Yoga in Altering Mechanistic Outcomes in Hypertension

NCT ID: NCT05158205

Last Updated: 2025-04-11

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-11
• Study Completion Date: 2024-11-30

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.

Conditions

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Yoga postures or slow, deep breathing

Group Type: EXPERIMENTAL

Yoga

Intervention Type: BEHAVIORAL

12-week yoga intervention in which 60-minute classes are completed at Texas State University 3 times per week

Slow, deep breathing

Intervention Type: BEHAVIORAL

12-week home-based intervention in which 5 weekly 20-minute breathing sessions are completed

Control

Group Type: SHAM_COMPARATOR

Control breathing

Intervention Type: BEHAVIORAL

12-week home-based intervention in which 5 weekly 20-minute breathing sessions are completed

Interventions

Yoga

12-week yoga intervention in which 60-minute classes are completed at Texas State University 3 times per week

Intervention Type: BEHAVIORAL

Slow, deep breathing

12-week home-based intervention in which 5 weekly 20-minute breathing sessions are completed

Intervention Type: BEHAVIORAL

Control breathing

12-week home-based intervention in which 5 weekly 20-minute breathing sessions are completed

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Texas State University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Cardiovascular Physiology Laboratory-Texas State University

San Marcos, Texas, United States

Countries

United States

Other Identifiers

7988

Identifier Type: -

Identifier Source: org_study_id