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

NCT07125313 | Not Yet Recruiting

• 1 other identifier: HY STUDY
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Blood Pressure

  Clinical BP (Systolic and Diastolic) will be measured using an oscillometric device (Omron HEM 742) (OMRON Healthcare, Kyoto, Japan), according to current recommendations, while ambulatory BP will be assessed over 24 hours using a DynaMAPA device (Cardios), both in accordance with current recommendations (FEITOSA et al., 2024).

  Baseline, 8 and 16 weeks

Secondary Outcomes (8)

• Quality of life

  Baseline, 8 and 16 weeks

• Cognitive function

  Baseline, 8 and 16 weeks

• Sleep Quality

  Baseline, 8 and 16 weeks

• Depressive Symptoms

  Baseline, 8 and 16 weeks

• Stress

  Baseline, 8 and 16 weeks

Study Arms (2)

YOGA

EXPERIMENTAL

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.

Behavioral: YOGA

CONTROL

OTHER

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

Behavioral: Control

Interventions

YOGA BEHAVIORAL

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

YOGA

Control BEHAVIORAL

Usual care

CONTROL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Universidade Federal de Santa Catarina: lead

Study Sites (1)

Universidade Federal de Santa Catarina

Florianópolis, Santa Catarina, 88040-900, Brazil

Location

MeSH Terms

Conditions

Hypertension

Interventions

Yoga

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Exercise Movement Techniques; Physical Therapy Modalities

Central Study Contacts

Aline Gerage, PhD

CONTACT

554837218554; alinegerage@yahoo.com.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: July 23, 2025
• First Posted: August 15, 2025
• Study Start: August 11, 2025
• Primary Completion (Estimated): December 20, 2026
• Study Completion (Estimated): December 20, 2026
• Last Updated: August 15, 2025

Record last verified: 2025-08

Locations

BR (1)