Evaluation of the Effects of the New Program for Cognitive Enhancement and Improvement in the Elderly

January 9, 2018 updated by: Samsung Medical Center
The purpose of this study is to investigate the effect of cognitive rehabilitation program on the improvement of cognitive functions in normal elderly subjects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The cognitive rehabilitation program was developed to improve cognitive functions of the elderly or patients with cognitive impairments. The study will enroll 40 healthy subjects with a normal cognitive function between 55 and 85 years of age. Forty subjects will be randomly assigned into two groups. Subjects in the intervention group will receive four weeks of cognitive rehabilitation training, three times per week and 30 minutes per day. The control group will not receive any intervention. The investigator will measure their cognitive and brain functions three times at pre-intervention, post-intervention and four weeks after intervention to assess the effectiveness of the cognitive training program.

Study Type

Interventional

Enrollment (Actual)

40

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

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

55 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Normal Healthy individuals
  • No cognitive impairments
  • No history of neurologic diseases

Exclusion Criteria:

  • Severe cognitive problems
  • Other problems disturbing cognitive tests

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group1
Cognitive rehabilitation program will be administered for 4 weeks, three times a week, 30 minutes a day
Other: Cognitive rehabilitation program
Cognitive rehabilitation programs have been developed to improve the cognitive functions of the elderly or patients with cognitive impairments. The program includes sub-categories such as attention, working memory, memory and executive functions with various levels of difficulty.
Other Names:
  • Computer-aided Cognitive Rehabilitation Training System
No Intervention: Group2
No intervention will be administered

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline performance on Digit Span Test (Neuropsychological test) at 4 weeks and 8 weeks
Time Frame: baseline, 4 weeks and 8 weeks
It measures auditory attention span and includes forward and backward trials. The participant listens to a series of numbers and calls the sequence correctly. The sequence increases in each trial. The final score is the longest number of sequential digits that the participant can remember correctly. The scores range from 3 to 8. The higher the score, the better the performance.
baseline, 4 weeks and 8 weeks
Change from baseline performance on Visual Span Test (Neuropsychological test) at 4 weeks and 8 weeks
Time Frame: baseline, 4 weeks and 8 weeks
It measures spatial attention span and includes forward and backward trials. The participant will see sequence of blocks "lit up" on a computer screen, and then repeat the sequence in order or back in order. The sequence increases in each trial. The final score is the longest number of sequential blocks that the participant can remember correctly. The scores range from 3 to 8. The higher the score, the better the performance.
baseline, 4 weeks and 8 weeks
Change from baseline performance on Visual Continuous Performance Test (Neuropsychological test) at 4 weeks and 8 weeks
Time Frame: baseline, 4 weeks and 8 weeks
It measures a participant's visual sustained and selective attention. The participant will see numbers from "0" to "9" presented on a computer screen and they must click the mouse when "3" appeared. The test will run for 9 minutes. The main scores produced in this test are omission errors, commission errors and reaction times. Higher score means worse performance.
baseline, 4 weeks and 8 weeks
Change from baseline performance on Auditory Continuous Performance Test (Neuropsychological test) at 4 weeks and 8 weeks
Time Frame: baseline, 4 weeks and 8 weeks
It measures a participant's auditory sustained and selective attention. The participant will hear numbers from "0" to "9", and when they hear "3" they must click the mouse. The test will run for 9 minutes. The main scores produced in this test are omission errors, commission errors and reaction times. Higher score means worse performance.
baseline, 4 weeks and 8 weeks
Change from baseline performance on Stroop test (Neuropsychological test) at 4 weeks and 8 weeks
Time Frame: baseline, 4 weeks and 8 weeks
It measures a participant's processing speed, selective attention and inhibitory control. The participant will be asked to read 'word' of the colored words or 'name of the color' of the colored words in separate trials. The main scores produced in this test are completion time and errors. The contrast score of the two trial's completion time means interference.
baseline, 4 weeks and 8 weeks
Change from baseline performance on Auditory Verbal Learning test (Neuropsychological test) at 4 weeks and 8 weeks
Time Frame: baseline, 4 weeks and 8 weeks
It measures participant's verbal memory. The participant will hear 15 words and recall them immediately and after 20 minutes again. The main scores produced in this test are the numbers of recalled words of the immediate and delayed trials. Immediate memory score is the sum of 5 trial's correct response and score ranges between 0 and 60. Delayed memory score is the correct response of the delayed trial and the score range is 0 to 15. Higher score means better performance.
baseline, 4 weeks and 8 weeks
Change from baseline performance on Trail Making Test (Neuropsychological test) at 4 weeks and 8 weeks
Time Frame: baseline, 4 weeks and 8 weeks
It consists of type A and type B trials. The participant should connect the numbers (1~25) as quickly as possible in Type A trial, and connect the numbers (1~13) and alphabets (A~L) alternatively as quickly as possible in type B trial. The main scores produced in this test are completion time and errors. Higher score means worse performance.
baseline, 4 weeks and 8 weeks
Change from baseline performance on Visual Recognition test (Neuropsychological test) at 4 weeks and 8weeks
Time Frame: baseline, 4 weeks and 8 weeks
It measures participant's visual memory. The participant will see 15 visual patterns presented on a computer screen and recognize them immediately. The participant will be asked to recognize the 15 patterns after 20 minutes again. The main scores produced in this test are the numbers of recognized patterns in immediate and delayed trials. Immediate memory score is the sum of 5 trial's correct response and score ranges between 0 and 60. Delayed memory score is the correct response of the delayed trial and the score range is 0 to 15. Higher score means better performance.
baseline, 4 weeks and 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline score on Korean Version of Geriatric Depression Test Short Form (Depression scale) at 4 weeks and 8 weeks
Time Frame: baseline, 4 weeks and 8 weeks
It measures depressive symptoms of the participants. The score ranges between 0 and 15. Higher score means severe depression.
baseline, 4 weeks and 8 weeks
Change from baseline activity on functional Near-Infrared Spectroscopy (fNIRS) at 4 weeks and 8 weeks
Time Frame: baseline, 4 weeks and 8 weeks
It measures brain activity during cognitive tasks to see if cognitive training affects brain function.
baseline, 4 weeks and 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Investigators

  • Principal Investigator: Yun-Hee Kim, PhD, Samsung Medical Center

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)

December 23, 2015

Primary Completion (Actual)

December 15, 2016

Study Completion (Actual)

December 15, 2016

Study Registration Dates

First Submitted

December 28, 2017

First Submitted That Met QC Criteria

January 9, 2018

First Posted (Actual)

January 17, 2018

Study Record Updates

Last Update Posted (Actual)

January 17, 2018

Last Update Submitted That Met QC Criteria

January 9, 2018

Last Verified

December 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2015-10-080-005

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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