Smart Taiko-Drum Playing for Older Adults With Cognitive Frailty

Study Overview
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Brief Summary
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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.

Detailed Description
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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 - Will receive usual care Health outcomes that will be assessed three times at baseline, during (8th week) and immediate post-intervention (16th week) cognitive functions physical functions mental health physical frailty status body composition Feasibility evaluation recruitment retention satisfactory survey compliance with the survey safety focus group intervention with participants

Official Title
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Smart Taiko-Drum Playing for Older Adults With Cognitive Frailty for Improving Cognitive and Physical Functions: A Randomized Controlled Feasibility Study

Conditions
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Cognitive Impairment, Frailty

Intervention / Treatment
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* Behavioral: Smart Taiko Drumming


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Smart Taiko Drumming Group<br>Smart Taiko Drumming | Behavioral: Smart Taiko Drumming<br>* Participants will play drumming with the developed Smart Taiko Drumming System for 30-45 minutes three times per week for 16 weeks, in addition to usual care.<br>|
| No Intervention: Usual Care Waitlist Control Group<br>Usual care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Attrition rate | 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)). | Through study completion, an average of 2 years | 
| Recruitment rate | The Proportion of eligible people recruited (= proportion of people randomised/proportion of people eligible). | Through study completion, an average of 2 years | 
| Satisfaction to the intervention | Satisfaction questionnaire, including questions of Does the game provide an engaging environment for training?, Do you think the exercise intensity suits you? | Through study completion, an average of 2 years | 
| Intervention Completion Rate | 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). | Through study completion, an average of 2 years. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety concerns of the intervention | Any adverse events during the intervention period | Through study completion, an average of 2 years. | 
| Overall cognitive function | The Hong Kong version of the Montreal Cognitive Assessment with the possible score from 0 - 30, with a higher score indicates better cognition | 6 months | 
| Executive function | Frontal Assessment Battery Total score with the possible score from 0 - 18, higher scores indicating better performance | 6 months | 
| Memory | Fuld Object Memory Evaluation Total Storage score ranges from 0 -50, with a higher score indicate better memory. | 6 months | 
| Verbal fluency | Modified Verbal Fluency Test will be used to assess the verbal fluency, with no highest score. Higher score indicates better verbal fluency. | 6 months | 
| Mobility and Balance | Time Up and Go Test will be used. The test measures how long it takes to stand up, walk a distance of 10 feet, turn, walk back, and sit down again. Shorter time indicate better mobility and balance. | 6 months | 
| Handgrip strength | To be measured with a hand-held Jamar Hand Dynamometer | 6 months | 
| Functional capacity and endurance | Six-Minute-Walk-Test. The longer distance walked indicates better functional capacity and endurance. | 6 months | 
| Mental wellbeing | Hospital Anxiety and Depression Scale is a 14-item measure designed to assess anxiety and depression symptoms. The total score ranges from 0 - 42, with a higher score indicates poorer mental wellbeing. | 6 months | 
| Happiness | Subjective Happiness Scale will be used. The four items will be responded on 7-Likert scale. The total is the average score of the 4-items, ranges from 1 - 7. Higher score is more happy. | 6 months | 
| Loneliness | De Jong Gierveld Loneliness Scale will be used. In this 6-item scale, three statements are made about 'emotional loneliness' and three about 'social loneliness'. Total score ranged from 0-6, with a higher score means higher loneliness. | 6 months | 
| Frailty status | FRAIL scale with the possible score range from 0 - 5. Higher score refers to higher frailty. | 6 months | 
| Body composition - Body weight | Bioelectrical impedance analysis will be used for measuring body composition using the InBody S10, Korea except those with contradictions, such as wearing a pacemaker. | 6 months | 
| Body composition - Skeletal muscle mass | Bioelectrical impedance analysis will be used for measuring body composition using the InBody S10, Korea except those with contradictions, such as wearing a pacemaker. | 6 months | 
| Body composition - body mass index | Body weight in kg is divided by square of body height | 6 months | 
| Body composition - body fat mass | Bioelectrical impedance analysis will be used for measuring body composition using the InBody S10, Korea except those with contradictions, such as wearing a pacemaker. | 6 months | 
| Body composition - percent body fat. | InBody S10, Korea except those with contradictions, such as wearing a pacemaker. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cognitive frailty, Motor-Cognitive Training, Drumming