The Effect of Bikram Yoga on Arterial Stiffness and Endothelial Function in Middle-Aged Adults
Bikram Yoga and Vascular Health
1 other identifier
interventional
81
1 country
1
Brief 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. 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:
- 1.Bikram yoga will elicit reductions in arterial stiffness and enhancements in endothelial function in sedentary, middle-aged adults.
- 2.The postulated effects of Bikram yoga will be greater when practiced in a heated environment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2013
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2013
CompletedFirst Submitted
Initial submission to the registry
June 24, 2015
CompletedFirst Posted
Study publicly available on registry
July 2, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2016
CompletedOctober 12, 2018
October 1, 2018
3.3 years
June 24, 2015
October 9, 2018
Conditions
Outcome Measures
Primary Outcomes (2)
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.
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.
12 weeks
Study Arms (3)
Hot yoga
EXPERIMENTAL3 hot yoga classes per week to be completed at local studios in Austin, TX.
Non-heated yoga
EXPERIMENTAL3 yoga classes to be completed at local studios in Austin, TX.
Control
NO INTERVENTIONMaintain usual activities for the 12-week duration of the study.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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)
- 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
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cardiovascular Aging Research Laboratory
Austin, Texas, 78712, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Stacy Hunter, PhD
University of Texas
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- University Affiliate
Study Record Dates
First Submitted
June 24, 2015
First Posted
July 2, 2015
Study Start
September 1, 2013
Primary Completion
December 30, 2016
Study Completion
December 30, 2016
Last Updated
October 12, 2018
Record last verified: 2018-10