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

Abstract

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.