Clinical trial NCT05158205: Yoga in Altering Mechanistic Outcomes in Hypertension
Official title: Yoga Postures and Slow, Deep Breathing in Altering Mechanistic Outcomes in Hypertension
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hypertension
Lead sponsor: Texas State University
Sponsor class: OTHER
First posted: 2021-12-15
Enrollment: 30
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 30-60 years) with elevated blood pressure or stage I hypertension will be recruited and randomized to 12 weeks of yoga, video-based breathing, or app-based breathing 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 app-based breathing 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.

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;
* 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;
* currently smoking or having quit within the last 6 months;
* Raynaud's disease, peripheral vascular disease, or arteritis.

Primary outcomes:
measure: Change in peripheral blood mononuclear cell reactive oxygen species
timeFrame: Baseline and week 4, 8, and 12 measurements
measure: Change in peripheral blood mononuclear cell NADPH oxidase cell NADPH oxidase enzyme activity
timeFrame: Baseline and week 4, 8, and 12 measurements
Secondary outcomes:
measure: Change in 24-hour blood pressure
timeFrame: Baseline and week 4, 8, and 12 measurements
measure: Change in flow-mediated dilation
timeFrame: Baseline and week 4, 8, and 12 measurements
measure: Change in microvascular endothelial function/thermal hyperemia
timeFrame: Baseline and week 4, 8, and 12 measurements
Other outcomes:
Locations:
city: San Marcos
country: United States
facility: Cardiovascular Physiology Laboratory-Texas State University
state: Texas
Study officials:
References: