Effects of Music-with-Movement on Cognitive and Physical Performance of People with Potentially Reversible Cognitive Frailty: a Randomised Controlled Trial

Not Applicable

Not yet recruiting

• Conditions: Physical Frailty; Mild Cognitive Impairment (MCI); Cognitive Frailty

• Registration Number: NCT06791720
• Lead Sponsor: The Hong Kong Polytechnic University

Brief Summary

This study aims to evaluate the effects of Music-with-Movement Simultaneous Cognitive-Motor Dual-Task Training (MM-SDTT) on cognitive and physical performance in older adults with cognitive frailty coexisting with mild cognitive impairment (MCI) and physical frailty.

Research Questions:

1. Will the treatment group show greater improvement in global cognitive functions than the social control group at Week 16?

2. Will the treatment group show greater improvements in both cognitive, physical performance and psychosocial well-being than the social control group at Weeks 16 and 28?

Methodology:

Participants in the Treatment Group:

* Undergo a 16-week intervention comprising:

1. Once-weekly center-based training supervised by a physical coach

2. Twice-weekly home-based training using provided training videos

Participants in the Social Control Group:

* Engage in once-weekly social gatherings and receive remedial training after data collection is completed.

Detailed Description

There is a need to enhance the well-being of older adults with cognitive frailty, defined as the coexistence of mild cognitive impairment (MCI) and physical frailty. Literature shows that combining physical training with cognitive training is effective to improve the health outcomes of MCI, while whether it is beneficial to those MCI with co-existing physical frailty is unknown.

The proposed 16-week Music-with-Movement Simultaneous Cognitive-Motor Dual-Task Training (MM-SDTT) aims to evaluate its effects on the cognitive and physical performance of older adults with cognitive frailty. The MM-SDTT is designed to engage participants through music with cognitive and physical training. The intervention will include warm-up exercise, rhythmic marching, singing familiar songs, dancing workout, stretching exercise with relaxing music, and cool-down exercise. The intervention protocol has been designed according to the guidelines of the American College of Sports Medicine and evidence of previous music-with-movement intervention research.

The study will recruit older adults aged 60 and above, who live in the community and can walk independently, and also have cognitive frailty. Participants will be randomly assigned to either the treatment group or a social control group. Participants in the treatment group will undergo 16-week MM-SDTT consisting of once-weekly center-based training supervised by a coach and twice-weekly home-based training with provided training videos. The logbook and wearable sensor will be used as tools to monitor and record physical activity. Participants in the social control group will participate in social gatherings once weekly over the 16 weeks without affecting the usual care. The MM-SDTT is expected to improve the cognitive and physical functions of older adults with cognitive frailty.

The protocol aims to evaluate the immediate effects (sixteen weeks after weekly supervised sessions, i.e. on the 16th week) and the mid-term effects (three months when the intervention has been completed, i.e. on the 28th week). Hypotheses include that the treatment group will show greater improvements in global cognitive functions compared to the control group at Week 16, as well as greater enhancements in physical and cognitive performance than the control group at Week 16 and 28.

Overall, this research addresses the research gap in interventions for older adults with cognitive frailty, aiming to provide an evidence-based approach to improve their cognitive and physical health outcomes. The anticipated findings might have significant implications for the development of early-stage interventions and clinical practice that can enhance the quality of life for this vulnerable population.

Study Timeline

• Study First Submitted: 2025-01-19
• Study First Submitted QC: 2025-01-19
• Study First Posted: 2025-01-24
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-11
• Last Update Posted: 2025-02-13
• Study Start: 2025-03-01
• Primary Completion: 2027-04-30
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 113

Inclusion Criteria

• Aged 60 and above;
• Community-dwelling, as defined by living at home and not having stayed in a long-term care facility in the last 12 months as reported by the participants;
• Able to walk independently or with a stick;
• A cutoff value of = 0 in the Physical Activity Readiness Questionnaire for Everyone (PAR-Q+) indicates the participants' physical stability;
• A cutoff score of = 0.5 in the Clinical Dementia Rating indicates participants with Mild Cognitive Impairment (MCI);
• A cutoff score of ≥1 on the FRAIL Scale indicates participants with physical frailty;

Exclusion Criteria

• Is suffering from any critical medical or psychiatric illness;
• Has an uncorrectable visual and/or hearing impairment that hinders the participation;
• Is having the MCI or physical frailty only;
• Is participating in other trials;
• Chronic use of corticosteroids, immunosuppressive drugs, androgen-, estrogen-, or progestin-containing compounds
• Taking psychotropic, antiarrhythmic, or hypnotic medications
• Advised by healthcare professionals (e.g., physicians or physiotherapists) not to participate in moderate-to-vigorous exercises.
• Older adults with special conditions or increased risk of injuries that require substantial adjustment in exercise regime, including those with COPD, renal disease, cancer, etc.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Montreal Cognitive Assessment	Change from baseline to 28 weeks after programme	The Montreal Cognitive Assessment (MoCA) is a test of global cognitive functions. MoCA consists of 8 domains, including attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. The scores range from 0 to 30, with higher scores indicating better cognitive functions.

Secondary Outcome Measures

Name	Time	Method
Frontal Assessment Battery	Change from baseline to 28 weeks after programme	The Frontal Assessment Battery (FAB) is a test of executive functions. It consists of 6 domains, including conceptualization, mental flexibility, programming, sensitivity to interference, inhibitory control, and environmental autonomy, on a 3-point numeric scale. The scores range from 0 to 18 points, with a higher score indicating better executive functioning.
Fuld Object Memory Evaluation	Change from baseline to 28 weeks after programme	The Fuld Object Memory Evaluation (FOME) is a test of memory functions, such as encoding, storage, recalling across five trials, and a delayed recall trial. There are three FOME scores, which include total storage (range from 0-50), total retrieval (range from 0-50), and delayed recall (range from 0-10). Higher total scores refer to better memory functions.
Modified Fuld Verbal Fluency Test	Change from baseline to 28 weeks after programme	The Modified Fuld Verbal Fluency Test (MFVT) is used to test verbal fluency, which is embedded in the FOME as a distraction task. Total scores are the total number of items being named, with higher scores indicating better verbal fluency.
Social Participation Quesionnaire	Change from baseline to 28 weeks after programme	The Social Participation Questionnaire (SPQ) is used to test the level of social participation. It consists of 17 questions including informal social contact, social contact through activities in public spaces, participation in group activities, and participation in community groups, on a 6-point numeric scale from 0 to 5. The scores range from 0 to 85 points, with higher scores indicating better social participation.
Subjective Happiness Scale	Change from baseline to 28 weeks after programme	The Subjective Happiness Scale (SHS) is a 4-item scale of global subjective happiness. Each item is rated on a 7-point Likert scale from 1 to 7, and item #4 is reverse coded. All item scores are averaged to get the total scores which range from 1 to 7 with a higher score indicating greater happiness.
DeJong Gierveld Loneliness Scale	Change from baseline to 28 weeks after programme	The DeJong Gierveld Loneliness Scale (DJGLS) is a 6-item scale of emotional loneliness and social loneliness. On the negatively worded items 1-3, the score of Yes = 1, More or less = 1, and No = 0. On the positively worded items 4-6, the score of Yes = 0, More or less = 1, and No = 1. All item scores are averaged to get the total scores which range from 1 to 6 with a higher score indicating greater loneliness.
Edmonton Frail Scale	Change from baseline to 28 weeks after programme	The Edmonton Frail Scale (EFS) is a test to measure frailty. It consists of 9 questions with multidimensional aspects of frailty, including cognition, general health status, functional independence, social support, medication use, nutrition, mood, and continence. The scores range from 0 to 17, with higher scores indicating more severe frailty.
Six-minute Walk Test	Change from baseline to 28 weeks after programme	The Six-Minute Walk Test (6MWT) measures aerobic fitness and endurance by assessing the distance a participant can walk in six minutes.
Timed Up and Go Test	Change from baseline to 28 weeks after programme	The Timed Up and Go Test (TUG) is a test of physical functional abilities. A shorter duration of completing the test indicates better mobility.
Handgrip Strength	Change from baseline to 28 weeks after programme	Handgrip strength is measured with a hand dynamometer to indicate muscle strength.

Trial Locations

Locations (1)

The Hong Kong Polytechnic University; 🇭🇰 Hong Kong, Hong Kong