The incorporation of the Pilates method of exercise differs from routine structured physical exercise protocols, as it is based on a mind-body association. A thought process used positively to execute a particular movement with specific breathing patterns, generating kinesthetic awareness aids in reducing mental stress, anxiety, enhancing sleep, and a sense of well-being. Changes in body movement as a whole with concentration, synchronized breathing, and precise control of the body part to be moved with precision in a rhythmic manner creates an environment of the movement pattern and ability to identify the muscle being recruited to perform the desired movement. ^{10 – 14} Pilates can be performed either on the mat or using Pilates equipment using one’s body weight. ^{15 , 16} It has been effectively reviewed on various health-related parameters such as body composition, ¹⁷ stress urinary incontinence, ¹⁸ and breast cancer survivors’ health-related quality of life, ¹⁹ falls, and physical fitness in the elderly. ^{20 – 22}

Following the principles of control, breathing, concentration, flow of movement, centering, and Pilates have often been used to improve physical function and muscle conditioning. The benefits of Mat Pilates being a feasible, novel, and recreational mode of exercise implementing cost-effective resources of mats has been reported in different populations such as multiple sclerosis, Parkinson’s disease, older adults, and low back pain. ^{23 – 26} Energy expenditure (EE), blood lactate levels, oxygen uptake (VO2 uptake), and low cardiovascular stress (including heart rate and blood pressure) have been observed with the implementation of Mat Pilates when compared to the Reformer Pilates method (which utilizes larger equipment) in healthy young female adults. ²⁷ Although the above studies report beneficial effects of Mat Pilates on a spectrum of disease conditions, there is a scarcity of studies reporting the effects of mat Pilates on variations in peripheral and central blood pressure parameters in individuals with systemic hypertension. In addition, structural and hemodynamic changes within the cardiac chambers have rarely been reported in relation to this exercise method in hypertensive individuals.

The primary and secondary objectives of this trial were to study the effects of mat Pilates on.

Primary outcomes: 1.

Resting blood pressure (systolic and diastolic blood pressure) (mm of Hg)

Secondary outcomes: 4.

Health related quality of life (HrQoL)

Hypotheses:

Null hypothesis: This trial hypothesizes that mat Pilates will not have a beneficial reduction in arterial blood pressure and will not improve health-related quality of life in participants with systemic hypertension.

Alternate hypothesis: Mat Pilates has a positive effect on reducing resting blood pressure, including central pulse pressure and central systolic pressure. In addition, the application of mat Pilates will improve health-related quality of life in individuals with systemic hypertension.

Considering the fewer studies reported, this trial will be a two-arm, single-blinded, prospective randomized controlled trial (RCT) aimed at evaluating the efficacy of a 12 weeks, mat Pilates program on changes in resting and central blood pressures (central pulse pressure and central systolic pressure) in a total of 120 participants.

Participants will be screened in the outpatient departments of General Medicine and Cardiology, Kasturba Hospital, Manipal.

Mat Pilates exercises will be administered and supervised in the outpatient department of the Physiotherapy and Health Performance Laboratory, Kasturba Hospital Manipal.

Participants aged between 30 and 60 years diagnosed with systemic arterial hypertension with optimal blood pressure control on regular antihypertensive therapy will be recruited for this clinical trial.

Inclusion criteria: 1.

Stage 1 (systolic blood pressure > 130–139 mmHg or diastolic blood pressure > 80–89 mmHg) and Stage 2 (systolic blood pressure >140–159 mmHg or diastolic blood pressure > 90–99 mmHg) hypertensive individuals.

Exclusion criteria: 1.

Stage 2 hypertension: systolic blood pressure >160 mmHg and diastolic blood pressure >100 mmHg.

The study protocol was approved by the Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee, Kasturba Hospital, Manipal (an associate hospital of the Manipal Academy of Higher Education, Manipal, Karnataka, India) (registration number: ECR/146/Inst/KA/2013/RR-19) to recruit participants (IEC: 596/2019. Date of approval September 11, 2019). The trial has been registered under the Clinical Trials Registry of India (CTRI/2021/07/035002. Registered on July 20, 2021, http://ctri.nic.in.) This clinical trial adheres to the guidelines and ethical principles for medical research of the Declaration of Helsinki involving human participants.

Any protocol-related amendments during the trial tenure will be communicated to the Institutional Research Committee, Institutional Ethics Committee, Directorate of Research, Manipal Academy of Higher Education, and Clinical Trial Registry of India. Written informed consent will be obtained from all the participants. Stakeholders and committees will receive key findings regarding the implementation of mind-body association exercises as a measure of lifestyle modification in individuals with systemic hypertension. Post-trial ancillary care will be provided to participants in the control group after completion of the clinical trial period if they wish to undergo intervention group exercises.

The calculated sample size was based on the primary outcome of resting BP considering a level of significance (α) of 0.05, with a power of 80%. With an anticipated standardized difference of four standard deviations of the primary outcome, the estimated minimal clinically important difference (MCID) at 2 mmHg after a period of 12 weeks (at baseline and after 12th week) in both the control and experimental groups, a sample of 44 participants in each group was calculated. Considering an attrition of 20%, the sample size was calculated to be 55 participants and rounded up to 60 participants per group owing to block randomization.

A random number sequence will be generated using computerized random number generator. Participants will be randomized to the control and intervention groups with 1:1 allocation and a block size of 6 consisting of ten participants in each block per group. The allocation sequence will be generated using computer-generated randomized allocation software. Using the sequentially numbered opaque envelope (SNOSE) method, allocation concealment is performed. Of the 120 participants, 60 will be allocated to the control or experimental group.

This RCT will be a single-blind study. Random allocation to both groups will be performed by a health professional who is not a member of the investigator team. At the completion of twelve weeks, a blinded outcome assessor will assess set outcomes of the respective groups.

Prior permission was sought from the copyright publishers for the administration of the World Health Organization (WHO) BREF Health-Related Quality of Life Questionnaire in two languages. Participants will be screened for eligibility based on their diagnosis and stage of systemic hypertension. Eligible participants will then be familiarized with the study using the participant information sheet, and willing participants will be recruited after obtaining their written informed consent. Preliminary screening will be implemented and written informed consent will be obtained at the outpatient clinic of the Department of Medicine, Kasturba Hospital, Manipal, Karnataka, India.

Baseline assessment of three resting blood pressure measurements in supine lying position with a rest period of one minute in between measurements will be recorded at the same time of the day (10 am). Participants will be instructed to abstain from consumption of alcohol, caffeine, or any caffeine-containing beverage 10 hours prior to the exercise testing session. The values of central systolic blood pressure, central pulse pressure, and mean arterial pressure will be measured by the principal investigator. Left ventricular ejection fraction (LVEF) and left ventricular end-diastolic volume will be measured by a professional expert trained in echocardiography. Including demographic data, the baseline scores of the WHO BREF HRQOL, anthropometric measurements, and exercise stress testing will be measured. This time point will be denoted as T0. Baseline assessment of eligible participants will be performed at the Health Performance Laboratory, Department of Physiotherapy, Clinical Teaching Center, and echocardiographic measurements will be recorded at the Department of Cardiology, Kasturba Hospital, Manipal, India. The participants will then be sequentially block randomized into two groups by a blinded investigator.

Participants in the experimental group will undergo a two-week supervised Mat Pilates program, after which exercises will be performed at home for 10 weeks. An exercise instruction manual for the mat Pilates program will be provided to every participant at the end of 2 weeks. A weekly telephonic, supervised monitoring call will be implemented to address and record any issues related to compliance, adherence, or adverse events. In addition, they will be advised to follow standard care with the recommended salt intake of 2.4 g) or sodium chloride (6 g) per day and regular physical activity of 3-5 days per week. ²⁸

The control group will receive standard care and a prescribed antihypertensive drug regimen. After 12 weeks, the outcomes will be reassessed and recorded (T1) by a blinded investigator. Adherence will be set at 75% of the total number of sessions (27 of 36 sessions). A flowchart of the procedure is shown in Figure 1. The schedule of participant enrolment, interventions, and assessments has been provided ( Figure 2) according to the Standard Protocol Items: Recommendations for Intervention Trials (SPIRIT) guidelines. ²⁹

The Mat Pilates exercise program will consist of 11 different exercises with a warm-up of 15 min and cool down for 10 min. Three sessions per week of 60 minutes each will be implemented ( Table 1). The exercises will be familiarized with, taught, and monitored by a certified mat Pilates instructor.

Adverse events will be recorded and reported every week during telephonic monitoring. Participants will be questioned regarding any major or minor events that may have occurred during the course of their exercise program tenure. The reporting of events, if any, will be implemented by the Institutional Ethics committee for further proceedings.

The measuring equipment used will be standardized and calibrated periodically every 3 months. The Diamond ^® Aneroid (BPDL-250 Dial Deluxe) pressure monitor with field calibration feature will be used to measure the resting blood pressure. Mats of six feet by four feet with one and a half inch thickness will be used to perform mat Pilates exercises. The Microlife ^® WatchBP Office Central, which is an oscillometric calibrated blood pressure device, will measure central blood pressure parameters non-invasively using an arm cuff. Additionally, this device could detect any ongoing atrial fibrillation in the participant. The balance protocol for exercise stress testing will be performed on a Stayfit ^® testing treadmill.

Primary

Resting blood pressure values (systolic/diastolic) in mmHg will be assessed at T0 and T1. Central blood pressure variables (systolic/diastolic/pulse) will be assessed non-invasively pre- and post-intervention, indicating target organ perfusion and perfusion pressure in the central organs (cerebrum, myocardium, kidneys, and liver). Changes observed in central blood pressure with regular exercise would aid in identifying any progression or reduction in target organ health in systemic hypertension.

Secondary

Health-related quality of life (HrQOL) in the mental, physical, and psychosocial domains will be assessed at T0 and T1, indicating any variation in the function of daily living in individuals with systemic hypertension. Two-dimensional echocardiographic findings (LVEF, left ventricular end diastolic volume) as secondary outcomes will aid in identifying any structural, ventricular wall stress-related changes in the myocardial wall before and after 12 weeks of the mat Pilates program versus standard care.

Data will be statistically analyzed using the Jamovi software. Descriptive analysis will be used to interpret demographics, intention-to-treat analysis will be used for missing data, and subgroup analysis based on age will be used to interpret age-wise changes in blood pressure. The Kolmogorov–Smirnov test will be used as a test of normality, and repeated-measures analysis of variance (ANOVA) will be used to analyze the within-group and between-group differences and pre- and post-differences at T0 and T1. Analysis of covariance (ANCOVA) will be used to analyze the contribution of covariates in the study. All analyses of recorded data will comply with the standards of data analysis for randomized controlled trials that include the analysis of missing data due to attrition.