AgingNCT02488148
The Effect of Bikram Yoga on Arterial Stiffness and Endothelial Function in Middle-Aged Adults
A study testing Hot yoga and Non-heated yoga in people with Aging, run by University of Texas at Austin at 1 site in United States.
Trial summary
Arterial stiffening and endothelial dysfunction are correlates of advancing age contributing to the decline in cardioprotection with age. Arterial stiffness and endothelial dysfunction are emerging risk factors for cardiovascular disease and predict future cardiac events. Read more about this study
- Who is it for?
- Ages 40 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Hot yoga and Non-heated yoga
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to 30 Dec 2016
- 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 40 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- A total of 80 sedentary (<2 days of physical activity weekly) male and female adults between the ages of 40 and 60 years will be recruited and studied.
Who cannot join
- pregnancy (if the subject is unsure about her status, a simple testing kit will be made available to the subject)
- Uncontrolled hypertension (blood pressure >160/100 mmHg while on hypertensive medications)
- Infection within the previous 4 weeks
- Having adrenal or endocrine tumors
- Renal disease
- Prior myocardial infarction (heart attack)
Show all 19Show fewer
- Known coronary artery disease
- Personal history of stroke
- Heart failure
- Cardiac arrhythmias
- Chronic obstructive pulmonary disease
- Personal history of psychosis
- Diabetes
- Having a body mass index ≥35 kg/m2
- Recent chest pain or dyspnea
- Orthopedic limitations that prevent them from being able to perform the yoga postures
- Heat intolerance
- Having undergone a barium test within the previous two weeks
- Having had a nuclear medicine scan or injection with x-ray dye within the previous week.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cardiovascular Aging Research Laboratory
Austin, Texas, 78712
About this study
Official title: Bikram Yoga and Vascular Health
Arterial stiffening and endothelial dysfunction are correlates of advancing age contributing to the decline in cardioprotection with age. Arterial stiffness and endothelial dysfunction are emerging risk factors for cardiovascular disease and predict future cardiac events. Vascular function has long been a target for lifestyle interventions with several studies showing improvements traditional exercise modes. However, the impact of yoga on vascular function remains elusive. This study will determine the effect of a 12-week Bikram yoga intervention on arterial stiffness and endothelial function in healthy, middle-aged adults.
The overall aim of this study is to determine the efficacy of Bikram yoga in improving vascular endothelial function and arterial distensibility in middle-aged adults with risk factors for coronary artery disease and to determine whether the heated environment plays a role in mediating these alterations in vascular function. The investigators propose to conduct a 12-week Bikram yoga intervention study in sedentary individuals in order to test the following hypotheses:
- Bikram yoga will elicit reductions in arterial stiffness and enhancements in endothelial function in sedentary, middle-aged adults.
- The postulated effects of Bikram yoga will be greater when practiced in a heated environment.
Read the detailed description
Bikram yoga is a trademarked form of yoga in which a series of 26 yoga postures are performed in a heated (41ºC), humidified environment over a 90-minute period. Bikram yoga has rapidly gained popularity with approximately 300 studios currently operating in the U.S. The 90-minute session consists of pranayama (breathing), and standing, balancing, strengthening, and stretching asanas (postures) all performed in a sauna-like environment. Although this highly controlled style of yoga provides an optimal choice for interventional research studies, few studies have attempted to elucidate the health benefits associated with Bikram yoga.
Subjects will be randomly assigned to one of three groups: heated Bikram yoga (41ºC), room temperature Bikram yoga (22ºC), or control in which the participants will be instructed not to alter physical activity patterns. Collected data from this interventional study will be analyzed by ANOVA and/or ANCOVA with repeated measures. Pearson correlation coefficients will be used to examine associations between variables of interest. A significance level of p<0.05 will be employed to determine statistical significance.
A total of 80 sedentary (<2 days of physical activity weekly) male and female adults between the ages of 40 and 60 years will be recruited and studied. Twenty subjects in each group will complete 12 weeks of Bikram yoga at room temperature (22ºC), Bikram yoga in a heated environment (41ºC), or a control period during which participants will be instructed not to alter physical activity levels. Based on a previous study competed by the investigators which employed Bikram yoga as an intervention, a dropout rate of 25% is anticipated. Therefore, as the goal of the investigators is to have a minimum of 60 subjects (20 per group) complete the 12-week intervention, the investigators will recruit and enroll 80 subjects.
Once participants report to the laboratory, height and weight will be measured and a finger prick will be performed. Body composition will then be measured via dual energy x-ray absorptiometry scan.
Endothelial function will be measured non-invasively via flow-mediated dilation. This technique involves ultrasound imaging of the upper arm to obtain an image of the brachial artery. Once baseline images are acquired, a cuff placed around the forearm will be inflated for 5 minutes. More images will be acquired after the cuff is deflated and the images will be analyzed to determine the percent change in arterial diameter from baseline.
Arterial stiffness will be measured using pulse wave velocity. Tonometric sensors will be placed on the carotid and femoral pulse sites and blood pressure cuffs placed on the arms and ankles to determine brachial and tibial arterial blood pressure. The distance between the carotid and femoral pulse sites will be measured and pulse wave velocity will be determined as distance traveled divided by the time between the initiation of the carotid and femoral pulses.
- Conditions
- Aging
- Being tested
- Hot yoga, Non-heated yoga
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hot yogaBehavioural
Also called Bikram yoga
Subjects in the two intervention groups will complete the standard 26-posture Bikram yoga series in a studio heated at 41ºC (traditional environment) or in a studio at a room temperature of 22ºC whereas control group subjects will be instructed to maintain physical activity patterns for the 12-week study duration. Yoga classes will be held at the Pure Bikram Yoga downtown Austin location. Classes will be completed 3 times weekly for 12 weeks and consist of 90 minutes of yoga postures and breathing exercises.
Non-heated yogaBehavioural
Subjects in the two intervention groups will complete the standard 26-posture Bikram yoga series in a studio heated at 41ºC (traditional environment) or in a studio at a room temperature of 22ºC whereas control group subjects will be instructed to maintain physical activity patterns for the 12-week study duration. Yoga classes will be held at the Pure Bikram Yoga downtown Austin location. Classes will be completed 3 times weekly for 12 weeks and consist of 90 minutes of yoga postures and breathing exercises.
| Study group | Role | What they receive |
|---|---|---|
| Hot yoga | Experimental | 3 hot yoga classes per week to be completed at local studios in Austin, TX. Receives: Behavioral: Hot yoga |
| Non-heated yoga | Experimental | 3 yoga classes to be completed at local studios in Austin, TX. Receives: Behavioral: Non-heated yoga |
| Control | No intervention | Maintain usual activities for the 12-week duration of the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brachial artery flow-mediated dilation
Endothelial function will be measured non-invasively via flow-mediated dilation at baseline and after 12 weeks. This technique involves ultrasound imaging of the upper arm to obtain an image of the brachial artery. Once baseline images are acquired, a cuff placed around the forearm will be inflated for 5 minutes. More images will be acquired after the cuff is deflated and the images will be analyzed to determine the percent change in arterial diameter from baseline.
Measured: 12 weeks
Arterial stiffness (pulse wave velocity)
Arterial stiffness will be measured using pulse wave velocity at baseline and 12 weeks. Tonometric sensors will be placed on the carotid and femoral pulse sites and blood pressure cuffs places on the arms and ankles to determine brachial and tibial arterial blood pressure. The distance between the carotid and femoral pulse sites will be measured and pulse wave velocity will be determined as distance traveled divided by the time between the initiation of the carotid and femoral pulses.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2015 (estimated)
- Study startSep 2013
- Primary completion30 Dec 2016
- Study completion30 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by University of Texas at AustinThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stacy D. Hunter, University of Texas at Austin
- Investigators
- Stacy Hunter, PhD, Principal investigator, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02488148
- Sponsor's protocol ID
- 2012-12-0043
- Status last verified
- Oct 2018
- First submitted
- 24 Jun 2015
- Last updated
- 12 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bikram Yoga and Vascular Health
- ClinicalTrials.gov ID
- NCT02488148
- Acronym / sponsor ID
- 2012-12-0043
- Conditions
- Aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- 30 Dec 2016 (actual)
- Study completion
- 30 Dec 2016 (actual)
- First posted
- 2 Jul 2015 (estimated)
- 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.
Arterial stiffening and endothelial dysfunction are correlates of advancing age contributing to the decline in cardioprotection with age. Arterial stiffness and endothelial dysfunction are emerging risk factors for cardiovascular disease and predict future cardiac events. Vascular function has long been a target for lifestyle interventions with several studies showing improvements traditional exercise modes. However, the impact of yoga on vascular function remains elusive. This study will determine the effect of a 12-week Bikram yoga intervention on arterial stiffness and endothelial function in healthy, middle-aged adults.
The overall aim of this study is to determine the efficacy of Bikram yoga in improving vascular endothelial function and arterial distensibility in middle-aged adults with risk factors for coronary artery disease and to determine whether the heated environment plays a role in mediating these alterations in vascular function. The investigators propose to conduct a 12-week Bikram yoga intervention study in sedentary individuals in order to test the following hypotheses:
- Bikram yoga will elicit reductions in arterial stiffness and enhancements in endothelial function in sedentary, middle-aged adults.
- The postulated effects of Bikram yoga will be greater when practiced in a heated environment.
Detailed description
Bikram yoga is a trademarked form of yoga in which a series of 26 yoga postures are performed in a heated (41ºC), humidified environment over a 90-minute period. Bikram yoga has rapidly gained popularity with approximately 300 studios currently operating in the U.S. The 90-minute session consists of pranayama (breathing), and standing, balancing, strengthening, and stretching asanas (postures) all performed in a sauna-like environment. Although this highly controlled style of yoga provides an optimal choice for interventional research studies, few studies have attempted to elucidate the health benefits associated with Bikram yoga.
Subjects will be randomly assigned to one of three groups: heated Bikram yoga (41ºC), room temperature Bikram yoga (22ºC), or control in which the participants will be instructed not to alter physical activity patterns. Collected data from this interventional study will be analyzed by ANOVA and/or ANCOVA with repeated measures. Pearson correlation coefficients will be used to examine associations between variables of interest. A significance level of p<0.05 will be employed to determine statistical significance.
A total of 80 sedentary (<2 days of physical activity weekly) male and female adults between the ages of 40 and 60 years will be recruited and studied. Twenty subjects in each group will complete 12 weeks of Bikram yoga at room temperature (22ºC), Bikram yoga in a heated environment (41ºC), or a control period during which participants will be instructed not to alter physical activity levels. Based on a previous study competed by the investigators which employed Bikram yoga as an intervention, a dropout rate of 25% is anticipated. Therefore, as the goal of the investigators is to have a minimum of 60 subjects (20 per group) complete the 12-week intervention, the investigators will recruit and enroll 80 subjects.
Once participants report to the laboratory, height and weight will be measured and a finger prick will be performed. Body composition will then be measured via dual energy x-ray absorptiometry scan.
Endothelial function will be measured non-invasively via flow-mediated dilation. This technique involves ultrasound imaging of the upper arm to obtain an image of the brachial artery. Once baseline images are acquired, a cuff placed around the forearm will be inflated for 5 minutes. More images will be acquired after the cuff is deflated and the images will be analyzed to determine the percent change in arterial diameter from baseline.
Arterial stiffness will be measured using pulse wave velocity. Tonometric sensors will be placed on the carotid and femoral pulse sites and blood pressure cuffs placed on the arms and ankles to determine brachial and tibial arterial blood pressure. The distance between the carotid and femoral pulse sites will be measured and pulse wave velocity will be determined as distance traveled divided by the time between the initiation of the carotid and femoral pulses.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hot yoga | Experimental | Behavioral: Hot yoga3 hot yoga classes per week to be completed at local studios in Austin, TX. |
| Non-heated yoga | Experimental | Behavioral: Non-heated yoga3 yoga classes to be completed at local studios in Austin, TX. |
| Control | No intervention | –Maintain usual activities for the 12-week duration of the study. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- A total of 80 sedentary (<2 days of physical activity weekly) male and female adults between the ages of 40 and 60 years will be recruited and studied.
Key exclusion criteria (19 listed)
- pregnancy (if the subject is unsure about her status, a simple testing kit will be made available to the subject)
- Uncontrolled hypertension (blood pressure >160/100 mmHg while on hypertensive medications)
- Infection within the previous 4 weeks
- Having adrenal or endocrine tumors
- Renal disease
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 yogaAlso: Bikram yogaSubjects in the two intervention groups will complete the standard 26-posture Bikram yoga series in a studio heated at 41ºC (traditional environment) or in a studio at a room temperature of 22ºC whereas control group subjects will be instructed to maintain physical activity patterns for the 12-week study duration. Yoga classes will be held at the Pure Bikram Yoga downtown Austin location. Classes will be completed 3 times weekly for 12 weeks and consist of 90 minutes of yoga postures and breathing exercises. | Behavioural | Hot yoga |
| Non-heated yogaSubjects in the two intervention groups will complete the standard 26-posture Bikram yoga series in a studio heated at 41ºC (traditional environment) or in a studio at a room temperature of 22ºC whereas control group subjects will be instructed to maintain physical activity patterns for the 12-week study duration. Yoga classes will be held at the Pure Bikram Yoga downtown Austin location. Classes will be completed 3 times weekly for 12 weeks and consist of 90 minutes of yoga postures and breathing exercises. | Behavioural | Non-heated yoga |
Primary outcome
Brachial artery flow-mediated dilation
Time frame: 12 weeks
Endothelial function will be measured non-invasively via flow-mediated dilation at baseline and after 12 weeks. This technique involves ultrasound imaging of the upper arm to obtain an image of the brachial artery. Once baseline images are acquired, a cuff placed around the forearm will be inflated for 5 minutes. More images will be acquired after the cuff is deflated and the images will be analyzed to determine the percent change in arterial diameter from baseline.
Arterial stiffness (pulse wave velocity)
Time frame: 12 weeks
Arterial stiffness will be measured using pulse wave velocity at baseline and 12 weeks. Tonometric sensors will be placed on the carotid and femoral pulse sites and blood pressure cuffs places on the arms and ankles to determine brachial and tibial arterial blood pressure. The distance between the carotid and femoral pulse sites will be measured and pulse wave velocity will be determined as distance traveled divided by the time between the initiation of the carotid and femoral pulses.
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 12 Oct 2018.
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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.
Stacy Hunter, PhD principal investigator
University of Texas
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 and Non-heated yoga in people with Aging, run by University of Texas at Austin 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 1 inclusion and 19 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 12 Oct 2018. 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?
Brachial artery flow-mediated dilation (time frame: 12 weeks). 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 12 Oct 2018.