ClinicalTrials.gg
CompletedNCT02924012Updated Oct 5, 2016

Active Video Game and Potential to Cause Post-exercise Hypotension

An interventional study of video game active and sedentary video game in Hypertension, sponsored by Federal University of Paraíba. Completed. Open to female participants aged 47 Years to 68 Years. Per ClinicalTrials.gov, last updated 2016-10-05.

Sponsored by Federal University of Paraíba · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
14
Allocation
Randomized
Ages
47 Years to 68 Years
Sex
Female
01

Study summary

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).

Read the 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.

02

Conditions studied

  • Hypertension

Keywords

  • post exercise hypotension
  • exercise
  • video games
03

In context

Hypertension

6,114 studies on the registry are indexed under Hypertension; 912 are open to participants now.

This study's enrollment of 14 is below the median of 100 across 4,575 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

Federal University of Paraíba is the lead sponsor of 73 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
47 Years to 68 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Hypertension Diagnosis Be Display overweight or obesity grade I ( between 25 and 34.9 kg / m2) Not practicing systematic physical exercise for at least three months Not carry labyrinthitis

Exclusion criteria

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

Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
14 participants (actual)

Study arms

  • Experimental
    active video game

    An active game session lasting 40 minutes

    Other: video game active

  • Other
    sedentary video game

    An sedentary game session lasting 40 minutes

    Other: sedentary video game

  • Other
    walking

    An walking lasting 40 minutes

    Other: walking

Interventions

  • Othervideo game active

    The session lasted 40 minutes. The participants held an active video game session. At the end they were monitored for 60 minutes at rest.

    Also known as: AVG

  • Othersedentary video game

    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.

    Also known as: SVG

  • Otherwalking

    The session lasted 40 minutes. The participants held a walk using the treadmill. At the end they were monitored for 60 minutes at rest.

    Also known as: WAL

06

What researchers measure

Primary outcomes

  1. Blood Pressure

    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.

    Time frame: Sixty minutes after AVG, SVG or WAL

Secondary outcomes

  1. Quantifying the movements

    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

    Time frame: Forty minutes duration AVG, SVG or WAL

  2. Cardiac autonomic modulation

    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).

    Time frame: Sixty minutes after AVG, SVG or WAL

  3. 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.

    Time frame: Sixty minutes after AVG, SVG or WAL

  4. Energy expenditure

    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

    Time frame: Forty minutes duration AVG, SVG or WAL

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of May 2015, a primary completion of Aug 2015 and a completion of Oct 2015. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 3, 2016
First posted
Oct 5, 2016
Start
May 2015
Primary completionActual
Aug 2015
CompletionActual
Oct 2015
Last update
Oct 5, 2016
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 5, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02924012
Lead sponsor
Federal University of Paraíba
Responsible party
Taís Feitosa da Silva (Master, Federal University of Paraíba) — Principal investigator
First posted
Oct 5, 2016
Start date
May 2015
Primary completion
Aug 2015
Completion
Oct 2015
Last update
Oct 5, 2016

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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