NCT02598882

Brief Summary

Assessment of energy expenditure and the quadriceps muscle fatigue of healthy seniors, after two physical activities, being one of an activity guided by interactive video game (Xbox) and another on the treadmill. The participants will perform the activities in two different days, the order will be obtained by randomization.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 16, 2015

Completed
21 days until next milestone

First Posted

Study publicly available on registry

November 6, 2015

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

October 23, 2017

Status Verified

October 1, 2017

Enrollment Period

10 months

First QC Date

October 16, 2015

Last Update Submit

October 19, 2017

Conditions

Keywords

ElderlyVideogameenergy expenditureelectromyographyrehabilitation

Outcome Measures

Primary Outcomes (1)

  • Assessment of quadriceps muscle fatigue

    one year

Secondary Outcomes (3)

  • Evaluation of heart rate's

    one year

  • Evaluation of peripheral oxygen saturation

    one year

  • Assessment of energy expenditure

    one year

Study Arms (2)

treadmill

ACTIVE COMPARATOR

patients will be 30 minutes of activity on treadmill, before and after exercise the same shall be assessed as fatigue of quadriceps by surface electromyography

Device: treadmill

videogame

ACTIVE COMPARATOR

patients will be 30 minutes of activity with video games, before and after exercise the same shall be assessed as fatigue of quadriceps by surface electromyography

Device: videogame

Interventions

videogameDEVICE

Patients will be an assessment of quadriceps muscle strength by surface electromyography, before and after a 30-minute guided activity through an active video game

Also known as: exergame, virtual reality
videogame
treadmillDEVICE

Patients will be an assessment of quadriceps muscle strength by surface electromyography, before and after a 30-minute activity in treadmill.

treadmill

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participate in this study elderly
  • Of both sexes,
  • Over 60 years,
  • without cardiac and respiratory diseases
  • Who accept to participate in the research, giving your consent by signing the informed consent

You may not qualify if:

  • Those who oppose the signing of the informed consent
  • Submit proposals and activities intolerance who can't understand or accomplish correctly the procedures due to physical and or mental limitations.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dirceu Costa

São Paulo, Brazil

Location

MeSH Terms

Interventions

Exercise Test

Intervention Hierarchy (Ancestors)

Heart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisRespiratory Function TestsDiagnostic Techniques, Respiratory SystemErgometryInvestigative Techniques

Study Officials

  • Dirceu Costa, Doctor

    University of Nove de Julho

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

October 16, 2015

First Posted

November 6, 2015

Study Start

September 1, 2014

Primary Completion

July 1, 2015

Study Completion

November 1, 2016

Last Updated

October 23, 2017

Record last verified: 2017-10

Locations