Essential Hypertension
Conditions
Interventions
This is a prospective, randomized, controlled, two-arm, non-blinded clinical trial. A total of 69 people who meet the eligibility criteria will be probabilistically allocated to one or the other inter
Sponsors
Instituto do Coração do Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo
Instituto do Coração do Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo
Eligibility
Age
65 Years to No maximum
Inclusion criteria
Inclusion criteria: The inclusion criteria are: age 65 years or older; diagnosis of stage 1 or 2 hypertension for more than 6 months; brachial blood pressure measured in the office of less than or equal to 140/90 mmHg under stable antihypertensive medication for at least 2 months; ability to participate in light to moderate physical activity; and provision of free and informed written consent
Exclusion criteria
Exclusion criteria: Exclusion criteria include persistent or permanent atrial fibrillation; insulin-dependent diabetes mellitus; chronic kidney disease with estimated glomerular filtration rate <30 mL/min/1.73 m²; previous stroke; heart failure with left ventricular ejection fraction <40%; recent myocardial infarction (<6 months); symptomatic coronary artery disease; complex ventricular arrhythmias; current smoking; severe cognitive impairment or dementia; musculoskeletal or peripheral vascular conditions limiting exercise; body mass index >35 kg/m²; secondary hypertension; or regular yoga practice within 90 days before study entry
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is the difference between groups in the variation of brachial systolic blood pressure (SBP) from the beginning of the study to week 12. A mean difference of at least 5 mmHg in the variation of brachial systolic blood pressure (SBP) between groups is expected after 12 weeks. Brachial blood pressure will be measured according to international guidelines using a validated automatic oscillometric device. Measurements will be taken in a quiet room after at least 5 minutes of seated rest, with the back supported, feet flat on the floor, and arm supported at heart level. An appropriately sized cuff, based on arm circumference, will be used. Three consecutive measurements will be taken at 1-2 minute intervals, and the average of the last two readings will be used for analysis | — |
Secondary
| Measure | Time frame |
|---|---|
| Arterial Stiffness: A reduction in carotid-femoral pulse wave velocity (cfPWV) of approximately 0.5 m/s is expected in the yoga intervention group after 12 weeks. Arterial stiffness will be assessed using validated non-invasive devices based on oscillometric technology. Carotid-femoral pulse wave velocity (cfPWV) will be used as a reference measure of aortic stiffness, calculated as the ratio between the superficial distance between the measurement sites in the carotid and femoral arteries and the pulse wave transit time;Endothelial Function: A minimum increase of 1 percentage point in brachial artery flow-mediated dilation (FMD) is expected after 12 weeks of intervention in the Yoga group. Endothelial function will be assessed by brachial artery flow-mediated dilation (FMD) using high-resolution ultrasound, following established methodological guidelines. After measuring the baseline arterial diameter, a pneumatic cuff will be placed on the forearm and inflated to a suprasystolic pressure for 5 minutes. Changes in arterial diameter induced by reactive hyperemia will be continuously recorded after cuff deflation. Brachial artery flow-mediated dilation (FMD) will be expressed as the percentage change from baseline diameter;Functional Capacity: A minimum increase of 25 meters in the total distance covered by individuals in the Yoga intervention group is expected after 12 weeks in the 6-minute walk test (6MWT). Functional capacity will be assessed using the 6-minute walk test (6MWT). The test will be performed on a treadmill with a fixed incline of 0%, in an air-conditioned environment. Before the start of the test, participants will receive standardized instructions on the procedure and on the use of the Borg Rating of Perceived Exertion (RPE) scale (6–20). The goal will be to maintain perceived exertion between 11 (“relatively easy”) and 13 (“slightly tiring”), a range considered compatible with submaximal effort and safe for the studied population. During the test, | — |
Countries
Brazil
Contacts
Public ContactGuilherme Guimaraes
Instituto do Coração do Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo
Outcome results
None listed