Hypertension Clinical Trial
Official title:
Energy Demand in a Video Game Active Session and Potencial to Promove Post Exercise Hypotension in Hypertensive Women
The aim of this study was to determine the energy demand and the potential to promote reduce blood pressure of an active video game (AVG). Fourteen hypertensive (56.4 ± 7.5 years) held a session AVG and traditional sedentary video game sessions (SVG) and walk (WAL), as negative and positive controls, in order determined randomly. During the sessions, they were observed oxygen consumption and energy expenditure (EE). Blood pressure (BP) and cardiac autonomic modulation (CAM) were measured at rest and every 15 minutes of a 60 minute period of recovery activities. It was also applied a rating scale of pleasure (enjoyment scale).
Volunteers: In a previous pilot study, seven women who had systolic blood pressure (SBP) of
resting 128.9 ± 9.4 mmHg obtained a reduction to 116.9 ± 7.0 mmHg 60 minutes after a workout
with AVG. These data resulted in an effect size of 1.05. Adopting an α error of 0.05 and
statistical power of 0.95, estimated a minimum sample size of 12 volunteers. effectively
participated in the study 14 hypertensive women aged between 47 and 68 years (56.4 ± 7.5
years). In addition to the diagnosis of hypertension, they should perform with pressure
values of at least 130/90 mmHg and no greater than 160/110 mmHg in measurements made in the
days before the study and on the day of data collection. They should still be postmenopausal
women, being overweight or obesity grade I (BMI between 25 and 34.9 kg / m2), not be
practicing systematic physical exercise for at least three months and not be suffering from
labyrinthitis. They would be excluded from the study volunteers who initiate any
antihypertensive treatment during the study period, presented difficulties to perform the
AVG games or take him more than four weeks to complete all experimental procedures.
The research project was approved by the Research Ethics Committee of the Health Science
Center - UFPB under the nº0621 / 14 protocol. After informed about all the procedures, the
volunteers signed a Consent and Informed (IC) according to the resolution 466/12 of the
National Health Council of Brazil.
Study design: the volunteers held an AVG session, an internal control session composed of
sedentary video game (SVG) and an external control session consists of a walking exercise
(WAL) with a minimum of 48 hours between sessions and order determined randomly. In all
sessions, during activities, they were instrumented with portable gas analyzer for measuring
energy expenditure (EE) accelerometer to quantify performed movements and heart rate monitor
to evaluate the behavior of heart rate (HR). Blood pressure measurements (BP) and cardiac
autonomic modulation (CAM) were performed at rest and every 15 minutes a period 60 minutes
of recovery activities. In these same times it was applied a rating scale of pleasure in
activities (enjoyment scale) (Figure 1).
Pre experimental procedures: prior to the experimental sessions, blood pressure
measurements, physical activity and blood collection were made to characterize the
participants. Personal information on the drugs used and collected and they were given a
list containing rich foods and medicines caffeine could not be ingested 24 before each
experimental session.
Adaptation activities: the participants underwent three sessions of adaptation and learning
the handling of active and sedentary games and walking on a treadmill. The sessions lasted
10 to 40 minutes, with an interval of 48 hours between sessions and at least 72 hours
between the last session of adaptation and the first test session. The intensity adopted in
these sessions was free, but participants were encouraged to achieve moderate intensity on
the treadmill exercise (60% to 85% of maximum heart rate). They were also taught to respond
to the subjective perception questionnaires effort and enjoyment scale.
Video active game: the console was the Xbox 360 with Kinect sensor (Foxconn®, New Taipei,
China) and the game used was Dance Central (Harmonix Music Systems - Microsoft Games
Studios). The difficulty level of the game was adopted the beginner, since the participants
had no previous experience with AVG. In the game used, bodily movements are similar to dance
steps with the use of different songs from pop style referring to the 1970, 1980, 1990 and
2000. The session lasted 40 minutes.
Video game sedentary: we used the Dance Dance Revolution® (SSD Company Ltd., Shiga, Japan)
for Playstation 2® (San Mateo, CA, USA), where the practitioner simulated synchronized
dances of similar songs to those used in gyms, however using the joystick traditionally
known, so that remained seated throughout the session. The duration of the game was 40
minutes.
walking exercise: the participants performed a walking session on a treadmill (Moviment,
Brudden Ltda, São Paulo, Brazil) lasting 40 minutes and previously prescribed intensity
between 60% and 80% of maximum heart rate.
Accelerometry: an accelerometer used was brand Actigraph® GT3 X (Pensacola, USA) for
evaluating the acceleration of the body, calibrated according to the manufacturer's
specifications. The adopted time interval was 60 seconds and output data expressed as mean
counts per minute. The unit was set at waist height, the right hand by a strap of elastic
and adjustable buckle. At the end of the records, data were transferred to a computer and
analyzed using the SAS 9.2 software (SAS Institute Inc., Cary, NC 25513). The adopted
referêcia values were 0-99 counts / min-1, considered sedentary activity, 100-1951 counts /
min-1, light activity, 1952-5724 counts / min-1 was moderate activity and from 5725 counts /
min-1, seen vigorous activity, according Freedson et al (113) Energy demand: it was made by
gas analysis through the analyzer portable lung gases K4b2 (Cosmed Copyritgh ©, Rome, Italy)
validated the study by McLaughlin et al (114). This equipment enables verification in each
breath, respiratory parameters, measuring the oxygen consumption (VO2) and carbon dioxide
production during exercise. The device was calibrated according to the manufacturer's
recommendations. The variables measured by this instrument were the DE and VO2. The
measurements were performed at rest (for five minutes) and during experimental sessions.
Heart rate and perceived exertion: HR was measured using a heart rate monitor brand Polar
RS800CX model (Polar ElectroOy, Kempele, Finland). The measurements were made after 10
minutes at rest and every 5 minutes Durantes exercises. In the same times that HR was
measured, the Subjective Perception Scale of Borg effort (Noble and Borg et al, 1983), with
scale 6-20 points, was presented to the participants and asked who said they had their
feelings of stress.
Enjoyment Scale: This scale has been validated for use in the adult population according to
Graves et al. (2008). It consists of 18 items that assessed the level of pleasure /
enjoyment from levels ranging from "I like" to "I hate" in that the higher the sum of these
points, pleasure / enjoyment the activity performed provided. This scale was presented to
participants at the beginning of each study session and the same to answer the end of each
study session.
Blood pressure: before the start of each session, participants were asked to stay 15 minutes
at rest and sitting. After this period was found resting BP. Further measures were taken
immediately at the end of the experimental session and every 15 minutes during a 60-minute
recovery period, the volunteers seated throughout this period. These measurements were
performed by the oscillometric method with the use of ambulatory monitoring apparatus PA
(DYNAMAPA) following the V Brazilian Guidelines on BP ambulatory monitoring (ABPM) (ALESSI,
A; BRANDÃO, A.;. PIERIN et al, 2005). three pressure taps were made for each measure and
considered the two closest values.
Cardiac Autonomic Modulation (CAM): Immediately after each measurement of BP, we evaluated
the MAC through the HR variability, using a monitor brand Polar RS800CX (PolarElectroOy,
Kempele, Finland). The volunteers were seated and the record was made for a minimum of 10
minutes. Data were transferred to a computer provided with software of the same manufacturer
and then transferred to the Kubios HRV software, version 2.0 (University of Kuopio,
Finland). Data were analyzed in the time domain, being considered the average (RRM) and the
standard deviation of the individual intervals RR (SDNN), the root mean square of successive
differences between adjacent RR (RMSSD) and the percentage of successive differences between
RR intervals greater than 50 ms (pNN50). In the frequency domain, they were considered low
frequency bands (0:04 to 00:15 Hz) (LF) and high frequency (0.15 to 0.4 Hz) (AF). It was
also adopted the low ratio frequency / high frequency as sympathetic-vagal balance (LF /
HF).
Statistical analysis: Data are mean and standard error of the mean. the Shapiro-Wilk tests
were used to verify the normality and Levene to check homogeneity. One-way ANOVA was used to
compare the resting values. For comparisons between measurements during and after the
experimental sessions, it adopted the two-way ANOVA test. Data were analyzed using the
GraphPad Prism 6.0 software (GraphPad, San Diego, CA, USA), a significance of p <0.05.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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