NCT02578485

Brief 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. 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable hypertension

Timeline
Completed

Started Jul 2013

Shorter than P25 for not_applicable hypertension

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

October 10, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 19, 2015

Completed
Last Updated

October 19, 2015

Status Verified

October 1, 2015

Enrollment Period

2 months

First QC Date

October 10, 2015

Last Update Submit

October 15, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • Blood pressure

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

Study Arms (5)

AVideogame

EXPERIMENTAL

Session with active video game lasting 60 minutes performing heart rate measurements every 10 minutes and evaluating the perceived exertion.

Device: AVideogame

SVideogame

ACTIVE COMPARATOR

Session with active video sedentary lasting 60 minutes performing heart rate measurements every 10 minutes and evaluating the perceived exertion.

Device: SVideogame

EMIntensity

PLACEBO COMPARATOR

Session with walk on a treadmill with moderate intensity lasting 60 minutes performing heart rate measurements every 10 minutes and evaluating the perceived exertion.

Device: EMIntensity

EISVideogame

PLACEBO COMPARATOR

Session 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.

Device: EISVideogame

Control

SHAM COMPARATOR

Participants remained for 60 minutes at rest performing heart rate measurements every 10 minutes and evaluating the perceived exertion.

Device: Control

Interventions

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.

AVideogame

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.

SVideogame

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.

EMIntensity

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.

EISVideogame
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.

Control

Eligibility Criteria

Age45 Years - 59 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Post-graduate

Study Record Dates

First Submitted

October 10, 2015

First Posted

October 19, 2015

Study Start

July 1, 2013

Primary Completion

September 1, 2013

Study Completion

December 1, 2013

Last Updated

October 19, 2015

Record last verified: 2015-10