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The Effects of Hot Yoga on Vascular Function

Primary Purpose

Hypertension, Elevated Blood Pressure

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hot Yoga
Sponsored by
Texas State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Texas State University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

90-minute Hot Yoga Classes

60-minute Hot Yoga Classes

Control

Arm Description

This group will complete 3, 90-minute hot yoga classes weekly for 12 weeks.

This group will complete 3, 60-minute hot yoga classes weekly for 12 weeks.

This group will maintain their current physical activity for 12 weeks.

Outcomes

Primary Outcome Measures

Averages in ambulatory blood pressure and vascular function
Blood pressure monitoring using an arm cuff for one full day before and after the intervention

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
March 6, 2018
Last Updated
October 25, 2022
Sponsor
Texas State University
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1. Study Identification

Unique Protocol Identification Number
NCT03993184
Brief Title
The Effects of Hot Yoga on Vascular Function
Official Title
The Effects of Bikram (Hot) Yoga on Vascular Health in Hypertensive Adults
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
April 17, 2018 (Actual)
Primary Completion Date
December 1, 2021 (Actual)
Study Completion Date
December 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Texas State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Elevated Blood Pressure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
90-minute Hot Yoga Classes
Arm Type
Experimental
Arm Description
This group will complete 3, 90-minute hot yoga classes weekly for 12 weeks.
Arm Title
60-minute Hot Yoga Classes
Arm Type
Experimental
Arm Description
This group will complete 3, 60-minute hot yoga classes weekly for 12 weeks.
Arm Title
Control
Arm Type
No Intervention
Arm Description
This group will maintain their current physical activity for 12 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Hot Yoga
Intervention Description
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.
Primary Outcome Measure Information:
Title
Averages in ambulatory blood pressure and vascular function
Description
Blood pressure monitoring using an arm cuff for one full day before and after the intervention
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Perceived stress
Description
"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.
Time Frame
5 minutes
Title
Brachial artery endothelial function
Description
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.
Time Frame
15 minutes
Title
Arterial Stiffness
Description
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.
Time Frame
10 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Monica Gonzales
Organizational Affiliation
Texas State University IRB
Official's Role
Study Chair
Facility Information:
Facility Name
Texas State University
City
San Marcos
State/Province
Texas
ZIP/Postal Code
78666
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effects of Hot Yoga on Vascular Function

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