Effect of Yoga Training on Cardiovascular, Autonomic, Mental Health and Cognitive Parameters in Hypertensive Patients: a Randomized Controlled Clinical Trial (Hypertension and Yoga Study)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Blood Pressure
研究概览
简要总结
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%.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
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.
干预措施: YOGA (Behavioral)
CONTROL
The CG will not receive any intervention during the study and, like the GY subjects, will be instructed not to change their routines.
干预措施: Control (Behavioral)
结局指标
主要结局
Blood Pressure
时间窗: Baseline, 8 and 16 weeks
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).
次要结局
- Anxiety(Baseline, 8 and 16 weeks)
- Sleep Quality(Baseline, 8 and 16 weeks)
- Quality of life(Baseline, 8 and 16 weeks)
- Cognitive function(Baseline, 8 and 16 weeks)
- Depressive Symptoms(Baseline, 8 and 16 weeks)
- Stress(Baseline, 8 and 16 weeks)
- Attention and inhibitory response capacity(Baseline, 8 and 16 weeks)
- Health related quality of life(Baseline, 8 and 16 weeks)
研究者
Aline Mendes Gerage
PhD
Universidade Federal de Santa Catarina