Cognitive Impairment Clinical Trial
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.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | June 30, 2025 |
Est. primary completion date | June 30, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 60 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Hong Kong | School of Nursing, The Hong Kong Polytechnic University | Hong Kong |
Lead Sponsor | Collaborator |
---|---|
The Hong Kong Polytechnic University |
Hong Kong,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Heart rate | Will be monitored for evaluating the intervention process | 6 months | |
Primary | 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 | |
Primary | Recruitment rate | The Proportion of eligible people recruited (= proportion of people randomised/proportion of people eligible). | Through study completion, an average of 2 years | |
Primary | 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 | |
Primary | 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 | Safety concerns of the intervention | Any adverse events during the intervention period | Through study completion, an average of 2 years. | |
Secondary | 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 | |
Secondary | Executive function | Frontal Assessment Battery Total score with the possible score from 0 - 18, higher scores indicating better performance | 6 months | |
Secondary | Memory | Fuld Object Memory Evaluation Total Storage score ranges from 0 -50, with a higher score indicate better memory. | 6 months | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Handgrip strength | To be measured with a hand-held Jamar Hand Dynamometer | 6 months | |
Secondary | Functional capacity and endurance | Six-Minute-Walk-Test. The longer distance walked indicates better functional capacity and endurance. | 6 months | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Frailty status | FRAIL scale with the possible score range from 0 - 5. Higher score refers to higher frailty. | 6 months | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Body composition - body mass index | Body weight in kg is divided by square of body height | 6 months | |
Secondary | 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 | |
Secondary | Body composition - percent body fat. | InBody S10, Korea except those with contradictions, such as wearing a pacemaker. | 6 months |
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