Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04873843
Other study ID # 2021-03-011
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 16, 2021
Est. completion date August 4, 2022

Study information

Verified date April 2021
Source Samsung Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This single-blinded, randomized, controlled trial includes 32 elderly. The participants were randomized to intervention(Happy Table) and control(cognitive stimulation activity) groups. Each group is divided in 16 participants. In one session, participants in the Happy Table group completed 40 minutes of intervention using Happy Table serious game, whereas those in the Control group completed 40 minutes of cognitive stimulation game.


Description:

At the first visit, the subjects are fully informed of the study if appropriate after determining whether they meet the selection criteria. This single-blinded, randomized, controlled trial includes 32 elderly. The participants were randomized to intervention(Happy Table) and control(cognitive stimulation activity) groups. Each group is divided in 16 participants. In one session, participants in the Happy Table group completed 40 minutes of intervention using Happy Table serious game, whereas those in the Control group completed 40 minutes of cognitive stimulation game.


Recruitment information / eligibility

Status Completed
Enrollment 32
Est. completion date August 4, 2022
Est. primary completion date February 21, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years to 84 Years
Eligibility Inclusion Criteria: - community-dwelling senior citizens aged 65 to 84 - Those without a history of central nervous system(CNS) disease Exclusion Criteria: - When it is difficult to understand the task performance due to severe cognitive decline(Korean Simple Mental State Test, K-MMSE 10 points or less). - When it is difficult to use this game device due to problems such as decreased vision or fracture of the upper limb - In case of accompanying serious mental illness

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Functional digital game training group
Functional digital game training group is divided in 16 participants. In one session, participants in the functional digital game training group completed 40 minutes of intervention using various functional digital game such as working memory, memory, and attention. (Total 10 session)
Individual cognitive training
Functional digital game training group is divided in 16 participants. In one session, participants in the individual cognitive training group completed 40 minutes of intervention using various cognitive training such as working memory, memory, and attention. (Total 10 session)

Locations

Country Name City State
Korea, Republic of Samsung Medical Center Seoul

Sponsors (1)

Lead Sponsor Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from baseline performance on Stroop test (Neuropsychological test) after the intervention (Day 13). 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, After the intervention (Day 13)
Secondary Change from baseline performance on Fluency Test (Neuropsychological test) after the intervention (Day 13). This is a generative naming test. That measure how many words you can spontaneously speak within a limited time of words that fall into a specific category (e.g. animals, store goods, vegetables) or words starting with a letter (e.g. F • A • S or C·F·L). Baseline, After the intervention (Day 13)
Secondary Change from baseline performance on Trail Making Test (Neuropsychological test) after the intervention (Day 13). 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, After the intervention (Day 13)
Secondary Change from baseline performance on Digit Span Test (Neuropsychological test) after the intervention (Day 13). 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, After the intervention (Day 13)
Secondary Change from baseline performance on Auditory Verbal Learning test (Neuropsychological test) after the intervention (Day 13). 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, After the intervention (Day 13)
Secondary Change from baseline activity on functional Near-Infrared Spectroscopy (fNIRS) during the intervention(Day 1 and 12)and after intervention completion(Day 12) It measures brain activity during cognitive tasks to see if cognitive training affects brain function. Baseline, during the intervention(Day 1 and 12), Through intervention completion(Day 12)
Secondary Change from baseline activity on Contrasting Program/Go-No-Go test after the intervention (Day 13). The Contrasting Program and go-no go test requires a subject to emit a simple motor response to one cue while inhibiting the response in the presence of another cue. This test has been effective in demonstrating impulsivity (elevated commission error rate) in elderly with attention deficit. Baseline, Day 13(After the intervention)
Secondary Change from baseline activity on Geriatric Depression Scale (GDS) after the intervention (Day 13). GDS is a 15-item self-report assessment used to identify depression in the elderly. A score of 0 to 5 is normal. A score greater than 5 suggests depression Baseline, After the intervention (Day 13)
Secondary Change from baseline activity on health-related quality of life instrument with 20 items (HINT-20) after the intervention (Day 13). The total score of the HINT-20 is converted to a 0-100 scale, with higher scores indicating better health-related quality of life. Baseline, After the intervention (Day 13)
Secondary Change from baseline activity on General Self-Efficacy Scale (GSE) after the intervention (Day 13). General self-efficacy (GSE), individuals'belief in their ability to perform well in a variety of situations. General self-efficacy (GSE) is the belief in one's competence to attempt difficult or novel tasks, and to cope with adversity arising from specific demanding situations. Baseline, After the intervention (Day 13)
Secondary Change from baseline activity on International Physical Activity Questionnaire after the intervention (Day 13). Physical Activity Questionnaire collects information on physical activity participation in three settings (or domains) as well as sedentary behaviour, comprising 16 questions. Baseline, After the intervention (Day 13)
Secondary User Satisfaction Questionnaire after intervention. We evaluate the satisfaction questionnaire for each training. After the intervention (Day 13)
Secondary Change from baseline activity on smart band activity through intervention completion(Day 12). Each participant was given an smart band(number of steps count) and instructed to wear it on the wrist during waking hours until completion of the training program. This included both intervening training days (totaling 10). Baseline, through intervention completion(Day 12)
See also
  Status Clinical Trial Phase
Completed NCT05433233 - Effects of Lifestyle Walking on Blood Pressure in Older Adults With Hypertension N/A
Recruiting NCT06032065 - Sequential Multiple Assessment Randomized Trial of Exercise for PAD: SMART Exercise for PAD (SMART PAD) Phase 3
Completed NCT05293730 - Trial of the Impact of the Electronic Frailty Integrated With Social Needs N/A
Recruiting NCT03932162 - Gene Expression Changes In Young and Geriatric Skin Early Phase 1
Completed NCT04064528 - Effects of Age on Amino Acid Delivery to Tendon N/A
Completed NCT03366129 - Blood-Brain Barrier Disruption in People With White Matter Hyperintensities Who Have Had a Stroke
Completed NCT06029920 - Influence of Overground Walking on Biomarkers, Cognitive Function, and Quality of Life in Elderly With Mild Cognitive Impairment N/A
Recruiting NCT05566938 - Study to Design a Precision Nutrition Strategy at a Group Level in the Elderly N/A
Recruiting NCT05543980 - Leg Heat Therapy in Elderly Individuals Phase 2
Completed NCT04894929 - Comprehensive Geriatric Assessment in the Monitoring of Functional Improvement N/A
Not yet recruiting NCT06071130 - Emotion, Aging, and Decision Making N/A
Enrolling by invitation NCT04641663 - Multi-target Dietary Supplement Tolerability in an Aging Population (MTDSST) N/A
Completed NCT04088006 - The Evaluation of Efficacy and Safety of Hyaluronic Acid Injection on Skin Moisturization and Elasticity N/A
Completed NCT03695081 - Patient Pathway Pharmacist - Optimal Drug-related Care N/A
Recruiting NCT05424263 - Acetate and Age-associated Arterial Dysfunction Phase 2
Completed NCT05601713 - Mitigating Heat-induced Physiological Strain and Discomfort in Older Adults Via Lower Limb Immersion and Neck Cooling N/A
Completed NCT04551339 - Zinc Versus Multivitamin Micronutrient Supplementation in the Setting of COVID-19 N/A
Recruiting NCT04997577 - Speech Perception and High Cognitive Demand N/A
Completed NCT05922475 - Efficacy of Pre-sleep or Post-exercise Protein During 12 Weeks of Resistance Exercise Training N/A
Completed NCT04015479 - Peanut Protein Supplementation to Augment Muscle Growth and Improve Markers of Muscle Quality and Health in Older Adults N/A