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

NCT ID: NCT07125313

Last Updated: 2025-08-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-11
• Study Completion Date: 2026-12-20

Brief Summary

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%.

Conditions

Hypertension

Study Design

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

Study Groups

YOGA

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.

Group Type: EXPERIMENTAL

YOGA

Intervention Type: BEHAVIORAL

The participants randomized to the yoga group will perform 16 weeks of yoga training, three times/week for 60 minutes.

CONTROL

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

Group Type: OTHER

Control

Intervention Type: BEHAVIORAL

Usual care

Interventions

YOGA

The participants randomized to the yoga group will perform 16 weeks of yoga training, three times/week for 60 minutes.

Intervention Type: BEHAVIORAL

Control

Usual care

Intervention Type: BEHAVIORAL

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidade Federal de Santa Catarina

OTHER

Sponsor Role: lead

Responsible Party

Aline Mendes Gerage

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Universidade Federal de Santa Catarina

Florianópolis, Santa Catarina, Brazil

Countries

Brazil

Central Contacts

Aline Gerage, PhD

Role: CONTACT

alinegerage@yahoo.com.br

554837218554

Facility Contacts

Aline Gerage, PhD

Role: primary

alinegerage@yahoo.com.br

4899934799

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

HY STUDY

Identifier Type: -

Identifier Source: org_study_id