- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04615897
Efficiency of New Technologies in the Aging Process
November 3, 2020 updated by: Maria LuIsa Benitez Lugo, University of Seville
Effectiveness of New Technologies in the Balance, Gait and Cognitive Function in Healthy Elderly
This study tries to analyze the effectiveness of the application of the new technology in the maintenance of an active time.
To do this, the investigators performed a laboratory test where they evaluated the physical and cognitive variables before and after the intervention and analyzed the improvement in the psychocognitive abilities in the experimental group and the use of physical and cognitive functions in the control group.
Study Overview
Detailed Description
The main objective of this study is the demonstration of the effectiveness of a motor task, making use of the Nintendo Wii video game console, in healthy elderly people, as well as demonstrating the interaction between the physical and cognitive aspects and the decline that in these functions causes the aging process.
Methodology: A double blind, controlled and randomized clinical trial was developed on a total sample of 46 subjects, with a mean age of 72.59 years.
For the collection of data, the following evaluation scales and computerized tests were passed (Cognitive Miniexamen, Depression Scale, Berg Scale, Tinetti Scale, Timed Up and Go test, Oddball Test and the Attention Network Test).
Study Type
Interventional
Enrollment (Actual)
46
Phase
- Not Applicable
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
Yes
Genders Eligible for Study
All
Description
Inclusion criteria:
- Be 60 years old or older.
- Have compensated the auditory or visual deficits that could suffer
- Absence of musculoskeletal problems that hinder functionality
Exclusion criteria:
- Presents cognitive impairment
- Obtain values in the Geriatric Depression Scale> 9.
- Presenten pathologies where the development of a motor task is counterproductive
- Sleep less than 6 hours a day
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: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental aging
The subjects received 16 sessions (Two per week) of exercise with new tecnology between two measurements of the variable.
|
The intervention consists of 16 sessions, performed with a frequency of twice a week, the final evaluation was made within three days after the end of the last treatment session.
It is used for the motor task, the "Fishing Under Zero" exercise, included within the "balance" modality and the so-called "Step Plus" located in the aerobic exercise folder.
Each subject carried out the training taking into account the following methodology: 3 cycles of the "Fishing under zero" exercise, one cycle of the "Step Plus" exercise and 3 cycles of the "Fishing under zero" exercise, the approximate duration of the task being about 30 minutes.
|
|
No Intervention: Control Aging
The subjects doesn´t received 16 sessions (Two per week) of exercise with new tecnology between two measurements of the variable.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Attention
Time Frame: At the start and the end of the study (65 days)
|
This variable is obtained by performing two tests designed to quantify this cognitive function, using the E-prime computer program.
Both tests are developed in the psychophysiology laboratory of the University of Seville.
The first is to complete the "Test Oddball" and the second the "Attention Network Test-ELDERLY".
Both tests measure the reaction times, in seconds and, the precision, in percentages.
It involves two continuous quantitative measurements.
|
At the start and the end of the study (65 days)
|
|
Memory
Time Frame: At the start and the end of the study (65 days)
|
This variable is obtained from the score obtained in the scale called Miniexamen Cognitive (MEC), in which the subject must: respond to a series of questions that we perform related to the orientation, try to set a series of three words that the evaluator says to remember them later, develop a series of calculations, and work on a series of aspects related to language and its construction.
At the end of the test, the subject obtains a score that determines the presence or absence of a cognitive problem.
We consider it as a discrete quantitative variable.
|
At the start and the end of the study (65 days)
|
|
Balance
Time Frame: At the start and the end of the study (65 days)
|
This variable is studied using the Berg scale, which allows to quantify the balance of the subject in different positions, obtaining a global score that guides us on the general state of the balance function and guides us on a wheelchair dependence, the use of some technical help or total independence for the development of the march.
We consider it as a discrete quantitative variable
|
At the start and the end of the study (65 days)
|
|
Gait
Time Frame: At the start and the end of the study (65 days)
|
This variable is configured by the application of the "Timed up and Go test" scale, which quantifies the time the subject takes to get up from a chair, walk 3 meters and return back to the starting position.
We consider this variable as continuous quantitative
|
At the start and the end of the study (65 days)
|
|
Global autonomy and risk of falls
Time Frame: At the start and the end of the study (65 days)
|
This variable is analyzed through the application of the Tinetti Scale, which evaluates in a single instrument the function of balance and gait, as well as the risk of falls that elderly people present.
In this sense, we can consider that it evaluates global autonomy.
We consider this variable as discrete quantitative.
|
At the start and the end of the study (65 days)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Benitez Lugo, PhD, University of Seville
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 (Actual)
March 1, 2013
Primary Completion (Actual)
June 1, 2013
Study Completion (Actual)
January 1, 2014
Study Registration Dates
First Submitted
March 6, 2018
First Submitted That Met QC Criteria
November 3, 2020
First Posted (Actual)
November 4, 2020
Study Record Updates
Last Update Posted (Actual)
November 4, 2020
Last Update Submitted That Met QC Criteria
November 3, 2020
Last Verified
November 1, 2020
More Information
Terms related to this study
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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