Yoga in Altering Mechanistic Outcomes in Hypertension

T

Texas State University

Status

Enrolling

Conditions

Hypertension

Treatments

Behavioral: Slow, deep breathing
Behavioral: Control breathing
Behavioral: Yoga

Study type

Interventional

Funder types

Other

Identifiers

NCT05158205
7988

Details and patient eligibility

About

The proposed study will assess the effects of yoga postures and slow, deep breathing in altering oxidative stress, vascular function, and blood pressure.

Full 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.

Enrollment

90 estimated patients

Sex

All

Ages

30 to 60 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

90 participants in 2 patient groups

Yoga postures or slow, deep breathing
Experimental group
Treatment:
Behavioral: Yoga
Behavioral: Slow, deep breathing
Control
Sham Comparator group
Treatment:
Behavioral: Control breathing

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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