NCT04615897

Brief 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 psychocognitive abilities in the experimental group and the use of physical and cognitive functions in the control group.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2013

Shorter than P25 for not_applicable

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

March 6, 2018

Completed
2.7 years until next milestone

First Posted

Study publicly available on registry

November 4, 2020

Completed
Last Updated

November 4, 2020

Status Verified

November 1, 2020

Enrollment Period

3 months

First QC Date

March 6, 2018

Last Update Submit

November 3, 2020

Conditions

Keywords

gaitattentionmemory

Outcome Measures

Primary Outcomes (5)

  • 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.

    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.

    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

    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

    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.

    At the start and the end of the study (65 days)

Study Arms (2)

Experimental aging

EXPERIMENTAL

The subjects received 16 sessions (Two per week) of exercise with new tecnology between two measurements of the variable.

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.

Interventions

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.

Experimental aging

Eligibility Criteria

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

You may qualify if:

  • Be 60 years old or older.
  • Have compensated the auditory or visual deficits that could suffer
  • Absence of musculoskeletal problems that hinder functionality

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Benitez Lugo, PhD

    University of Seville

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

March 6, 2018

First Posted

November 4, 2020

Study Start

March 1, 2013

Primary Completion

June 1, 2013

Study Completion

January 1, 2014

Last Updated

November 4, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share