep breathing, Control breathing
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YogaBehavioural
12-week yoga intervention in which 60-minute classes are completed at Texas State University 3 times per week
Slow, deep breathingBehavioural
12-week home-based intervention in which 5 weekly 20-minute breathing sessions are completed
Control breathingBehavioural
12-week home-based intervention in which 5 weekly 20-minute breathing sessions are completed
| Study group | Role | What they receive |
|---|---|---|
| Yoga postures or slow, deep breathing | Experimental | Not described Receives: Behavioral: Yoga; Behavioral: Slow, deep breathing |
| Control | Sham comparator | Not described Receives: Behavioral: Control breathing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in peripheral blood mononuclear cell reactive oxygen species
Blood draws will be performed at baseline and at weeks 4, 8, and 12 during the study after randomization and analyzed for free radicals after white blood cells are separated from whole blood.
Measured: Baseline and week 4, 8, and 12 measurements
Change in peripheral blood mononuclear cell NADPH oxidase cell NADPH oxidase enzyme activity
A portion of the white blood cells isolated from a whole blood sample will be frozen and later analyzed for enzyme activity. This will be completed for blood samples obtained at baseline and weeks 4, 8, and 12.
Measured: Baseline and week 4, 8, and 12 measurements
Secondary outcomes (3)
Change in 24-hour blood pressure
An automated cuff will be worn for 24 hours while the devices takes automatic measurements every 30 minutes.
Measured: Baseline and week 4, 8, and 12 measurements
Change in flow-mediated dilation
A cuff will placed around the forearm while an ultrasound probe is held on the upper arm to obtain a brachial artery image. The forearm cuff will be inflated for 5 minutes, then ultrasound images of the upper arm will be obtained for 3 minutes after cuff deflation.
Measured: Baseline and week 4, 8, and 12 measurements
Change in microvascular endothelial function/thermal hyperemia
A small probe will be secured on the forearm and gradually heated for 45 minutes.
Measured: Baseline and week 4, 8, and 12 measurements
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2021
- Study start11 Jul 2022
- Primary completion30 Nov 2024
- Study completion30 Nov 2024
Why it stopped: The project period ended prior to the completion of full enrollment.
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
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05158205
- Sponsor's protocol ID
- 7988
- Status last verified
- Apr 2025
- First submitted
- 8 Nov 2021
- Last updated
- 11 Apr 2025
- 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 11 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Yoga Postures and Slow, Deep Breathing in Altering Mechanistic Outcomes in Hypertension
- ClinicalTrials.gov ID
- NCT05158205
- Acronym / sponsor ID
- 7988
- Conditions
- Hypertension
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The project period ended prior to the completion of full enrollment.
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Texas State UniversityUniversity, hospital or other
- Study start
- 11 Jul 2022 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 15 Dec 2021 (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 proposed study will assess the effects of yoga postures and slow, deep breathing in altering oxidative stress, vascular function, and blood pressure.
Detailed description
The purpose of this study is to determine the mechanism by which yoga lowers blood pressure in hypertensive adults.
Free radicals and enzyme activity will be analyzed from isolated immune cells and blood pressure and vascular health will be assessed at baseline and at weeks 4, 8, and 12 during the interventions or control conditions. Sedentary adults (ages 30-60 years) with elevated blood pressure or stage I hypertension will be recruited and randomized to 12 weeks of yoga, video-based breathing, or app-based breathing conditions. Yoga classes will be completed 3 times weekly at Texas State University and slow, deep breathing interventions will be completed at home 5 times weekly. Participants assigned to the app-based breathing group will also complete 5- 20-minute breathing exercises per week at home before being re-randomization at week 12. Three testing sessions will be completed at the beginning of the study: 1) familiarization and screening for elevated blood pressure or hypertension and other exclusion criteria; 2) confirmation of elevated blood pressure or hypertension via addition seated blood pressure measurements and 24-hour ambulatory blood pressure and 3-day physical activity monitoring; and 3) blood marker assessment and endothelial function measurements.
All outcomes will be measured at baseline and at 4-week intervals throughout the 12-week data collection period in all 3 groups. At each follow up visit after randomization, testing will be completed over the course of 2 sessions: 1) ambulatory blood pressure monitor and physical activity monitoring and 2) blood marker and endothelial function measurements. At the end of the waitlist sham/control period, waitlisted participants will be rerandomized to yoga or slow, deep breathing interventions. Once re-randomized, participants in each group will complete follow up testing 4,8, and 12 weeks into their respective interventions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Yoga postures or slow, deep breathing | Experimental | Behavioral: Yoga, Behavioral: Slow, deep breathing |
| Control | Sham comparator | Behavioral: Control breathing |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (21 listed)
- pregnancy (tests will be administered to all premenopausal females at initial screening and follow up visits);
- having taken blood pressure or statin medications within the past 3 months (statins have been demonstrated to reduce oxidative stress);
- infection (viral or other) within the past 4 weeks;
- having adrenal or endocrine tumors (these could impact blood pressure);
- renal disease defined as an estimate glomerular filtration rate (eGFR) of less than 60 (creatinine will be tested at initial screening and eGFR will be calculated);
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 |
|---|---|---|
| Yoga12-week yoga intervention in which 60-minute classes are completed at Texas State University 3 times per week | Behavioural | Yoga postures or slow, deep breathing |
| Slow, deep breathing12-week home-based intervention in which 5 weekly 20-minute breathing sessions are completed | Behavioural | Yoga postures or slow, deep breathing |
| Control breathing12-week home-based intervention in which 5 weekly 20-minute breathing sessions are completed | Behavioural | Control |
Primary outcome
Change in peripheral blood mononuclear cell reactive oxygen species
Time frame: Baseline and week 4, 8, and 12 measurements
Blood draws will be performed at baseline and at weeks 4, 8, and 12 during the study after randomization and analyzed for free radicals after white blood cells are separated from whole blood.
Change in peripheral blood mononuclear cell NADPH oxidase cell NADPH oxidase enzyme activity
Time frame: Baseline and week 4, 8, and 12 measurements
A portion of the white blood cells isolated from a whole blood sample will be frozen and later analyzed for enzyme activity. This will be completed for blood samples obtained at baseline and weeks 4, 8, and 12.
3 secondary outcomes
Change in 24-hour blood pressure
Time frame: Baseline and week 4, 8, and 12 measurements
Change in flow-mediated dilation
Time frame: Baseline and week 4, 8, and 12 measurements
Change in microvascular endothelial function/thermal hyperemia
Time frame: Baseline and week 4, 8, and 12 measurements
Results and safety
The study was stopped early (reason given: The project period ended prior to the completion of full enrollment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Slow, deep breathing in people with Hypertension, run by Texas State University at 1 site in United States.
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 0 inclusion and 21 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: stopped early, as of the sponsor's last update on 11 Apr 2025. 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 United States. 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. Some participants in this study may receive a placebo. 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 was stopped early (reason given: The project period ended prior to the completion of full enrollment.). Results are not available in the source record.
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?
Change in peripheral blood mononuclear cell reactive oxygen species (time frame: Baseline and week 4, 8, and 12 measurements). The study lists 2 primary outcomes in all. 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 11 Apr 2025.