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

ConditionHypertension
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversidade Federal de Santa Catarina

About this trial

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%.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults or elderly individuals

>= 40 years

Both sexes

Diagnosis of hypertension controlled by up to three medications

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • YOGA

    Behavioral

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

  • Control

    Behavioral

    Usual care

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: YOGAExperimental treatment 1 intervention
Group B: CONTROLOther 1 intervention

Trial outcomes

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).

Time frame
Baseline, 8 and 16 weeks

Secondary outcomes

1

Quality of life

Quality of life will be assessed using the EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) (EUROQOL, 2025; VAN ROTTERDAM, HENSLEY, HAZELTON, 2021). This questionnaire was introduced by the EuroQol Group in 2009. This questionnaire assessed quality of life and health perception, consisting of a page with an objective questionnaire and another page with a visual analog scale. The objective questionnaire is divided into five aspects: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each aspect has five levels ranging from "no problem" (1) to "extreme problem" (5), thus, higher scores denote a worse quality of life. The scale allows participants to record their overall health perception on a vertical scale, from 0 (worst health) to 100 (best health) (BAGATTINI, 2015).

Time frame
Baseline, 8 and 16 weeks
2

Cognitive function

Cognitive function will be assessed using the Montreal Cognitive Assessment (MoCA) questionnaire, which comprises eight domains. The maximum score is 30 points, corresponding to the best cognitive ability (HOBSON, 2015).

Time frame
Baseline, 8 and 16 weeks
3

Sleep Quality

Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI-BR) (BERTOLAZI et al., 2011; BUYSSE, 1989). It consists of a questionnaire composed of 19 self-administered questions, followed by five questions to be answered by the bed partner, if available. This questionnaire is composed of seven domains: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction (BERTOLAZI et al., 2011). Minimum: 0 points → excellent sleep and Maximum: 21 points → very poor sleep.

Time frame
Baseline, 8 and 16 weeks
4

Depressive Symptoms

Depressive symptoms will be assessed using the Patient Health Questionnaire-9 (PHQ-9) (APA, 2000; SANTOS et al., 2013), containing nine questions that assess the presence of symptoms of a major depressive episode, described in the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV): depressed mood, anhedonia, problems with sleep, fatigue or lack of energy, changes in appetite or weight, feelings of guilt or worthlessness, trouble concentrating, feeling sluggish or restless, and suicidal thoughts (APA, 2000). The PHQ9 assesses the frequency of symptoms in the past two weeks, assessed on a scale with the possible responses of "none of the time," "several days," "more than half the days," and "almost every day" (SANTOS et al., 2013). Values can range from 0 to 27, with higher values indicating a greater presence of depressive symptoms.

Time frame
Baseline, 8 and 16 weeks

Other outcomes

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