- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02598882
Virtual Reality as a Tool for Rehabilitation on Elderly People
October 19, 2017 updated by: Daysi Tobelem, University of Nove de Julho
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
13
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
São Paulo, Brazil
- Dirceu Costa
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: treadmill
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
|
Patients will be an assessment of quadriceps muscle strength by surface electromyography, before and after a 30-minute activity in treadmill.
|
|
Active Comparator: videogame
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
|
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
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Assessment of quadriceps muscle fatigue
Time Frame: one year
|
one year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Evaluation of heart rate's
Time Frame: one year
|
during the activities the patients will be evaluated as the heart rate variation, by means of a frequency meter
|
one year
|
|
Evaluation of peripheral oxygen saturation
Time Frame: one year
|
During the activities the patients will be evaluated as the peripheral oxygen saturation, by means of a Pulse Oximeter.
|
one year
|
|
Assessment of energy expenditure
Time Frame: one year
|
during the implementation of the proposed activities, patients will be assessed to the energy expenditure with the use of an armband
|
one year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Dirceu Costa, Doctor, University of Nove de Julho
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2014
Primary Completion (Actual)
July 1, 2015
Study Completion (Actual)
November 1, 2016
Study Registration Dates
First Submitted
October 16, 2015
First Submitted That Met QC Criteria
November 4, 2015
First Posted (Estimate)
November 6, 2015
Study Record Updates
Last Update Posted (Actual)
October 23, 2017
Last Update Submitted That Met QC Criteria
October 19, 2017
Last Verified
October 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- ExerRehab
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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