NCT06115889

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2024

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 28, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 3, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

February 1, 2024

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

February 28, 2024

Status Verified

September 1, 2023

Enrollment Period

1.4 years

First QC Date

September 28, 2023

Last Update Submit

February 27, 2024

Conditions

Cognitive ImpairmentFrailty

Keywords

Cognitive frailtyMotor-Cognitive TrainingDrumming

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (17)

  • Safety concerns of the intervention

    Through study completion, an average of 2 years.

  • Overall cognitive function

    6 months

  • Executive function

    6 months

  • Memory

    6 months

  • Verbal fluency

    6 months

  • +12 more secondary outcomes

Other Outcomes (1)

  • Heart rate

    6 months

Study Arms (2)

Smart Taiko Drumming Group

EXPERIMENTAL

Smart Taiko Drumming

Behavioral: Smart Taiko Drumming

Usual Care Waitlist Control Group

NO INTERVENTION

Usual care

Interventions

Smart Taiko DrummingBEHAVIORAL

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.

Smart Taiko Drumming Group

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Nursing, The Hong Kong Polytechnic University

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Cognitive DysfunctionFrailty

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Daphne Sze Ki Cheung, PhD

    The Hong Kong Polytechnic University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Daphne Sze Ki Cheung, PhD

CONTACT

27664534daphne.cheung@polyu.edu.hk

Daphne Sze Ki Cheung, PhD

CONTACT

27664534daphne.s.k.cheung@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Trained research assistants will collect the data blinded to group assignment.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 28, 2023

First Posted

November 3, 2023

Study Start

February 1, 2024

Primary Completion

June 30, 2025

Study Completion

June 30, 2025

Last Updated

February 28, 2024

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

HK(1)