- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02924012
Active Video Game and Potential to Cause Post-exercise Hypotension
Energy Demand in a Video Game Active Session and Potencial to Promove Post Exercise Hypotension in Hypertensive Women
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Hypertension Diagnosis Be postmenopausal Display overweight or obesity grade I (BMI between 25 and 34.9 kg / m2) Not practicing systematic physical exercise for at least three months Not carry labyrinthitis
Exclusion Criteria:
Start any antihypertensive treatment during the study period Have difficulty to perform the AVG games Take more than four weeks to complete all experimental procedures
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: active video game
An active game session lasting 40 minutes
|
The session lasted 40 minutes.
The participants held an active video game session.
At the end they were monitored for 60 minutes at rest.
Other Names:
|
OTHER: sedentary video game
An sedentary game session lasting 40 minutes
|
The session lasted 40 minutes.
The participants held an sedentary video game session, using the traditional joystick.
At the end they were monitored for 60 minutes at rest.
Other Names:
|
OTHER: walking
An walking lasting 40 minutes
|
The session lasted 40 minutes.
The participants held a walk using the treadmill.
At the end they were monitored for 60 minutes at rest.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Blood Pressure
Time Frame: Sixty minutes after AVG, SVG or WAL
|
Before the Start All such sessions, as requested Participants Were one Stay 15 Minutes Resting and sitting.
After this period was checked PA Home.
New Outlets Were measures immediately At the end of the session and experimental one every 15 minutes during hum 60 Minutes Recovery Period, with as sitting voluntary period During this ALL.
These measures Were performed hair 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).
Were Made Three pressure sockets one measure and considered each The two values Closer.
|
Sixty minutes after AVG, SVG or WAL
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quantifying the movements
Time Frame: Forty minutes duration AVG, SVG or WAL
|
It used an accelerometer 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
|
Forty minutes duration AVG, SVG or WAL
|
Cardiac autonomic modulation
Time Frame: Sixty minutes after AVG, SVG or WAL
|
Immediately after each measurement of BP was assessed by MAC HR variability, using a monitor label 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).
|
Sixty minutes after AVG, SVG or WAL
|
Enjoyment scale
Time Frame: Sixty minutes after AVG, SVG or WAL
|
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.
|
Sixty minutes after AVG, SVG or WAL
|
Energy expenditure
Time Frame: Forty minutes duration AVG, SVG or WAL
|
Was made by gas analysis through the analyzer portable lung gases K4b2 (Cosmed Copyritgh ©, Rome, Italy) validated the study by McLaughlin et al.
This equipment enables verification in each breath, respiratory parameters, measuring the oxygen consumption (VO2) and carbon dioxide production during exercise
|
Forty minutes duration AVG, SVG or WAL
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- VGA-HYP
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hypertension
-
National Taiwan University Hospital Hsin-Chu BranchRecruitingHypertension,Essential | Hypertension, MaskedTaiwan
-
BayerCompletedPrimary HypertensionChina
-
University of Alabama at BirminghamTroy UniversityCompletedHypertension | Hypertension, Resistant to Conventional Therapy | Uncontrolled Hypertension | Hypertension, White CoatUnited States
-
Columbia UniversityAgency for Healthcare Research and Quality (AHRQ)Active, not recruitingWhite Coat Hypertension | Hypertension,EssentialUnited States
-
Addpharma Inc.Completed
-
Universidade Federal de Santa MariaCompletedHealthy Volunteers | Hypertension, EssentialBrazil
-
Sheffield Teaching Hospitals NHS Foundation TrustUniversity of SheffieldCompletedIdiopathic Pulmonary Arterial Hypertension | Chronic Thromboembolic Pulmonary HypertensionUnited Kingdom
-
China Academy of Chinese Medical SciencesGuang'anmen Hospital of China Academy of Chinese Medical SciencesCompletedHypertension, Resistant to Conventional Therapy | Primary HypertensionChina
-
Sulaiman AlRajhi CollegesUnknownHypertension, Essential | β-hydroxybutyrate
Clinical Trials on video game active
-
Brigham Young UniversityCompleted
-
Bard CollegeUniversity of Texas at AustinCompleted
-
Professor Fernando Figueira Integral Medicine InstituteUniversidade Estadual da ParaibaCompletedPhysical Activity | Overweight and Obesity | Cardiovascular Risk FactorBrazil
-
Baylor College of MedicineNational Cancer Institute (NCI)CompletedPhysical Inactivity in ChildrenUnited States
-
Dokuz Eylul UniversityCompletedCoronary Artery DiseaseTurkey
-
Mor NahumHadassah Medical Organization; Ludwig-Maximilians - University of Munich; Riga...RecruitingMajor Depressive DisorderGermany, Israel, Latvia
-
The University of Texas Medical Branch, GalvestonCompletedBreast Cancer | Physical ActivityUnited States
-
Ryerson UniversityCompleted
-
Universidad Nacional de Educación a DistanciaCompleted
-
The University of Texas Medical Branch, GalvestonM.D. Anderson Cancer Center; National Institute on Aging (NIA)CompletedBreast Cancer | Physical ActivityUnited States