HypertensionNCT03993184
The Effects of Hot Yoga on Vascular Function
A study testing Hot Yoga in people with Hypertension and Elevated Blood Pressure, run by Texas State University at 1 site in United States.
Trial summary
This study will examine the effects of a 12 week hot yoga intervention on vascular health in adults between the ages of 20 and 65. The investigators are seeking individuals with slightly elevated blood pressure and stage I hypertension who are not currently taking blood pressure medications or exercising regularly. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Elevated Blood Pressure
- What is being tested?
- Hot Yoga
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Apr 2018to 1 Dec 2021
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Elevated blood pressure or stage I hypertension;
- sedentary (not currently exercising regularly);
- not currently taking blood pressure medications.
Who cannot join
- Pregnancy;
- renal disease;
- prior heart attack;
- known coronary artery disease;
- history of stroke,
- heart failure, cardiac arrhythmias or chronic obstructive pulmonary disease (COPD);
Show all 9Show fewer
- recent chest pain;
- heat intolerance;
- body mass index of 40 or more.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Bikram (Hot) Yoga on Vascular Health in Hypertensive Adults
This study will examine the effects of a 12 week hot yoga intervention on vascular health in adults between the ages of 20 and 65. The investigators are seeking individuals with slightly elevated blood pressure and stage I hypertension who are not currently taking blood pressure medications or exercising regularly. Participants will receive 12 weeks of free yoga for their participation.
Read the detailed description
This study will examine the effects of a 12 week hot yoga intervention on vascular health by assessing changes of pre-intervention and post-intervention measurements in ambulatory blood pressure, endothelial function, and arterial stiffness in adults between the ages of 20 and 65. The investigators are seeking individuals with elevated blood pressure and stage I hypertension who are not currently taking blood pressure medications or exercising regularly. Participants will receive 12 weeks of free yoga for their participation.
- Conditions
- Hypertension, Elevated Blood Pressure
- Being tested
- Hot Yoga
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hot YogaBehavioural
Bikram or hot yoga is a standardized series of 26 postures with two breathing exercises. Classes will be performed at local yoga studios in Austin, Texas and participants will be required to sign in for each session. All participants will receive 12 weeks of free classes for their participation.
| Study group | Role | What they receive |
|---|---|---|
| 90-minute Hot Yoga Classes | Experimental | This group will complete 3, 90-minute hot yoga classes weekly for 12 weeks. Receives: Behavioral: Hot Yoga |
| 60-minute Hot Yoga Classes | Experimental | This group will complete 3, 60-minute hot yoga classes weekly for 12 weeks. Receives: Behavioral: Hot Yoga |
| Control | No intervention | This group will maintain their current physical activity for 12 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Averages in ambulatory blood pressure and vascular function
Blood pressure monitoring using an arm cuff for one full day before and after the intervention
Measured: 24 hours
Secondary outcomes (3)
Perceived stress
"Perceived Stress Scale" questionnaire will be filled out by participant before and after the intervention in order to asses current perception of stress of daily living. 10 total questions, scaled from 0 to 4, 4 being the most often a participant felt stress and carries a weight of 5 and 0 holds a weight of 1. Question 4, 5, 7, and 8 have reversed values where 0 is the most heavily weighted and 4 is the least. The total is added up upon completion of each test and can be compared to before and after values.
Measured: 5 minutes
Brachial artery endothelial function
Ultrasound imaging of the upper arm before and after 5 minutes of lower arm cuff inflation (this cuff similar to a blood pressure cuff but smaller) before and after the intervention. Arterial diameter images will be analyzed for baseline and post-cuff release diameters and flow-mediated dilation will be quantified as the percentage change in arterial diameter from baseline.
Measured: 15 minutes
Arterial Stiffness
Tonometry readings of the carotid and femoral artery pulses assessing pulse wave velocity before and after the intervention. Pulse wave velocity will be determined by dividing the distance traveled in millimeters by the time delay between the initiations of the carotid and femoral pulse waveforms in seconds.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2019
- Study start17 Apr 2018
- Primary completion1 Dec 2021
- Study completion1 Dec 2021
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
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Monica Gonzales, Study chair, Texas State University IRB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03993184
- Sponsor's protocol ID
- 2018381
- Status last verified
- Mar 2021
- First submitted
- 6 Mar 2018
- Last updated
- 27 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Bikram (Hot) Yoga on Vascular Health in Hypertensive Adults
- ClinicalTrials.gov ID
- NCT03993184
- Acronym / sponsor ID
- 2018381
- Conditions
- Hypertension, Elevated Blood Pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Texas State UniversityUniversity, hospital or other
- Study start
- 17 Apr 2018 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 20 Jun 2019 (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.
This study will examine the effects of a 12 week hot yoga intervention on vascular health in adults between the ages of 20 and 65. The investigators are seeking individuals with slightly elevated blood pressure and stage I hypertension who are not currently taking blood pressure medications or exercising regularly. Participants will receive 12 weeks of free yoga for their participation.
Detailed description
This study will examine the effects of a 12 week hot yoga intervention on vascular health by assessing changes of pre-intervention and post-intervention measurements in ambulatory blood pressure, endothelial function, and arterial stiffness in adults between the ages of 20 and 65. The investigators are seeking individuals with elevated blood pressure and stage I hypertension who are not currently taking blood pressure medications or exercising regularly. Participants will receive 12 weeks of free yoga for their participation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 90-minute Hot Yoga Classes | Experimental | Behavioral: Hot YogaThis group will complete 3, 90-minute hot yoga classes weekly for 12 weeks. |
| 60-minute Hot Yoga Classes | Experimental | Behavioral: Hot YogaThis group will complete 3, 60-minute hot yoga classes weekly for 12 weeks. |
| Control | No intervention | –This group will maintain their current physical activity for 12 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Elevated blood pressure or stage I hypertension;
- sedentary (not currently exercising regularly);
- not currently taking blood pressure medications.
Key exclusion criteria (9 listed)
- Pregnancy;
- renal disease;
- prior heart attack;
- known coronary artery disease;
- history of stroke,
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 |
|---|---|---|
| Hot YogaBikram or hot yoga is a standardized series of 26 postures with two breathing exercises. Classes will be performed at local yoga studios in Austin, Texas and participants will be required to sign in for each session. All participants will receive 12 weeks of free classes for their participation. | Behavioural | 60-minute Hot Yoga Classes, 90-minute Hot Yoga Classes |
Primary outcome
Averages in ambulatory blood pressure and vascular function
Time frame: 24 hours
Blood pressure monitoring using an arm cuff for one full day before and after the intervention
3 secondary outcomes
Perceived stress
Time frame: 5 minutes
Brachial artery endothelial function
Time frame: 15 minutes
Arterial Stiffness
Time frame: 10 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 27 Oct 2022.
- Individual participant dataSharing planned: No
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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.
Monica Gonzales study chair
Texas State University IRB
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hot Yoga in people with Hypertension and Elevated Blood Pressure, 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 3 inclusion and 9 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 27 Oct 2022. 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. 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?
Averages in ambulatory blood pressure and vascular function (time frame: 24 hours). 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 27 Oct 2022; AzTrials last refreshed its copy on 30 Oct 2026.