Clinical trial NCT06115889: Smart Taiko-Drum Playing for Older Adults With Cognitive Frailty
Official title: Smart Taiko-Drum Playing for Older Adults With Cognitive Frailty for Improving Cognitive and Physical Functions: A Randomized Controlled Feasibility Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cognitive Impairment
Frailty
Keywords: Cognitive frailty
Motor-Cognitive Training
Drumming
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2023-11-03
Enrollment: 60
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Eligibility criteria: 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.

Primary outcomes:
measure: Attrition rate
timeFrame: Through study completion, an average of 2 years
measure: Recruitment rate
timeFrame: Through study completion, an average of 2 years
measure: Satisfaction to the intervention
timeFrame: Through study completion, an average of 2 years
measure: Intervention Completion Rate
timeFrame: Through study completion, an average of 2 years.
Secondary outcomes:
measure: Safety concerns of the intervention
timeFrame: Through study completion, an average of 2 years.
measure: Overall cognitive function
timeFrame: 6 months
measure: Executive function
timeFrame: 6 months
measure: Memory
timeFrame: 6 months
measure: Verbal fluency
timeFrame: 6 months
measure: Mobility and Balance
timeFrame: 6 months
measure: Handgrip strength
timeFrame: 6 months
measure: Functional capacity and endurance
timeFrame: 6 months
measure: Mental wellbeing
timeFrame: 6 months
measure: Happiness
timeFrame: 6 months
measure: Loneliness
timeFrame: 6 months
measure: Frailty status
timeFrame: 6 months
measure: Body composition - Body weight
timeFrame: 6 months
measure: Body composition - Skeletal muscle mass
timeFrame: 6 months
measure: Body composition - body mass index
timeFrame: 6 months
measure: Body composition - body fat mass
timeFrame: 6 months
measure: Body composition - percent body fat.
timeFrame: 6 months
Other outcomes:
measure: Heart rate
timeFrame: 6 months
Locations:
city: Hong Kong
country: Hong Kong
facility: School of Nursing, The Hong Kong Polytechnic University
Study officials:
affiliation: The Hong Kong Polytechnic University
name: Daphne Sze Ki Cheung, PhD
role: PRINCIPAL_INVESTIGATOR
References: