NCT02488148

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. 1.Bikram yoga will elicit reductions in arterial stiffness and enhancements in endothelial function in sedentary, middle-aged adults.
  2. 2.The postulated effects of Bikram yoga will be greater when practiced in a heated environment.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
81

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

June 24, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 2, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2016

Completed
Last Updated

October 12, 2018

Status Verified

October 1, 2018

Enrollment Period

3.3 years

First QC Date

June 24, 2015

Last Update Submit

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

EXPERIMENTAL

3 hot yoga classes per week to be completed at local studios in Austin, TX.

Behavioral: Hot yoga

Non-heated yoga

EXPERIMENTAL

3 yoga classes to be completed at local studios in Austin, TX.

Behavioral: Non-heated yoga

Control

NO INTERVENTION

Maintain usual activities for the 12-week duration of the study.

Interventions

Hot yogaBEHAVIORAL

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.

Also known as: Bikram yoga
Hot yoga
Non-heated yogaBEHAVIORAL

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 yoga

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

Location

Study Officials

  • Stacy Hunter, PhD

    University of Texas

    PRINCIPAL INVESTIGATOR

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

Locations