Effect of a virtual cardiac rehabilitation program on patients with hypertension: A randomized trial

Introduction: Hypertension is among the main primary factors for the cause of death from cardiovascular diseases. Among the treatments for hypertension, physical exercise has stood out. However, the adherence of patients with hypertension to the practice of physical exercises is low, and thus strategies such as virtual rehabilitation may be beneficial, in addition to increasing adherence. Objective: This study aimed to evaluate the effect of a virtual cardiovascular rehabilitation (VCR) program on arterial blood pressure, physical conditioning and the quality of life of patients with hypertension. Methods: This is a randomized clinical trial with 59 patients with hypertension, divided into three groups: conventional cardiac rehabilitation (CCR), VCR and control (CO). Before and after the intervention period the patients were submitted to anthropometric data (BMI, body mass index), vital data (SBP, systolic blood pressure; DBP, diastolic blood pressure), quality of life (SF-36 questionnaire), respiratory muscle strength (MIP, maximum inspiratory pressure; MEP, maximum expiratory pressure) and functional capacity (6-MWT, six-minute walk test) assessment. Both VCR and CCR groups underwent aerobic training. Results: VCR protocol increased functional capacity (p < 0.001), expiratory muscle strength (p < 0.002), and quality of life in the domains in relation to limitation of physical (p < 0.018), emotional aspects (p < 0.019), social aspects (p < 0.042), and mental health (p < 0.002) when baseline and post-intervention were compared. Conclusion: The VCR program is an effective treatment strategy for improving the physical capacity and quality of life of patients with hypertension.


Introduction
Hypertension is a multifactorial clinical condition characterized by sustained high arterial blood pressure levels. 1 Studies have shown that hypertension may increase from 594 million adults in 1975 to 1.56 billion adults in 2025, mainly in developing countries.2 In addition, there are several complications arising from hypertension (e.g., acute myocardial infarction, stroke, and kidney failure), which are among the main causes of morbidity and mortality, with significant consequences for public health.3 Thus, the control of hypertension is an important step both to prevent and to reduce these complications.3 Among the various treatments for hypertension, non-pharmacological treatment has become important, mainly because it facilitates hemodynamic and autonomic adjustments, which help in controlling arterial blood pressure and, consequently, the quality of life of patients.4 Thus, physical exercise has been an effective strategy because it produces a series of physiological responses (e.g., reduced sympathetic autonomic system activity and reduced peripheral vascular resistance), and it has proven to be important when associated with conventional pharmacological treatment.4 According to the World Health Organization, cardiac rehabilitation (CR) "is defined as the sum of activities required to favorably influence the underlying cause of the disease and to provide the best possible physical, mental, and social conditions, so that the patients may, by their own efforts, preserve or resume, as normally as possible, a place in the community".200 kg capacity and accurate to 100 g, placed on a flat surface and calibrated for each weighing.BMI was evaluated according to the reference values previously described in the literature. 16,17  For measurements of diastolic blood pressure (DBP) and systolic blood pressure (SBP), participants were seated at rest for 10 min, and the mid-upper arm circumference was evaluated using a calibrated aneroid sphygmomanometer coupled to an appropriately sized brachial blood pressure cuff placed on the arm.All

Statistical analysis
Analyses related to the effect of cardiac rehabilitation programs were performed in the per-protocol population.
This population considers all eligible patients treated

Results
This study began with 72 participants.After randomization, 23 were allocated to the CO group, 25 to the CCR group, and 24 to the VCR group.During the study, 13 subjects did not complete, which was finished with 59 participants (20 in the CO group, 20 in the CCR group, and 19 in the VCR group) (Figure 1).Furthermore, HR values were controlled in the study participants (Table 1).Regarding clinical variable, the present study demonstrated a significant reduction (p < 0.029) of systolic blood pressure from baseline to post-intervention values in the CCR group, as demonstrated in Table 2 (moment baseline vs. post by ANOVA).In addition, MEP values increased significantly in both CCR (p < 0.001) and VCR (p < 0.002) groups when baseline and post-intervention were compared (Table 2).VCR group also presented a significant increase (p < 0.001) in the distance walked on the 6-MWT when baseline and post-intervention were compared (Table 2).
In addition to clinical variable, the Table 2 shows a significant improvement in quality of life domains

Conclusion
The present study concludes that VCR may be an effective treatment strategy for patients with hypertension, mainly for improving quality of life and functional capacity.However, in relation to the control of arterial blood pressure no effect was found after this intervention, and more studies are necessary for this indication.

Discussion
The current study showed that VCR was efficient in improving the quality of life of patients with hypertension, especially in relation to limitation of physical and emotional aspects, social aspects and mental health.In The allocation was concealed by using consecutively sealed, numbered, opaque envelopes.Due to the characteristic of the treatment, which included physical exercise, neither the therapist nor the participants could be blinded.The groups in which the participants were randomized were the following: control (CO, n = 23), patients with hypertension that did not perform any type of physical activity; CCR (n = 25), patients with hypertension undergoing conventional cardiac rehabilitation; VCR (n = 24), patients with hypertension undergoing virtual cardiac rehabilitation.The primary outcomes evaluated were arterial blood pressure, functional capacity, and quality of live; the secondary outcomes were heart rate, maximum inspiratory pressure (MIP), maximum expiratory pressure (MEP), and body mass index (BMI).The evaluation consisted of anamnesis and information about when the hypertension arose (history of the current and previous illness), symptoms, quality of life, pharmacotherapy use, level of physical activity, and type of occupation.capacity, vital signs, and quality of life were evaluated, as described below.Height and body mass were measured in order to calculate the BMI.Weight was measured using a portable stadiometer (Seca 217, CA, USA), in which the barefoot subjects were positioned upright, with arms hanging beside the body, and the heels, back, and head touching the wooden column.Body weight was measured in kilograms on a platform scale (Filizola, São Paulo, Brazil),

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measurements were made on the left arm at the level of the heart.The average of two readings was recorded as the blood pressure value for the individual.Standard recommended procedures were used for the selection of the position and size of the sphygmomanometers used.18Measurements of MIP and MEP, which are indicators of respiratory muscle strength, were taken while the individual was seated, using an analogic Fisioter Mov.2021;34:e34126 4 manovacuometer (Wika, SP, Brazil) with a range of -120 to +120 cmH in a scale intervals of 4 cmH 2 O, with a silicone adapter for manual maneuvering and a mouthpiece with an orifice at the distal end that was sealed during inhaling, thereby facilitating the exact time to be measured.19For evaluation of physical capacity, we used the sixminute walking test (6-MWT) in accordance with the guidelines of the American Thoracic Society.20The test was conducted on a 30-meter indoor walkway, whose length was marked every 5 m with non-slip-colored tape glued to the floor.Before and immediately after the test, heart rate (HR), SBP, DBP, and rating of perceived exertion scores of each subject were measured and recorded.Using a wristwatch, the resting HR was measured for 60 seconds, by palpation at the radial artery.This measurement was preceded by at least 5 minutes of seated rest.The quality of life was evaluated via the SF-36 (Short Form Health Survey) questionnaire, which consisted of 36 items, in which all but one of the items were assigned to one of the eight health domains covering various aspects of physical and mental health: physical functioning (10 items), physical role functioning (4 items), bodily pain (2 items), general health perceptions (5 items), vitality, (5 items), social role functioning (2 items), emotional role functioning (3 items), and mental health (5 items).21The highest scores in each domain represent better health status, with scores ranging from 0 to 100: the closest to 0, the least favorable to health status, and the closest to 100, the most favorable one.During the administration of the questionnaire, the questions were read and clarified by the evaluator and answered by the participants.The administration of the entire questionnaire, as well as the scoring, was done using the SF36+ app.All measurements previously described were taken between 7:30 and 10:00 AM, with the participants instructed to avoid coffee, alcohol, nicotine, and exercise for at least two hours before the assessment.After baseline assessments, participants of VCR and CCR groups started training, and on the two days after the last session a new assessment was carried.In the CO group, reevaluation was done similarly to the intervention groups.Blind investigators have taken all outcomes assessments to the interventions.For interventions, CCR group participants performed three 50-minute sessions of aerobic exercise in treadmill (Movement RT250, Brazil) per week, on non-consecutive days, for 12 weeks, and a total of 36 sessions.VCR group performed two 70-minute sessions per week on nonconsecutive days, for 15 weeks, and a total volume of 30 sessions.VCR´s sessions consisted of six supervised aerobic exercises: three for the upper limbs and three for the lower limbs, selected from the video games Nintendo Wii (Hula Hoop, Footing, and Rhythmic Boxeo) and Xbox 360 (Run the Word-Broadway, Wall Breaker, and Legs-100%).For CCR group, at the beginning, during every 10 minutes, and at the end of each session, SBP, DBP, HR, and the perceived exertion rating were checked.In the VCR group, these variables were measured before the session and after each of the six exercises.In the CO group, participants were instructed to perform only simple activities associated with daily living.Both CCR and VCR groups exercised at 60 -70% HR (target zone), calculated in accordance with the Karvonen formula, 22 and measured continuously with a portable HR monitor (Polar, NY, USA).The CCR group started the training program with 50 minutes of activity divided as follows: 5 minutes warm-up, 40 minutes of training in the target zone and final 5 minutes of cool down.While the VCR group performed the same period for warm-up and cool down, the training was maintained at 60 minutes.Both interventions were performed between 7:00 and 10:00 AM.After the study, patients in the CO group were invited to participate in the CR program.For the present study, the sample size was calculated based on a previous study.23 This study was chosen for the sample calculation, due to the similarity with the analyzed variables and the experimental protocols of the present study.The calculation was performed using the Gpower version 3.1.9.2 program, in which a significance level of 0.05, a power of 80%, and a correlation coefficient of 0.8 for all variables were adopted.Based on the means obtained in the aforementioned study, which found an aerobic training-induced decrease in SBP values (147.3 ± 6.9 mmHg) compared to control group control (155.4 ± 8.3 mmHg), the calculations were performed, which took into account the primary outcomes and demonstrated the need for an "n" of at least 14 individuals in each group.Considering the possibility of dropouts, we decided to increase the number of study participants in relation to the estimated sample size.
limitation of physical aspects (p < 0.003), pain (p < 0.013), vitality (p < 0.001), social aspects (p < 0.003), limitation of emotional aspects (p < 0.001), and mental health (p < 0.009) in CCR group when baseline and postintervention were compared (moment baseline vs. post by ANOVA).VCR group also significantly improved the limitation of physical aspects (p < 0.001), social aspects (p < 0.003) and limitation of emotional aspects (p < 0.001) domains when baseline and post-intervention were compared.Interestingly, this study found a significant improvement in CO group in relation to limitation of physical aspects (p < 0.001) and limitation by emotional aspects domains (p < 0.001) when baseline and postintervention were compared ( addition, this rehabilitation cardiac protocol improved the functional capacity and expiratory muscle strength when compared to baseline values.A reduction in SPB and DBP values found after CCR demonstrates that this protocol may be more efficient in controlling blood pressure and, consequently, the cardiovascular risk than VCR.In addition, a study found that a blood pressure reduction of 5/2 mm Hg reduced the first incidence of fatal and non-fatal stroke by 29%.24Although most studies have shown a reduction in arterial blood pressure after aerobic training, most of them were performed with young adults, unlike the present study that was conducted in hypertensive elderly with higher blood pressure levels.25 Furthermore, studies have shown that greater the number of weekly sessions, greater the reduction in SBP and DPB levels.26 Thus, we suggest that if the number of sessions was greater than three per week, we could find a reduction in SBP and DBP values in the VCR group.Both VCR and CCR increased the quality of life of patients with hypertension in several domains evaluated.Another study had already shown an improvement in quality of life of subjects with cardiac disease after a CCR program of eight weeks composed of muscle strength training and 20-30 minutes of daily aerobic exercise.27 However, this was the first study to find this effect by VCR, demonstrating that this protocol may be effective in improving the quality of life of hypertensive patients.When evaluating physical capacity by 6-MWT, we found a significant improvement only in VCR compared to baseline values.The 6-MWT proved to be a reliable test for assessing functional capacity in a phase II/III CR population.28 Despite the baseline levels found in the 6-MWT being very low in relation to the other groups, it was possible to verify the importance of the VCR in improving this parameter.This finding was verified by the interaction between group and time.Furthermore, in our study the improvement in functional capacity found by the VCR was similar to that found by the CCR in a study conducted by Bellet et al. 29Besides the results of the 6-MWT, our study showed that both VCR and CCR improved expiratory muscle strength (assessed by MEP) when compared to their

Table 1 -
Characterization of participants of the study

Table 2 -
Clinical variables and quality of life of study participants No significant difference between groups were found in the post hoc test in the baseline comparisons.