跳至主要内容
临床试验/NCT05808426
NCT05808426已完成不适用

Randomized Trial of Online Mahjong Intervention to Promote Cognitive Function and Health Status in Community-dwelling Middle Aged and Older Adults.

National Yang Ming Chiao Tung University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年7月28日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Change in MRI study from baseline to 6 months in the intervention group.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Investigator)

盲法说明

Participants were not explicitly informed about their group assignment and there was no contact between study investigators and participants during the study period. The intervention allocation was masked from investigators by anonymized coding, and the individuals who were assigned interventions were not involved in assessing outcomes and analyzing data. The investigators also avoided any potential interactions between participants in either intervention group.

入排标准

年龄范围
55 Years 至 74 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Age ≥ 55 years old.
  • •More than 6 years of formal education.
  • •Can communicate in Mandarin and Taiwanese.
  • •Can accept MRI examination without claustrophobia.
  • •Can understand the research process, meet the requirements of the research, and can sign the consent form and participate in the subject.

排除标准

  • •Have engaged in any Mahjong games in the past three months.
  • •Engaged in Mahjong games more than three times per year in the past three years.

研究组 & 干预措施

observation with no intervention group

No Intervention

The control group only performed routine data collection; the research assistant asked the subjects about their usual activities by telephone every month to understand their physical activity in this half of the year.

Mahjong group

Experimental

The experimental group intervened a 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.

干预措施: Bonus Winner Mahjong (Device)

结局指标

主要结局

Change in MRI study from baseline to 6 months in the intervention group.

时间窗: baseline and 6 months

Change in MRI study from baseline to 6 months in the intervention group.

次要结局

  • EuroQol instrument (EQ-5D)(baseline and 6 months)
  • Demoralization Scale-Mandarin Version (DS-MV)(baseline and 6 months)
  • Brief Resilience Scale (BRS)(baseline and 6 months)
  • International Physical Activity Questionnaire (IPAQ)(baseline and 6 months)
  • Montreal Cognitive Assessment (MoCA)(baseline and 6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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