- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03993184
The Effects of Hot Yoga on Vascular Function
October 25, 2022 updated by: Texas State University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
San Marcos, Texas, United States, 78666
- Texas State University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 61 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Elevated blood pressure or stage I hypertension;
- sedentary (not currently exercising regularly);
- not currently taking blood pressure medications.
Exclusion Criteria:
- Pregnancy;
- renal disease;
- prior heart attack;
- known coronary artery disease;
- history of stroke,
- heart failure, cardiac arrhythmias or chronic obstructive pulmonary disease (COPD);
- recent chest pain;
- heat intolerance;
- body mass index of 40 or more.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 90-minute Hot Yoga Classes
This group will complete 3, 90-minute hot yoga classes weekly for 12 weeks.
|
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.
|
|
Experimental: 60-minute Hot Yoga Classes
This group will complete 3, 60-minute hot yoga classes weekly for 12 weeks.
|
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.
|
|
No Intervention: Control
This group will maintain their current physical activity for 12 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Perceived stress
Time Frame: 5 minutes
|
"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.
|
5 minutes
|
|
Brachial artery endothelial function
Time Frame: 15 minutes
|
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.
|
15 minutes
|
|
Arterial Stiffness
Time Frame: 10 minutes
|
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.
|
10 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Monica Gonzales, Texas State University IRB
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 17, 2018
Primary Completion (Actual)
December 1, 2021
Study Completion (Actual)
December 1, 2021
Study Registration Dates
First Submitted
March 6, 2018
First Submitted That Met QC Criteria
June 19, 2019
First Posted (Actual)
June 20, 2019
Study Record Updates
Last Update Posted (Actual)
October 27, 2022
Last Update Submitted That Met QC Criteria
October 25, 2022
Last Verified
March 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018381
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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