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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03993184
Other study ID # 2018381
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 17, 2018
Est. completion date December 1, 2021

Study information

Verified date March 2021
Source Texas State University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. Participants will receive 12 weeks of free yoga for their participation.


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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date December 1, 2021
Est. primary completion date December 1, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Hot Yoga
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.

Locations

Country Name City State
United States Texas State University San Marcos Texas

Sponsors (1)

Lead Sponsor Collaborator
Texas State University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Averages in ambulatory blood pressure and vascular function Blood pressure monitoring using an arm cuff for one full day before and after the intervention 24 hours
Secondary 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. 5 minutes
Secondary 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. 15 minutes
Secondary 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. 10 minutes
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