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Recruiting NCT07125313

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

No phase Interventional Hypertension

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: YOGA, Control.
Who it may be relevant to
Registry conditions: Hypertension. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Brazil
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Effect of Yoga Training on Cardiovascular, Autonomic, Mental Health and Cognitive Parameters in Hypertensive Patients: a Randomized Controlled Clinical Trial (Hypertension and Yoga Study)

Overview

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%.

Interventions

  • Behavioral YOGA
    The participants randomized to the yoga group will perform 16 weeks of yoga training, three times/week for 60 minutes.
  • Behavioral Control
    Usual care

Primary outcome measures

  • Blood Pressure [Time frame: Baseline, 8 and 16 weeks]
Secondary outcome measures (8)
  • Quality of life [Time frame: Baseline, 8 and 16 weeks]
  • Cognitive function [Time frame: Baseline, 8 and 16 weeks]
  • Sleep Quality [Time frame: Baseline, 8 and 16 weeks]
  • Depressive Symptoms [Time frame: Baseline, 8 and 16 weeks]
  • Stress [Time frame: Baseline, 8 and 16 weeks]
  • Attention and inhibitory response capacity [Time frame: Baseline, 8 and 16 weeks]
  • Health related quality of life [Time frame: Baseline, 8 and 16 weeks]
  • Anxiety [Time frame: Baseline, 8 and 16 weeks]

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Brazil · 1 center
  • Universidade Federal de Santa Catarina — Florianópolis

Identifiers

NCT: NCT07125313 · HY STUDY

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗