AgingNCT04615897
Efficiency of New Technologies in the Aging Process
A study testing new tecnology intervention in people with Aging, run by University of Seville.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- new tecnology intervention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- No sites listed yet
- Study dates
- Mar 2013to Jan 2014
- 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
- Be 60 years old or older.
- Have compensated the auditory or visual deficits that could suffer
- Absence of musculoskeletal problems that hinder functionality
Who cannot join
- 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
About this study
Official title: 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.
Read the 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).
- Conditions
- Aging
- Being tested
- new tecnology intervention
- Keywords
- gait, attention, memory
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
new tecnology interventionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental aging | Experimental | The subjects received 16 sessions (Two per week) of exercise with new tecnology between two measurements of the variable. Receives: Procedure: new tecnology intervention |
| Control Aging | No intervention | The subjects doesn´t received 16 sessions (Two per week) of exercise with new tecnology between two measurements of the variable. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attention
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.
Measured: At the start and the end of the study (65 days)
Memory
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.
Measured: At the start and the end of the study (65 days)
Balance
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
Measured: At the start and the end of the study (65 days)
Gait
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
Measured: At the start and the end of the study (65 days)
Global autonomy and risk of falls
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.
Measured: At the start and the end of the study (65 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2020
- Study startMar 2013
- Primary completionJun 2013
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Seville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria LuIsa Benitez Lugo, University of Seville
- Investigators
- Benitez Lugo, PhD, Principal investigator, University of Seville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04615897
- Sponsor's protocol ID
- MLugo - USeville
- Status last verified
- Nov 2020
- First submitted
- 6 Mar 2018
- Last updated
- 4 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of New Technologies in the Balance, Gait and Cognitive Function in Healthy Elderly
- ClinicalTrials.gov ID
- NCT04615897
- Acronym / sponsor ID
- MLugo - USeville
- Conditions
- Aging
- Keywords
- gait, attention, memory
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University of SevilleUniversity, hospital or other
- Study start
- Mar 2013 (actual)
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 4 Nov 2020 (actual)
- 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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental aging | Experimental | Procedure: new tecnology interventionThe subjects received 16 sessions (Two per week) of exercise with new tecnology between two measurements of the variable. |
| Control Aging | No intervention | –The subjects doesn´t received 16 sessions (Two per week) of exercise with new tecnology between two measurements of the variable. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Be 60 years old or older.
- Have compensated the auditory or visual deficits that could suffer
- Absence of musculoskeletal problems that hinder functionality
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| new tecnology interventionThe 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. | Procedure or surgery | Experimental aging |
Primary outcome
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.
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.
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
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
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.
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 4 Nov 2020.
- Individual participant dataSharing planned: No
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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.
Benitez Lugo, PhD principal investigator
University of Seville
Questions about this trial
What is this clinical trial studying?
A study testing new tecnology intervention in people with Aging, run by University of Seville.
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 3 inclusion and 4 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 4 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Attention (time frame: At the start and the end of the study (65 days)). The study lists 5 primary outcomes in all. 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 4 Nov 2020.