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Yoga in Altering Mechanistic Outcomes in Hypertension

Primary Purpose

Hypertension

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Yoga
Slow, deep breathing
Control breathing
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

40 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Exclusion Criteria:

  • pregnancy (tests will be administered to all premenopausal females at initial screening and follow up visits);
  • having taken blood pressure or statin medications within the past 3 months (statins have been demonstrated to reduce oxidative stress);
  • infection (viral or other) within the past 4 weeks;
  • having adrenal or endocrine tumors (these could impact blood pressure);
  • renal disease defined as an estimate glomerular filtration rate (eGFR) of less than 60 (creatinine will be tested at initial screening and eGFR will be calculated);
  • hyperaldosteronism;
  • prior myocardial infarction;
  • known coronary heart disease;
  • personal history of stroke;
  • heart failure;
  • cardiac arrhythmias;
  • chronic obstructive pulmonary disease, asthma, or other airflow obstructions;
  • recent chest pain or dyspnea;
  • orthopedic limitations that preclude the execution of yoga postures;
  • current insulin dependence; xvi) chronic inflammatory conditions (e.g., rheumatoid arthritis, lupus, HIV/AIDS, ulcerative colitis, or Crohn's disease);
  • currently taking steroid or other anti-inflammatory medication;
  • currently undergoing chemotherapy or radiation;
  • having practiced yoga or slow, deep breathing at least once weekly within the past 6 months; or
  • currently smoking or having quit within the last 6 months.

Sites / Locations

  • Cardiovascular Physiology Laboratory-Texas State UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Yoga postures or slow, deep breathing

Control

Arm Description

Outcomes

Primary Outcome Measures

Change in peripheral blood mononuclear cell reactive oxygen species
Blood draws will be performed at baseline and at weeks 4, 8, and 12 during the study after randomization and analyzed for free radicals after white blood cells are separated from whole blood.
Change in peripheral blood mononuclear cell NADPH oxidase cell NADPH oxidase enzyme activity
A portion of the white blood cells isolated from a whole blood sample will be frozen and later analyzed for enzyme activity. This will be completed for blood samples obtained at baseline and weeks 4, 8, and 12.

Secondary Outcome Measures

Change in 24-hour blood pressure
An automated cuff will be worn for 24 hours while the devices takes automatic measurements every 30 minutes.
Change in flow-mediated dilation
A cuff will placed around the forearm while an ultrasound probe is held on the upper arm to obtain a brachial artery image. The forearm cuff will be inflated for 5 minutes, then ultrasound images of the upper arm will be obtained for 3 minutes after cuff deflation.
Change in microvascular endothelial function/thermal hyperemia
A small probe will be secured on the forearm and gradually heated for 45 minutes.

Full Information

First Posted
November 8, 2021
Last Updated
October 25, 2022
Sponsor
Texas State University
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1. Study Identification

Unique Protocol Identification Number
NCT05158205
Brief Title
Yoga in Altering Mechanistic Outcomes in Hypertension
Official Title
Yoga Postures and Slow, Deep Breathing in Altering Mechanistic Outcomes in Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
July 11, 2022 (Actual)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
November 30, 2023 (Anticipated)

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
Yes

5. Study Description

Brief Summary
The proposed study will assess the effects of yoga postures and slow, deep breathing in altering oxidative stress, vascular function, and blood pressure.
Detailed Description
The purpose of this study is to determine the mechanism by which yoga lowers blood pressure in hypertensive adults. Free radicals and enzyme activity will be analyzed from isolated immune cells and blood pressure and vascular health will be assessed at baseline and at weeks 4, 8, and 12 during the interventions or control conditions. Sedentary adults (ages 40-60 years) with elevated blood pressure or stage I hypertension will be recruited and randomized to 12 weeks of yoga, slow, deep breathing, or waitlist control conditions. Yoga classes will be completed 3 times weekly at Texas State University and slow, deep breathing interventions will be completed at home 5 times weekly. Participants assigned to the waitlist/sham control group will also complete 5- 20-minute breathing exercises per week at home before being re-randomization at week 12. Three testing sessions will be completed at the beginning of the study: 1) familiarization and screening for elevated blood pressure or hypertension and other exclusion criteria; 2) confirmation of elevated blood pressure or hypertension via addition seated blood pressure measurements and 24-hour ambulatory blood pressure and 3-day physical activity monitoring; and 3) blood marker assessment and endothelial function measurements. All outcomes will be measured at baseline and at 4-week intervals throughout the 12-week data collection period in all 3 groups. At each follow up visit after randomization, testing will be completed over the course of 2 sessions: 1) ambulatory blood pressure monitor and physical activity monitoring and 2) blood marker and endothelial function measurements. At the end of the waitlist sham/control period, waitlisted participants will be rerandomized to yoga or slow, deep breathing interventions. Once re-randomized, participants in each group will complete follow up testing 4,8, and 12 weeks into their respective interventions.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
A sham control condition will be implemented if randomized to the control group.
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Yoga postures or slow, deep breathing
Arm Type
Experimental
Arm Title
Control
Arm Type
Sham Comparator
Intervention Type
Behavioral
Intervention Name(s)
Yoga
Intervention Description
12-week yoga intervention in which 60-minute classes are completed at Texas State University 3 times per week
Intervention Type
Behavioral
Intervention Name(s)
Slow, deep breathing
Intervention Description
12-week home-based intervention in which 5 weekly 20-minute breathing sessions are completed
Intervention Type
Behavioral
Intervention Name(s)
Control breathing
Intervention Description
12-week home-based intervention in which 5 weekly 20-minute breathing sessions are completed
Primary Outcome Measure Information:
Title
Change in peripheral blood mononuclear cell reactive oxygen species
Description
Blood draws will be performed at baseline and at weeks 4, 8, and 12 during the study after randomization and analyzed for free radicals after white blood cells are separated from whole blood.
Time Frame
Baseline and week 4, 8, and 12 measurements
Title
Change in peripheral blood mononuclear cell NADPH oxidase cell NADPH oxidase enzyme activity
Description
A portion of the white blood cells isolated from a whole blood sample will be frozen and later analyzed for enzyme activity. This will be completed for blood samples obtained at baseline and weeks 4, 8, and 12.
Time Frame
Baseline and week 4, 8, and 12 measurements
Secondary Outcome Measure Information:
Title
Change in 24-hour blood pressure
Description
An automated cuff will be worn for 24 hours while the devices takes automatic measurements every 30 minutes.
Time Frame
Baseline and week 4, 8, and 12 measurements
Title
Change in flow-mediated dilation
Description
A cuff will placed around the forearm while an ultrasound probe is held on the upper arm to obtain a brachial artery image. The forearm cuff will be inflated for 5 minutes, then ultrasound images of the upper arm will be obtained for 3 minutes after cuff deflation.
Time Frame
Baseline and week 4, 8, and 12 measurements
Title
Change in microvascular endothelial function/thermal hyperemia
Description
A small probe will be secured on the forearm and gradually heated for 45 minutes.
Time Frame
Baseline and week 4, 8, and 12 measurements

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Exclusion Criteria: pregnancy (tests will be administered to all premenopausal females at initial screening and follow up visits); having taken blood pressure or statin medications within the past 3 months (statins have been demonstrated to reduce oxidative stress); infection (viral or other) within the past 4 weeks; having adrenal or endocrine tumors (these could impact blood pressure); renal disease defined as an estimate glomerular filtration rate (eGFR) of less than 60 (creatinine will be tested at initial screening and eGFR will be calculated); hyperaldosteronism; prior myocardial infarction; known coronary heart disease; personal history of stroke; heart failure; cardiac arrhythmias; chronic obstructive pulmonary disease, asthma, or other airflow obstructions; recent chest pain or dyspnea; orthopedic limitations that preclude the execution of yoga postures; current insulin dependence; xvi) chronic inflammatory conditions (e.g., rheumatoid arthritis, lupus, HIV/AIDS, ulcerative colitis, or Crohn's disease); currently taking steroid or other anti-inflammatory medication; currently undergoing chemotherapy or radiation; having practiced yoga or slow, deep breathing at least once weekly within the past 6 months; or currently smoking or having quit within the last 6 months.
Facility Information:
Facility Name
Cardiovascular Physiology Laboratory-Texas State University
City
San Marcos
State/Province
Texas
ZIP/Postal Code
78666
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stacy D. Hunter, PhD
Phone
512-245-8046
Email
s_h393@txstate.edu
Ext
Hunter
Email
s_h393@txstate.edu
First Name & Middle Initial & Last Name & Degree
Stacy D Hunter, PhD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Yoga in Altering Mechanistic Outcomes in Hypertension

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