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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.
Study design:
- Randomized Control Trial
Participants:
- Community-dwelling older adults with cognitive frailty
Setting:
- Community centres for seniors
Intervention
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)
Feasibility evaluation
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Smart Taiko Drumming Group | Experimental | Smart Taiko Drumming |
|
| Usual Care Waitlist Control Group | No Intervention | Usual care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Smart Taiko Drumming | Behavioral | 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. |
| 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. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Heart rate | Will be monitored for evaluating the intervention process | 6 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Daphne Sze Ki Cheung, PhD | Contact | 27664534 | daphne.cheung@polyu.edu.hk | |
| Daphne Sze Ki Cheung, PhD | Contact | 27664534 | daphne.s.k.cheung@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Daphne Sze Ki Cheung, PhD | The Hong Kong Polytechnic University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| School of Nursing, The Hong Kong Polytechnic University | Recruiting | Hong Kong | Hong Kong |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| D000073496 | Frailty |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D010335 | Pathologic Processes |
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Trained research assistants will collect the data blinded to group assignment.
| 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 |
| D013568 |
| Pathological Conditions, Signs and Symptoms |