Benefits of Digital Dance Game Participation by Older Adults on Brain Gray Matter Volume, Physical Function, Cognitive Performance, and Quality of Life: a Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change in MRI study
研究概览
简要总结
This study aims to examine the clinical efficacy of dancing somatosensory videogames 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
This randomized controlled trial followed the CONSORT guidelines to compare the clinical efficacy of the intervention group with the control group. The intervention group and control group were randomly allocated (1:1) with no stratification. The intervention group received the dance somatosensory videogame (DSG) training program at the community health center, which consisted of two 30-minute sessions per week for 6 months. The control group were provided with health education for healthy aging and were followed by telephone survey for their daily activities every month during the study period.
The primary outcome of the trial was changes of gray matter volume of the brain done by 3T brain magnetic resonance imaging during the study period. The secondary outcomes included cognitive performance, quality of life, physical activities, resilience, and demoralization. For all outcome variables, the measurements at the baseline and 6-month follow-up were examined by a random intercept and a fixed slope, and the effect of the intervention was estimated by using the Generalized Estimating Equation.
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
- None
入排标准
- 年龄范围
- 55 Years 至 76 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 video dancing games in the past three months.
- •Engaged in video dancing games more than three times per year in the past three years.
结局指标
主要结局
Change in MRI study
时间窗: from baseline to 6 months
Change in MRI study from baseline to 6 months in the intervention group.
次要结局
- EuroQol instrument (EQ-5D)(from baseline to 6 months)
- Montreal Cognitive Assessment (MoCA)(from baseline to 6 months)
- International Physical Activity Questionnaire (IPAQ)(from baseline to 6 months)
- Brief Resilience Scale (BRS)(from baseline to 6 months)
- Demoralization Scale-Mandarin Version (DS-MV)(from baseline to 6 months)