AgedNCT02598882
Virtual Reality as a Tool for Rehabilitation on Elderly People
A study testing videogame and treadmill in people with Aged, run by University of Nove de Julho at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aged
- What is being tested?
- videogame and treadmill
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteBrazil
- Study dates
- Sep 2014to Nov 2016
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Physical Activity With an Active Video Game Provides Bigger Energy Expenditure and Less Muscle Fatigue
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.
- Conditions
- Aged
- Being tested
- videogame, treadmill
- Keywords
- Elderly, Videogame, energy expenditure, electromyography, rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
videogameDevice
Also called exergame, virtual reality
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
treadmillDevice
Patients will be an assessment of quadriceps muscle strength by surface electromyography, before and after a 30-minute activity in treadmill.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Device: videogame |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of quadriceps muscle fatigue
Measured: one year
Secondary outcomes (3)
Evaluation of heart rate's
during the activities the patients will be evaluated as the heart rate variation, by means of a frequency meter
Measured: one year
Evaluation of peripheral oxygen saturation
During the activities the patients will be evaluated as the peripheral oxygen saturation, by means of a Pulse Oximeter.
Measured: one year
Assessment of energy expenditure
during the implementation of the proposed activities, patients will be assessed to the energy expenditure with the use of an armband
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2015 (estimated)
- Study startSep 2014
- Primary completionJul 2015
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daysi Tobelem, University of Nove de Julho
- Investigators
- Dirceu Costa, Doctor, Study director, University of Nove de Julho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02598882
- Sponsor's protocol ID
- ExerRehab
- Status last verified
- Oct 2017
- First submitted
- 16 Oct 2015
- Last updated
- 23 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity With an Active Video Game Provides Bigger Energy Expenditure and Less Muscle Fatigue
- ClinicalTrials.gov ID
- NCT02598882
- Acronym / sponsor ID
- ExerRehab
- Conditions
- Aged
- Keywords
- Elderly, Videogame, energy expenditure, electromyography, rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 6 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| treadmill | Active comparator | Device: treadmillpatients will be 30 minutes of activity on treadmill, before and after exercise the same shall be assessed as fatigue of quadriceps by surface electromyography |
| videogame | Active comparator | Device: videogamepatients 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 |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| videogameAlso: exergame, virtual realityPatients will be an assessment of quadriceps muscle strength by surface electromyography, before and after a 30-minute guided activity through an active video game | Device | videogame |
| treadmillPatients will be an assessment of quadriceps muscle strength by surface electromyography, before and after a 30-minute activity in treadmill. | Device | treadmill |
Primary outcome
Assessment of quadriceps muscle fatigue
Time frame: one year
3 secondary outcomes
Evaluation of heart rate's
Time frame: one year
Evaluation of peripheral oxygen saturation
Time frame: one year
Assessment of energy expenditure
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dirceu Costa, Doctor study director
University of Nove de Julho
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing videogame and treadmill in people with Aged, run by University of Nove de Julho at 1 site in Brazil.
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 5 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 23 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Assessment of quadriceps muscle fatigue (time frame: one year). 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 23 Oct 2017.