Clinical trial NCT06791720: Effects of Music-with-Movement on Cognitive and Physical Performance of People With Potentially Reversible Cognitive Frailty: a Randomised Controlled Trial
Official title: Effects of Music-with-Movement (Simultaneous Cognitive-motor Dual-task Training) on Cognitive and Physical Performance of People With Potentially Reversible Cognitive Frailty: a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Physical Frailty
Mild Cognitive Impairment (MCI)
Cognitive Frailty
Keywords: Music-with-Movement
Cognitive-Motor
Dual-Task
Physical Performance
Cognitive Performance
Cogntive Frailty
Intervention
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
Collaborators: name: Deakin University
First posted: 2025-01-24
Enrollment: 113
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A single-blinded, two-arm randomized controlled trial will be adopted to evaluate the effects of the Music-with-Movement Simultaneous Cognitive-Motor Dual-Task Training (MM-SDTT) on the cognitive and physical performance of older adults with cognitive frailty. Participants will be randomized to either the treatment or social control groups at a 1:1 ratio using permuted block randomization with a block size of 2.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Montreal Cognitive Assessment
timeFrame: Change from baseline to 28 weeks after programme
Secondary outcomes:
measure: Frontal Assessment Battery
timeFrame: Change from baseline to 28 weeks after programme
measure: Fuld Object Memory Evaluation
timeFrame: Change from baseline to 28 weeks after programme
measure: Modified Fuld Verbal Fluency Test
timeFrame: Change from baseline to 28 weeks after programme
measure: Social Participation Quesionnaire
timeFrame: Change from baseline to 28 weeks after programme
measure: Subjective Happiness Scale
timeFrame: Change from baseline to 28 weeks after programme
measure: DeJong Gierveld Loneliness Scale
timeFrame: Change from baseline to 28 weeks after programme
measure: Edmonton Frail Scale
timeFrame: Change from baseline to 28 weeks after programme
measure: Timed Up and Go Test
timeFrame: Change from baseline to 28 weeks after programme
measure: Handgrip Strength
timeFrame: Change from baseline to 28 weeks after programme
measure: Six-minute Walk Test
timeFrame: Change from baseline to 28 weeks after programme
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Hong Kong Polytechnic University
Study officials:
affiliation: The Hong Kong Polytechnic University
name: Justina Liu, PhD
role: PRINCIPAL_INVESTIGATOR
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