Smart Taiko-Drum Playing for Older Adults With Cognitive Frailty

Cognitive Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06115889
• Other study ID #: P0046219
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2024
• Est. completion date: June 30, 2025

Study information

• Verified date: September 2023
• Source: The Hong Kong Polytechnic University
• Contact: Daphne Sze Ki Cheung, PhD
• Phone: 27664534
• Email: daphne.cheung[@]polyu.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

1. Study design:

• Randomized Control Trial

2. Participants:

• Community-dwelling older adults with cognitive frailty

3. Setting:

• Community centres for seniors

4. 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.

5. Waitlist-control group

• Will receive usual care

6. 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

7. Feasibility evaluation

• recruitment

• retention

• satisfactory survey

• compliance with the survey

• safety

• focus group intervention with participants

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Impairment
• Frailty

Intervention

Behavioral:
• Smart Taiko Drumming
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.

Locations

Country	Name	City	State
Hong Kong	School of Nursing, The Hong Kong Polytechnic University	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Heart rate	Will be monitored for evaluating the intervention process	6 months
Primary	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
Primary	Recruitment rate	The Proportion of eligible people recruited (= proportion of people randomised/proportion of people eligible).	Through study completion, an average of 2 years
Primary	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
Primary	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	Safety concerns of the intervention	Any adverse events during the intervention period	Through study completion, an average of 2 years.
Secondary	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
Secondary	Executive function	Frontal Assessment Battery Total score with the possible score from 0 - 18, higher scores indicating better performance	6 months
Secondary	Memory	Fuld Object Memory Evaluation Total Storage score ranges from 0 -50, with a higher score indicate better memory.	6 months
Secondary	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
Secondary	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
Secondary	Handgrip strength	To be measured with a hand-held Jamar Hand Dynamometer	6 months
Secondary	Functional capacity and endurance	Six-Minute-Walk-Test. The longer distance walked indicates better functional capacity and endurance.	6 months
Secondary	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
Secondary	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
Secondary	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
Secondary	Frailty status	FRAIL scale with the possible score range from 0 - 5. Higher score refers to higher frailty.	6 months
Secondary	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
Secondary	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
Secondary	Body composition - body mass index	Body weight in kg is divided by square of body height	6 months
Secondary	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
Secondary	Body composition - percent body fat.	InBody S10, Korea except those with contradictions, such as wearing a pacemaker.	6 months