Cognitive ImpairmentNCT06115889
Smart Taiko-Drum Playing for Older Adults With Cognitive Frailty
A study testing Smart Taiko Drumming in people with Cognitive Impairment and Frailty, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
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… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Cognitive Impairment, Frailty
- What is being tested?
- Smart Taiko Drumming
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Feb 2024to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
School of Nursing, The Hong Kong Polytechnic University
Hong Kong
Daphne Cheung, PhD, +852 27664534, daphne.cheung@polyu.edu.hk
About this study
Official title: 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.
Read the detailed description
- 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
- Conditions
- Cognitive Impairment, Frailty
- Being tested
- Smart Taiko Drumming
- Keywords
- Cognitive frailty, Motor-Cognitive Training, Drumming
- Medical subject headings
- Cognitive Dysfunction, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smart Taiko DrummingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Smart Taiko Drumming Group | Experimental | Smart Taiko Drumming Receives: Behavioral: Smart Taiko Drumming |
| Usual Care Waitlist Control Group | No intervention | Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)).
Measured: Through study completion, an average of 2 years
Recruitment rate
The Proportion of eligible people recruited (= proportion of people randomised/proportion of people eligible).
Measured: 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?"
Measured: 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).
Measured: Through study completion, an average of 2 years.
Secondary outcomes (17)
Safety concerns of the intervention
Any adverse events during the intervention period
Measured: 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
Measured: 6 months
Executive function
Frontal Assessment Battery Total score with the possible score from 0 - 18, higher scores indicating better performance
Measured: 6 months
Memory
Fuld Object Memory Evaluation Total Storage score ranges from 0 -50, with a higher score indicate better memory.
Measured: 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.
Measured: 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.
Measured: 6 months
Handgrip strength
To be measured with a hand-held Jamar Hand Dynamometer
Measured: 6 months
Functional capacity and endurance
Six-Minute-Walk-Test. The longer distance walked indicates better functional capacity and endurance.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months
Frailty status
FRAIL scale with the possible score range from 0 - 5. Higher score refers to higher frailty.
Measured: 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.
Measured: 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.
Measured: 6 months
Body composition - body mass index
Body weight in kg is divided by square of body height
Measured: 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.
Measured: 6 months
Body composition - percent body fat.
InBody S10, Korea except those with contradictions, such as wearing a pacemaker.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2023
- Study start1 Feb 2024
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daphne Sze Ki Cheung, PhD, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06115889
- Sponsor's protocol ID
- P0046219
- Status last verified
- Sep 2023
- First submitted
- 28 Sep 2023
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smart Taiko-Drum Playing for Older Adults With Cognitive Frailty for Improving Cognitive and Physical Functions: A Randomized Controlled Feasibility Study
- ClinicalTrials.gov ID
- NCT06115889
- Acronym / sponsor ID
- P0046219
- Conditions
- Cognitive Impairment, Frailty
- Keywords
- Cognitive frailty, Motor-Cognitive Training, Drumming
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 3 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Smart Taiko Drumming Group | Experimental | Behavioral: Smart Taiko DrummingSmart Taiko Drumming |
| Usual Care Waitlist Control Group | No intervention | –Usual care |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smart Taiko DrummingParticipants 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. | Behavioural | Smart Taiko Drumming Group |
Primary outcome
Attrition rate
Time frame: 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)).
Recruitment rate
Time frame: 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
Time frame: 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
Time frame: 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).
17 secondary outcomes
Safety concerns of the intervention
Time frame: Through study completion, an average of 2 years.
Overall cognitive function
Time frame: 6 months
Executive function
Time frame: 6 months
Memory
Time frame: 6 months
Verbal fluency
Time frame: 6 months
Mobility and Balance
Time frame: 6 months
Handgrip strength
Time frame: 6 months
Functional capacity and endurance
Time frame: 6 months
Mental wellbeing
Time frame: 6 months
Happiness
Time frame: 6 months
Loneliness
Time frame: 6 months
Frailty status
Time frame: 6 months
Body composition - Body weight
Time frame: 6 months
Body composition - Skeletal muscle mass
Time frame: 6 months
Body composition - body mass index
Time frame: 6 months
Body composition - body fat mass
Time frame: 6 months
Body composition - percent body fat.
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daphne Sze Ki Cheung, PhD principal investigator
The Hong Kong Polytechnic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smart Taiko Drumming in people with Cognitive Impairment and Frailty, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Daphne Sze Ki Cheung, PhD (27664534, daphne.cheung@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Attrition rate (time frame: Through study completion, an average of 2 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.