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出境医 / 临床实验 / The Effects of Hot Yoga on Vascular Function

The Effects of Hot Yoga on Vascular Function

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.

Condition or disease Intervention/treatment Phase
Hypertension Elevated Blood Pressure Behavioral: Hot Yoga Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 169 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effects of Bikram (Hot) Yoga on Vascular Health in Hypertensive Adults
Actual Study Start Date : April 17, 2018
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : December 2022
Arms and Interventions
Arm Intervention/treatment
Experimental: 90-minute Hot Yoga Classes
This group will complete 3, 90-minute hot yoga classes weekly for 12 weeks.
 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.
Experimental: 60-minute Hot Yoga Classes
This group will complete 3, 60-minute hot yoga classes weekly for 12 weeks.
 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.
No Intervention: Control
This group will maintain their current physical activity for 12 weeks.
Outcome Measures
Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations

Contacts
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Contact: Stacy D. Hunter, PhD 512-245-8046 s_h393@txstate.edu

Locations
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United States, Texas
Texas State University Recruiting
San Marcos, Texas, United States, 78666
Contact: Stacy D. Hunter, PhD    512-245-8046    yogabpstudy@gmail.com   
Sponsors and Collaborators
Texas State University
Investigators
Layout table for investigator information
Study Chair: Monica Gonzales Texas State University IRB
Tracking Information
First Submitted Date  ICMJE March 6, 2018
First Posted Date  ICMJE June 20, 2019
Last Update Posted Date March 30, 2021
Actual Study Start Date  ICMJE April 17, 2018
Estimated Primary Completion Date October 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 19, 2019) 		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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 19, 2019)
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effects of Hot Yoga on Vascular Function
Official Title  ICMJE The Effects of Bikram (Hot) Yoga on Vascular Health in Hypertensive Adults
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Hypertension
  • Elevated Blood Pressure
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: 90-minute Hot Yoga Classes
    This group will complete 3, 90-minute hot yoga classes weekly for 12 weeks.
    Intervention: Behavioral: Hot Yoga
  • Experimental: 60-minute Hot Yoga Classes
    This group will complete 3, 60-minute hot yoga classes weekly for 12 weeks.
    Intervention: Behavioral: Hot Yoga
  • No Intervention: Control
    This group will maintain their current physical activity for 12 weeks.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 19, 2019) 		169
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2022
Estimated Primary Completion Date October 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Stacy D. Hunter, PhD 512-245-8046 s_h393@txstate.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03993184
Other Study ID Numbers  ICMJE 2018381
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Texas State University
Study Sponsor  ICMJE Texas State University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Monica Gonzales Texas State University IRB
PRS Account Texas State University
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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