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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05808426
Other study ID # YM108123F_M
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 28, 2020
Est. completion date March 20, 2022

Study information

Verified date June 2020
Source National Yang Ming University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study aims to examine the clinical efficacy of online Mahjong in improving physical health, cognitive performance, happiness, laboratory biomarkers, and structural brain imaging (magnetic resonance imaging, MRI) by a randomized controlled trial design, and hopefully to expand the scope of healthy aging intervention activities with strong scientific evidence.


Description:

Psychomotor function among older adult's decline was associated with reducing people interaction during pandemic has been reported. The research focused on examining the benefit and efficacy of digital based Mahjong games with 6-month intervention is very limited or none. A random control design was conducted with comparing intervention group and with control group, followed the CONSORT guidelines. Six months program was intervened to ensure the impact of the intervention. Primary outcome is brain imagery changes between groups, which showed changes in temporal fusiform cortex but not in resting-state fMRI. The total score of MoCA, delayed recall was increase from baseline to after intervention in experimental group. Overall cognitive function and visuospatial/executive, in experimental group improved more than control group. Improving self-rating daily health status as associated with achievement rate of Mahjong game. Increasing level of resilience was associated with demoralization level, subtraction of cognitive function, and 5th month walking steps. In addition, affecting incased self -rate overall heath was related to demoralization. In short, online mahjong intervention has positive impact on older adults in cognitive function , resilience, demoralization and overall quality of life.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date March 20, 2022
Est. primary completion date November 1, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 55 Years to 74 Years
Eligibility Inclusion Criteria: 1. Age = 55 years old. 2. More than 6 years of formal education. 3. Can communicate in Mandarin and Taiwanese. 4. Can accept MRI examination without claustrophobia. 5. Can understand the research process, meet the requirements of the research, and can sign the consent form and participate in the subject. Exclusion Criteria: 1. Have engaged in any Mahjong games in the past three months. 2. Engaged in Mahjong games more than three times per year in the past three years.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Bonus Winner Mahjong
Bonus Winner Mahjong developed by Bonus Winner Online Entertainment Co., Ltd. The participants in experimental group played three times a week, each time requiring at least lasting 30 minutes, for half of a year.

Locations

Country Name City State
Taiwan Center for Geriatrics and Gerontology, Taipei Veterans General Hospital Taipei

Sponsors (1)

Lead Sponsor Collaborator
National Yang Ming University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in MRI study from baseline to 6 months in the intervention group. Change in MRI study from baseline to 6 months in the intervention group. baseline and 6 months
Secondary Montreal Cognitive Assessment (MoCA) Cognitive function measure by MoCA , which comprise a 30-question test.Score range: 0-30, and a score of 26 and higher is considered normal. baseline and 6 months
Secondary EuroQol instrument (EQ-5D) Quality of life measure by EQ-5D, which include five questions on mobility, self care, pain, usual activities, and psychological status. Score range: There are three level of the answers for each question, the maximum score of 1 refers to the best condition without problem, and higher scores refers more severe of the issue. Moreover, the visual analogue scale (VAS) which from 0-100, higher score indicating better health status. baseline and 6 months
Secondary International Physical Activity Questionnaire (IPAQ) Physical activity measured by IPAQ, indicates that spent being physically active within the prior 7 days. Score range: There are no established thresholds for presenting MET-minutes, the IPAQ Research Committee proposes that reported as comparisons of median values and interquartile ranges for different populations. baseline and 6 months
Secondary Brief Resilience Scale (BRS) Resilience measured by BRS to assess ability to bounce back or recover from stress and adversity. Score range: 6-30, and higher scores refers to higher level of resilience. baseline and 6 months
Secondary Demoralization Scale-Mandarin Version (DS-MV) Demoralization measure by DS-MV, comprised 24 items and each rated on a five-point Likert scale.Score range: 0-96, and cut-off point score =30 was considered to identified demoralization. baseline and 6 months
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