Study Stopped
The project period ended prior to the completion of full enrollment.
Yoga in Altering Mechanistic Outcomes in Hypertension
Yoga Postures and Slow, Deep Breathing in Altering Mechanistic Outcomes in Hypertension
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable hypertension
Started Jul 2022
Typical duration for not_applicable hypertension
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 8, 2021
CompletedFirst Posted
Study publicly available on registry
December 15, 2021
CompletedStudy Start
First participant enrolled
July 11, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2024
CompletedApril 11, 2025
April 1, 2025
2.4 years
November 8, 2021
April 8, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
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.
Baseline and week 4, 8, and 12 measurements
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.
Baseline and week 4, 8, and 12 measurements
Secondary Outcomes (3)
Change in 24-hour blood pressure
Baseline and week 4, 8, and 12 measurements
Change in flow-mediated dilation
Baseline and week 4, 8, and 12 measurements
Change in microvascular endothelial function/thermal hyperemia
Baseline and week 4, 8, and 12 measurements
Study Arms (2)
Yoga postures or slow, deep breathing
EXPERIMENTALControl
SHAM COMPARATORInterventions
12-week yoga intervention in which 60-minute classes are completed at Texas State University 3 times per week
12-week home-based intervention in which 5 weekly 20-minute breathing sessions are completed
12-week home-based intervention in which 5 weekly 20-minute breathing sessions are completed
Eligibility Criteria
You may not qualify if:
- 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;
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cardiovascular Physiology Laboratory-Texas State University
San Marcos, Texas, 78666, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- A sham control condition will be implemented if randomized to the control group.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 8, 2021
First Posted
December 15, 2021
Study Start
July 11, 2022
Primary Completion
November 30, 2024
Study Completion
November 30, 2024
Last Updated
April 11, 2025
Record last verified: 2025-04