Mat Pilates 对全身性高血压患者静息血压和与健康相关的生活质量的疗效:单中心单盲随机对照试验的研究方案

N. Prabhu, G. A. Maiya, Vaishali K, Shivashankara Kn
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摘要

背景 全身性高血压是一种全球性的非传染性疾病,因此亟需通过改变生活方式(包括运动)来降低升高的血压。瑜伽普拉提是一种可行的身心协调运动形式,可在资源有限的情况下带来益处。目标 该随机对照试验旨在评估 Mat Pilates 对全身性高血压患者静息血压和健康相关生活质量的疗效。方法 一项双臂、单盲、整组随机对照试验将招募 120 名参与者,分为对照组和实验组(1:1 的比例)。实验组将进行为期 12 周的 Mat Pilates 训练,对照组将进行为期 12 周的标准护理训练。试验前后将测量静息血压和中心血压、与健康相关的生活质量以及超声心动图参数。我们假设普拉提可能无益于降低高血压患者的静息血压。重复测量方差分析(ANOVA)将检验 Mat Pilates 对各种结果的组内和组间影响。伦理和传播 试验已获得马尼帕尔健康职业学院、马尼帕尔高等教育学院、卡斯图尔巴医学院和卡斯图尔巴医院机构研究委员会的批准。将获得所有参与者的书面知情同意。所有利益相关者和委员会将就身心联合运动作为系统性高血压患者生活方式调整措施的主要研究结果进行交流。试验登记 印度临床试验登记处:CTRI/2021/07/035002.注册日期为 2021 年 7 月 20 日,http://ctri.nic.in。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Efficacy of Mat Pilates on the resting blood pressure and health related quality of life in individuals with systemic hypertension versus standard care: study protocol for a single centered single blinded randomized controlled trial
Background Systemic hypertension is a global non-communicable disease that creates an essential need for alternate forms of lifestyle modifications, including exercise, to lower elevated blood pressure. Mat Pilates, a feasible form of mind-body coordinated exercise, may provide benefits with limited resources. Objective This randomized controlled trial aimed to assess the efficacy of Mat Pilates on resting blood pressure and health-related quality of life in individuals with systemic hypertension. Methods A two-arm, single-blinded, block randomized controlled trial will be recruited with120 participants into control and experimental groups (1:1 ratio). Mat Pilates will be administered to the experimental group and standard care to the control group for 12 weeks. Resting and central blood pressure, health-related quality of life, and echocardiographic parameters will be measured before and after the trial. We hypothesized that Pilates may not be beneficial in lowering resting blood pressure in hypertensive patients. A repeated-measures analysis of variance (ANOVA) will test the within- and between-group effects of Mat Pilates on various outcomes. Ethics and Dissemination The trial was approved by the Institutional Research Committee, Manipal College of Health Professions, Manipal Academy of Higher Education, Kasturba Medical College, and Kasturba Hospital Institutional Ethics Committee, Manipal. Written informed consent will be obtained from all the participants. All stakeholders and committees will communicate key findings regarding the implementation of mind-body association exercises as a measure of lifestyle modification in individuals with systemic hypertension. Trial registration Clinical Trials Registry of India: CTRI/2021/07/035002. Registered on July 20, 2021, http://ctri.nic.in.
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