Effect of Yoga Training on Cardiovascular and Mental Health Parameters in Hypertensive Patients (HY)

Universidade Federal de Santa Catarina

Status: Not yet enrolling

Conditions: Hypertension

Treatments: Behavioral: Control; Behavioral: YOGA

Study type: Interventional

Funder types: Other

Identifiers

NCT07125313

HY STUDY

Details and patient eligibility

About

The objective of this study will be to analyze the effect of 16 weeks of Yoga training on cardiovascular, autonomic, mental health, and cognitive parameters in hypertensive individuals. This is a randomized, controlled clinical trial to be conducted with adults and elderly (40 years or older), of both sexes, diagnosed with High Blood Pressure (HBP), who will be randomized into two groups: Yoga Group (YG) and Control Group (CG). The YG will undergo a Yoga training program involving breathing techniques, mobility, physical postures, relaxation, and meditation for 16 weeks. In the first eight weeks (phase 1), three supervised weekly sessions will be held. In the last eight weeks of the study (phase 2), the training will consist of three supervised weekly sessions and the delivery of an asynchronous video lesson, with the weekly frequency then increasing (from three to four sessions per week). The video lesson will be available on a digital platform. Before, after eight weeks, and after 16 weeks, cardiovascular, autonomic, mental and cognitive health parameters will be assessed. Furthermore, the biomarkers Brain-Derived Neurotrophic Factor (BDNF), serotonin, and nitric oxide will be analyzed at different assessment times of the study, as well as biochemical profile tests (glucose, total cholesterol, among others), functional capacity tests, and body composition. This project is expected to contribute to the literature by better elucidating the effects of Yoga on the cardiovascular, mental, and cognitive health of hypertensive individuals. The SPSS (21.0) statistical package will be used for data analysis. After confirming the appropriate assumptions, generalized estimating equations will be used, followed by the Bonferroni post hoc test, with a significance level of 5%.

Enrollment: 70 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults or elderly individuals
• >= 40 years
• Both sexes
• Diagnosis of hypertension controlled by up to three medications
• Who do not present high cardiovascular risk
• Who have not engaged in a physical exercise program in the six months prior to the start of the study will participate in the study.

Exclusion criteria

• Adherence of less than 75% of training sessions
• Diagnosis of other diseases during the study
• Adherence to another physical exercise program
• Change in the class and/or dose of antihypertensive medication during the study
• Worsening of the disease (resting systolic blood pressure (BP) > 180 mmHg).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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70 participants in 2 patient groups

YOGA

Experimental group

Description:

The GY will receive an intervention involving Yoga Training (TY), which will be divided into two phases: Phase 1 (first eight weeks), which will be supervised, with three weekly sessions lasting 60 minutes, and Phase 2 (the following eight weeks), which will consist of three supervised sessions per week and the delivery of an asynchronous video lesson via a digital platform, with an incremental session of one session per week. Classes will also be 60 minutes long. The supervised sessions will take place at the UFSC CDS rehabilitation center. TY sessions will follow the following structure: breathing techniques (Pranayama), warm-up (Pavana Muktasana), physical postures in standing, sitting, and lying positions (Asanas), and relaxation (Yoganidrá). The postures will be prescribed by holding time in seconds (30 to 40 seconds), number of sets, and rest between sets. Each session will include beginner, intermediate, and advanced postures.

Treatment:

Behavioral: YOGA

CONTROL

Other group

Description:

The CG will not receive any intervention during the study and, like the GY subjects, will be instructed not to change their routines.

Treatment:

Behavioral: Control