IJCS | Volume 31, Nº6, November / December 2018

620 Silva et al. Virtual rehabilitation for individuals with heart disease Int J Cardiovasc Sci. 2018;31(6)619-629 Original Article allowing real-time three-dimensional movement. 11 The videogames that adopt physical interaction with the user are called “exergames” 12,13 and provide body motion as a form of exercise. 14 Physical exercise influences physical fitness, whose components include flexibility, muscle strength, cardiorespiratory endurance and body composition. 15 The studies by Mandic et al., 16 and Calegari et al., 17 have shown that the regular practice of physical activity has favorable effects on the body composition and functional capacity of individuals with CVD. However, whether the VR intervention as a physical exercise modality has benefits similar to those of the cardiovascular rehabilitation process remains controversial. This study hypothesized that, after implementing conventional and VR cardiac rehabilitation, individuals have similar improvement in body composition and functional capacity. This study aimed at comparing the effects of conventional and VR cardiac rehabilitation on the body composition and functional capacity of individuals with CVD. In addition, food frequency and blood glucose levels were assessed. Methods Ethical aspects The individuals included in this study were informed about all the procedures and provided written informed consent to participate. This study was approved by the Ethics Committee of the institution (CAAE: 62437816.4.0000.5515) andabides by theCONEP resolution 466/2012. The registration of this randomized clinical trial can be found at Clinicaltrials.gov (NCT03169387). Sample characterization This is a parallel group randomized clinical trial conducted at the physical therapy clinic of the Oeste Paulista University (UNOESTE), in the city of Presidente Prudente, São Paulo, Brazil, from February to October 2017. The sample comprised 27 individuals divided into two groups: a conventional rehabilitation group (CRG) and a virtual reality rehabilitation group (VRG). Based on sample calculation, each group had at least 12 individuals, using the study by Pimenta et al. (2013) 18 as reference. Fat-free mass was used, with standard deviation of 4.02, difference to be detected of 3.8 for the two-tail hypothesis test, power of 80%, and significance level of 5%. Figure 1 shows the flow diagram of the participants in every phase of the study, in accordance with the recommendations of the CONSORT Statement. 19 The random allocation sequence was generated by a researcher without previous contact with the participants by use of the Microsoft Office Excel ® program, at an allocation ratio of 1:1. The study included individuals over the age of 45 years, of both sexes, with CVD (coronary heart disease, postoperative period of coronary artery by-pass grafting, acute myocardial infarction, systemic arterial hypertension, diabetes mellitus). The inclusion criteria were as follows: hemodynamic stability (systolic blood pressure < 200 mmHg and diastolic blood pressure < 110 mmHg at rest, absence of angina, controlled arrhythmias, and resting heart rate < 120 beats per minute); 20 absence of arteriopathy and muscle or orthopedic changes; and no supervised physical activity in the previous 30 days. The exclusion criteria were as follows: decompensations (circumstances posing a risk to individual integrity) during the training protocol; lack of adaptation to the protocol; and participation frequency lower than 75%. Experimental design Participants underwent an initial evaluation to detect comorbidities, to establish the diagnosis, to collect the clinical history and medications used, and to measure the anthropometric variables. The following parameters were assessed before the intervention and eight weeks after that: body composition; waist circumference; food frequency; functional capacity; and blood glucose levels. Anthropometric variables Weight (in kilograms) was measured with a WELMY W300 ® scale (accuracy to the nearest 100 g), with the individual barefoot wearing light and comfortable clothes. Height (in meters) was measured with a Sanny ® stadiometer (accuracy to the nearest 0.1 cm), with the individual barefoot, standing with his/her back to the height rule, feet together, head positioned in the Frankfurt plane, and the measuring rod lowered to the individual’s head. Bodymass index (BMI) was calculated based on weight and height (weight/height 2 ). Body composition Body composition was the study’s primary outcome, and body fat percentage was defined as the primary variable. Body composition was assessed by use of