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HypertensionNCT02578485

Single Session of Active Video Game Promotes Post Exercise Hypotension in Middle-aged Hypertensive

A study testing AVideogame, SVideogame and EMIntensity in people with Hypertension, run by Federal University of Paraíba.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Background: The active video game (VGA) it has been studied how much to the physiological factors of your practice. The objective was to determine whether an AVG session promotes post-exercise hypotension (PEH) similar to walking exercise. Read more about this study

Who is it for?
Ages 45 to 59 years
Conditions the study is for
Hypertension
What is being tested?
AVideogame, SVideogame and EMIntensity
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
15 participants
Where
No sites listed yet
Study dates
Jul 2013to Dec 2013
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 to 59 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • be hypertensive;
  • age between 45 and 59 years old;
  • not perform regular exercise;
  • not use of beta-blockers drugs and calcium channel blockers;
  • not be affected by labyrinthitis
  • women be not in menopause;
  • be not practitioners of VGA.

Who cannot join

  • modifying the antihypertensive treatment during treatment;
  • Not have developed the ability to play during the adaptation period.

About this study

Background: The active video game (VGA) it has been studied how much to the physiological factors of your practice. The objective was to determine whether an AVG session promotes post-exercise hypotension (PEH) similar to walking exercise. Methods: Fifteen hypertensive (49.0 ± 1.6 years), both genders performed five randomized sessions, lasting 60 minutes: 1) AVG, 2) sedentary video game (SVG), 3) walk treadmill with moderate intensity (WMI), 4) walk treadmill with similar intensity to VGA (WGI), and 5) control without exercise (CON). Intensity was determined by Heart rate (HR) and Perceived Exertion (PE). Blood pressure (BP) and cardiac autonomic modulation (CAM) measurements were taken at rest and every 10 minutes post exercise for 60 minutes.

Read the detailed description

Volunteers of study Participated of this study 15 hypertensive patients of both genders, five of them men. All participants were obese grade I and were using drug therapy. Were adopted as inclusion criteria: 1) be hypertensive; 2) age between 45 and 59 years old and 3) not perform regular exercise; 4) not use of beta-blockers drugs and calcium channel blockers; 5) not be affected by labyrinthitis; 6) women be not in menopause, and, 4) be not practitioners of VGA. Already as exclusion criteria: 1) modifying the antihypertensive treatment during treatment; and 2) Not have developed the ability to play during the adaptation period.

This study was approved by the Ethics in Research Committee of the University Hospital Lauro Wanderley under protocol nº 201/11 and after subjects having been cleared up all the procedures of the study, the subjects were asked to sign the Term of Free and Informed Consent (TFIC) according to the Resolution 196/96 of the National Health Council.

Study Design The subjects were submitted to five protocols lasting 60 minutes: 1- Game in VGA (Dance Dance Revolution ®); 2- Walking/running reproducing the intensity obtained in the session with VGA; 3- Walking/running with intensity between 60% and 85% of MHR; 4- sedentary video game (VGS) and 5- A session control without exercise (CON), where participants remained at rest. The order of sessions was determined randomly and were carried at with a minimum of 48 hours between them. The intensity was monitored by measurements of HR and PE. BP and cardiac autonomic modulation (CAM) were assessed before and for a period of 60 minutes after exercise, at intervals of 10 minutes between each measurement.

Adaptation to the game and instructions before study Before starting the experimental protocols, the volunteers performed three sessions of adaptation with 20 minutes duration each. In these sessions, they were instructed about the proper way of handling the VGA and VGS instruments, which were passed the necessary guidance on the different directions of arrows used in the game. These three sessions proved sufficient for them to understand the dynamics of the two games and obtain enough coordination to play without interruption.

After adaptation period, a schedule was made with voluntaries to the experimental procedures and they were instructed not to drink caffeine-containing foods and drinking alcoholic beverages for at least 48 hours before of the each experimental session.

AVG and SVG procedures The VGA utilized was Dance Dance Revolution® (SSD Company Ltd., Shiga, Japan) to Playstation 2® (San Mateo, CA, USA). In this VGA the practitioner simulates a synchronized dance for footsteps ordered on a carpet (matpad) containing the areas to be trodden that replace traditional buttons of a control VGS. The style of the music used in the game is similar to those used in gyms. The game consists of passing arrows in four directions that appears on the screen at randomly and in the rhythm of different songs contained in the game. When the arrows pass on the screen, the player must step on the corresponding arrow on the carpet, in the music rhythm. At the end of each music, immediately next music was selected to minimize the time interval between them. Was connected to the video game a multimedia projector used as screen, where it was played the game image.

The VGS game was the same as VGA, with the difference only that the carpet was replaced by joystick and volunteers remained seated during the game. Both sessions VGA as VGS lasted for 60 minutes. Heart rate was measured every 10 min using um heart rate monitor (Polar ® brand, model RS800CX, Polar ElectroOy, Kempele, Finland).

Aerobic Exercise Protocol The subjects performed two aerobic exercise sessions lasting 60 minutes on a treadmill (Moviment® LX160i - Brudden LTDA, Amazon, Brazil). One session was performed in intensity similar to the intensity reached during the session VGA and the other session was performed with moderate intensity (ranged between 60% to 85% of maximum reserve heart rate).

Heart rate was monitored by heart rate monitor (Polar ® brand, model RS800CX, Polar ElectroOy, Kempele, Finland) every 10 minutes to ensure that volunteers maintain the predetermined intensity during exercise on treadmill. For the exercise protocol on the treadmill in the intensity of AVG, the lowest and highest measured heart rate found in the video game was adopted as a target zone for the heart rate on the treadmill. To the protocol on moderate intensity, the target heart rate was determined according to equation (equation 1) proposed by Karvonen, et al.20:

Equation I FCT = FCR + i%(FCM-FCR), FCT= heart rate training; FCR = heart rate at rest;; FCM = Maximum heart rate; i% = training intensity

During the rest period the Subjective Perception Scale of Borg effort 21 was presented to the subjects with indices 6-20 for the subjects become acquainted with fatigue stages that are from very mild to exhaustive. During the games or exercise on the treadmill, the PE was questioned every 10 minutes.

Blood Pressure Monitoring After the arrival of the subjects to the data collection site, they were instructed to remain seated for 10 minutes in a quiet room, illuminated with controlled temperature between 295,1ºC and 298,1ºC and then was measured the baseline BP. New BP measurements were taken immediately after the end of exercise and for 60 minutes of the post exercise or video game procedures recovery every 10 minutes. BP was measured by auscultation, following strictly the protocol proposed in the VI Brazilian Guidelines on Hypertension22. For Was used a aneroid sphygmomanometer (WelkinAlllyn®, Skaneateles Falls, New York, USA) with an accuracy of two millimeters of mercury and previously calibrated against a mercury column and a stethoscope Premiun® mark (G-Tech).

Cardiac Autonomic Modulation (CAM) CAM was determined by recording the variability RR interval of HR, using the hear rate monitor Polar ® RS800CX (Polar ElectroOy, Kempele, Finland). The CAM was recorded after 10 minutes of initial rest and recovery post treadmill or video game procedures for 60 minutes every 10 minutes. Each measure lasted five minutes. Data were transported through an infrared device to a computer provided with software of the same manufacturer. The data are analyzed in the frequency domain (sympathetic-vagal balance - LF / HF) in software Kubios (University of Eastern Finland, Kuopio, Finland).

Conditions
Hypertension
Being tested
AVideogame, SVideogame, EMIntensity, EISVideogame, Control
Medical subject headings
Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AVideogameDevice

    Participants active video game played by a period of 60 minutes, then remain at rest for the evaluation of post-exercise blood pressure for an additional period of 60 minutes.

  • SVideogameDevice

    Participants sedentary video game played by a period of 60 minutes, then remain at rest for the evaluation of post-exercise blood pressure for an additional period of 60 minutes.

  • EMIntensityDevice

    Participants performed walking on a treadmill at moderate intensity by a period of 60 minutes, then remain at rest for the evaluation of post-exercise blood pressure for an additional period of 60 minutes.

  • EISVideogameDevice

    Participants performed walking on a treadmill in intensity similar to the game by a period of 60 minutes, then remain at rest for the evaluation of post-exercise blood pressure for an additional period of 60 minutes.

  • ControlDevice

    participants remained at rest for a period of 60 minutes, then remain at rest for the evaluation of post-exercise blood pressure for an additional period of 60 minutes.

Study groups in NCT02578485
Study groupRoleWhat they receive
AVideogameExperimentalSession with active video game lasting 60 minutes performing heart rate measurements every 10 minutes and evaluating the perceived exertion.
Receives: Device: AVideogame
SVideogameActive comparatorSession with active video sedentary lasting 60 minutes performing heart rate measurements every 10 minutes and evaluating the perceived exertion.
Receives: Device: SVideogame
EMIntensityPlacebo comparatorSession with walk on a treadmill with moderate intensity lasting 60 minutes performing heart rate measurements every 10 minutes and evaluating the perceived exertion.
Receives: Device: EMIntensity
EISVideogamePlacebo comparatorSession with walk on a treadmill with intensity similar reached in session with VGA and lasting 60 minutes performing heart rate and perceived exertion measurements every 10 minutes.
Receives: Device: EISVideogame
ControlSham comparatorParticipants remained for 60 minutes at rest performing heart rate measurements every 10 minutes and evaluating the perceived exertion.
Receives: Device: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Blood pressure

    Measured: Change from baseline Bood Pressure at 60 minutes post exercise in the same experimental session

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Oct 2015 (estimated)
  2. Study startJul 2013
  3. Primary completionSep 2013
  4. Study completionDec 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02578485
Sponsor's protocol ID
FUParana
Status last verified
Oct 2015
First submitted
10 Oct 2015
Last updated
19 Oct 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing AVideogame, SVideogame and EMIntensity in people with Hypertension, run by Federal University of Paraíba.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Blood pressure (time frame: Change from baseline Bood Pressure at 60 minutes post exercise in the same experimental session). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2015.

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Clinical Trial NCT02578485 | AzTrials