Smart Taiko-Drum Playing for Older Adults With Cognitive Frailty

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

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 Overview

• Status: Recruiting
• Conditions: Cognitive Impairment; Frailty
• Intervention / Treatment: Behavioral: Smart Taiko Drumming

Detailed 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

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Daphne Sze Ki Cheung, PhD; Phone Number: 27664534; Email: daphne.cheung@polyu.edu.hk
• Study Contact Backup: Name: Daphne Sze Ki Cheung, PhD; Phone Number: 27664534; Email: daphne.s.k.cheung@gmail.com

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Recruiting
    • School of Nursing, The Hong Kong Polytechnic University
    • Contact: Daphne Cheung, PhD; Phone Number: +852 27664534; Email: daphne.cheung@polyu.edu.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Smart Taiko Drumming Group; Smart Taiko Drumming	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.
No Intervention: Usual Care Waitlist Control Group; Usual care

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart rate	Will be monitored for evaluating the intervention process	6 months

Collaborators and Investigators

• Sponsor: The Hong Kong Polytechnic University
• Investigators: Principal Investigator: Daphne Sze Ki Cheung, PhD, The Hong Kong Polytechnic University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2024
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: September 28, 2023
• First Submitted That Met QC Criteria: November 2, 2023
• First Posted (Actual): November 3, 2023

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 27, 2024
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Motor-Cognitive Training; Cognitive frailty; Drumming
• Additional Relevant MeSH Terms: Pathologic Processes; Frailty
• Other Study ID Numbers: P0046219

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No