Smart Taiko-Drum Playing for Older Adults With Cognitive Frailty

Sponsor
The Hong Kong Polytechnic University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06115889
Collaborator
(none)
60
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2
19.9
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Smart Taiko Drumming
N/A

Detailed Description

  1. Study design:
  • Randomized Control Trial
  1. Participants:
  • Community-dwelling older adults with cognitive frailty
  1. Setting:
  • Community centres for seniors
  1. 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.

  1. Waitlist-control group
  • Will receive usual care
  1. 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

  1. Feasibility evaluation
  • recruitment

  • retention

  • satisfactory survey

  • compliance with the survey

  • safety

  • focus group intervention with participants

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Masking Description:
Trained research assistants will collect the data blinded to group assignment.
Primary Purpose:
Supportive Care
Official Title:
Smart Taiko-Drum Playing for Older Adults With Cognitive Frailty for Improving Cognitive and Physical Functions: A Randomized Controlled Feasibility Study
Anticipated Study Start Date :
Nov 1, 2023
Anticipated Primary Completion Date :
Jun 30, 2025
Anticipated Study Completion Date :
Jun 30, 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Attrition rate [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)).

  2. Recruitment rate [Through study completion, an average of 2 years]

    The Proportion of eligible people recruited (= proportion of people randomised/proportion of people eligible).

  3. Satisfaction to the intervention [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?"

  4. Intervention Completion Rate [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).

Secondary Outcome Measures

  1. Safety concerns of the intervention [Through study completion, an average of 2 years.]

    Any adverse events during the intervention period

  2. Overall cognitive function [6 months]

    The Hong Kong version of the Montreal Cognitive Assessment with the possible score from 0 - 30, with a higher score indicates better cognition

  3. Executive function [6 months]

    Frontal Assessment Battery Total score with the possible score from 0 - 18, higher scores indicating better performance

  4. Memory [6 months]

    Fuld Object Memory Evaluation Total Storage score ranges from 0 -50, with a higher score indicate better memory.

  5. Verbal fluency [6 months]

    Modified Verbal Fluency Test will be used to assess the verbal fluency, with no highest score. Higher score indicates better verbal fluency.

  6. Mobility and Balance [6 months]

    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.

  7. Handgrip strength [6 months]

    To be measured with a hand-held Jamar Hand Dynamometer

  8. Functional capacity and endurance [6 months]

    Six-Minute-Walk-Test. The longer distance walked indicates better functional capacity and endurance.

  9. Mental wellbeing [6 months]

    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.

  10. Happiness [6 months]

    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.

  11. Loneliness [6 months]

    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.

  12. Frailty status [6 months]

    FRAIL scale with the possible score range from 0 - 5. Higher score refers to higher frailty.

  13. Body composition - Body weight [6 months]

    Bioelectrical impedance analysis will be used for measuring body composition using the InBody S10, Korea except those with contradictions, such as wearing a pacemaker.

  14. Body composition - Skeletal muscle mass [6 months]

    Bioelectrical impedance analysis will be used for measuring body composition using the InBody S10, Korea except those with contradictions, such as wearing a pacemaker.

  15. Body composition - body mass index [6 months]

    Body weight in kg is divided by square of body height

  16. Body composition - body fat mass [6 months]

    Bioelectrical impedance analysis will be used for measuring body composition using the InBody S10, Korea except those with contradictions, such as wearing a pacemaker.

  17. Body composition - percent body fat. [6 months]

    InBody S10, Korea except those with contradictions, such as wearing a pacemaker.

Other Outcome Measures

  1. Heart rate [6 months]

    Will be monitored for evaluating the intervention process

Eligibility Criteria

Criteria

Ages Eligible for Study:
60 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 School of Nursing, The Hong Kong Polytechnic University Hong Kong Hong Kong

Sponsors and Collaborators

  • The Hong Kong Polytechnic University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier:
NCT06115889
Other Study ID Numbers:
  • P0046219
First Posted:
Nov 3, 2023
Last Update Posted:
Nov 3, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by The Hong Kong Polytechnic University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 3, 2023