Smart Taiko-Drum Playing for Older Adults With Cognitive Frailty for Improving Cognitive and Physical Functions: A Randomized Controlled Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Recruitment rate
研究概览
简要总结
The objective of this randomised controlled feasibility trial is to evaluate the feasibility of the Smart Taiko Drum-playing intervention embedding the cognitive-motor dual-task training concept for older adults with cognitive frailty, and identify the preliminary efficacy of the intervention on cognitive and physical functions and frailty status.
详细描述
- Study design:
- Randomized Control Trial
- Participants:
- Community-dwelling older adults with cognitive frailty
- Setting:
- Community centres for seniors
- Intervention
- Playing Smart Taiko three times/weeks x 16 weeks for 30 - 45 minutes each session
- A Smart Taiko Drumming system has been developed for older adults to play the drumming game with their preferred music genres.
- Waitlist-control group
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 (Outcomes Assessor)
盲法说明
Trained research assistants will collect the data blinded to group assignment.
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •with cognitive frailty
- •without a diagnosis of a neurological or psychiatric condition that could affect cognitive function
- •live independently or with partial assistance
- •with pre-frailty
排除标准
- •with a significant sensory or motor impairment that would preclude participation in the intervention
- •are unable to understand or follow instructions due to language or hearing impairment
- •have already been in another cognitive or physical intervention programme within the past three months
- •are taking medications that could significantly affect cognitive or physical functions
- •with any medical condition or treatment that would contraindicate participation in the study.
研究组 & 干预措施
Smart Taiko Drumming Group
Smart Taiko Drumming
干预措施: Smart Taiko Drumming (Behavioral)
Usual Care Waitlist Control Group
Usual care
结局指标
主要结局
Recruitment rate
时间窗: Through study completion, an average of 2 years
The Proportion of eligible people recruited (= proportion of people randomised/proportion of people eligible).
Satisfaction to the intervention
时间窗: Through study completion, an average of 2 years
Satisfaction questionnaire, including questions of "Does the game provide an engaging environment for training?", "Do you think the exercise intensity suits you?"
Intervention Completion Rate
时间窗: Through study completion, an average of 2 years.
Overall intervention completion rate -defined as the proportion of participants who completed the allocated intervention with a minimum of 80% attendance. Calculated as number of participants allocated to the intervention that completed the minimum attendance (numerator)/number of participants allocated to treatment (denominator).
Attrition rate
时间窗: Through study completion, an average of 2 years
Overall attrition rate-defined as the proportion of participants at defined study points who discontinued the intervention or were lost to follow-up (calculated as number of participants that withdraw (numerator)/number of participants randomised (denominator)).
次要结局
- Memory(6 months)
- Overall cognitive function(6 months)
- Mobility and Balance(6 months)
- Body composition - Body weight(6 months)
- Body composition - body mass index(6 months)
- Body composition - percent body fat.(6 months)
- Handgrip strength(6 months)
- Verbal fluency(6 months)
- Functional capacity and endurance(6 months)
- Safety concerns of the intervention(Through study completion, an average of 2 years.)
- Executive function(6 months)
- Loneliness(6 months)
- Frailty status(6 months)
- Body composition - Skeletal muscle mass(6 months)
- Body composition - body fat mass(6 months)
- Happiness(6 months)
- Mental wellbeing(6 months)