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

NCT ID: NCT06791720

Last Updated: 2025-02-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

113 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-01

Study Completion Date

2027-12-31

Brief Summary

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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

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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.

Conditions

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Physical Frailty Mild Cognitive Impairment (MCI) Cognitive Frailty

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
The researchers who perform the outcome assessment and analysis will be blinded to the group allocation of participants.

Study Groups

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Music-with-Movement Simultaneous Cognitive-Motor Dual-Task Training (MM-SDTT) group

Participants in the treatment group will undergo a 16-week MM-SDTT program, which includes once-weekly center-based sessions and twice-weekly home-based sessions. Center-based sessions will be supervised by an interventionist with a physical fitness background, while participants will have home-based sessions using provided training videos.

Group Type EXPERIMENTAL

music-based cognitive-motor dual-task training/exercise

Intervention Type BEHAVIORAL

Participants is engaged in 4 sessions for each training, including rhythmic marching, singing familiar songs, dance workout with elastic bands and stretching exercise with relaxing music. This combination of physical and cognitive activities aims to improve overall well-being by integrating music and movement, making the exercise both enjoyable and beneficial for mental and physical health. Rhythmic aerobic exercises to music focuses on rhythm and movement accuracy. Listening and singing familiar songs is cognitively stimulating. Dance workout allows strength and endurance training with music. Stretching exercise with relaxing music improves the range of movement in major muscle and tendon groups.

Social Control Group

Participants in the social control group will have social chatting weekly for 45 minutes over 16 weeks, to control the potential social effect of the MM-SDTT on cognitive functions. Remedial MM-SDTT will be delivered to the social control group after the data collection is completed.

Group Type OTHER

Social Gatherings

Intervention Type BEHAVIORAL

Participants in the social control group will have a social gathering at the participating center once weekly over the 16 weeks. They will also continue to receive the usual care offered by the centers, such as social support, and health education.

Interventions

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music-based cognitive-motor dual-task training/exercise

Participants is engaged in 4 sessions for each training, including rhythmic marching, singing familiar songs, dance workout with elastic bands and stretching exercise with relaxing music. This combination of physical and cognitive activities aims to improve overall well-being by integrating music and movement, making the exercise both enjoyable and beneficial for mental and physical health. Rhythmic aerobic exercises to music focuses on rhythm and movement accuracy. Listening and singing familiar songs is cognitively stimulating. Dance workout allows strength and endurance training with music. Stretching exercise with relaxing music improves the range of movement in major muscle and tendon groups.

Intervention Type BEHAVIORAL

Social Gatherings

Participants in the social control group will have a social gathering at the participating center once weekly over the 16 weeks. They will also continue to receive the usual care offered by the centers, such as social support, and health education.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Deakin University

OTHER

Sponsor Role collaborator

The Hong Kong Polytechnic University

OTHER

Sponsor Role lead

Responsible Party

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Dr. Justina Liu Yat Wa

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Justina Liu, PhD

Role: PRINCIPAL_INVESTIGATOR

The Hong Kong Polytechnic University

Locations

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The Hong Kong Polytechnic University

Hong Kong, , Hong Kong

Site Status

Countries

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Hong Kong

Central Contacts

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Justina Liu, PhD

Role: CONTACT

(852) 27664097

Facility Contacts

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Justina Liu, PhD

Role: primary

(852) 2766 4097

References

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Liu JYW, Kwan RYC, Yin YH, Lee PH, Siu JY, Bai X. Enhancing the Physical Activity Levels of Frail Older Adults with a Wearable Activity Tracker-Based Exercise Intervention: A Pilot Cluster Randomized Controlled Trial. Int J Environ Res Public Health. 2021 Sep 30;18(19):10344. doi: 10.3390/ijerph181910344.

Reference Type BACKGROUND
PMID: 34639644 (View on PubMed)

Kwan RY, Lee D, Lee PH, Tse M, Cheung DS, Thiamwong L, Choi KS. Effects of an mHealth Brisk Walking Intervention on Increasing Physical Activity in Older People With Cognitive Frailty: Pilot Randomized Controlled Trial. JMIR Mhealth Uhealth. 2020 Jul 31;8(7):e16596. doi: 10.2196/16596.

Reference Type BACKGROUND
PMID: 32735218 (View on PubMed)

Cheung, D.S.K., et al., Music-with-movement intervention for people with mild/early cognitive impairment: An effectiveness-implementation hybrid cluster randomized controlled trial. Alzheimer's & dementia, 2020. 16: p. n/a.

Reference Type BACKGROUND

Cheung DSK, Lai CKY, Wong FKY, Leung MCP. Is music-with-movement intervention better than music listening and social activities in alleviating agitation of people with moderate dementia? A randomized controlled trial. Dementia (London). 2020 Jul;19(5):1413-1425. doi: 10.1177/1471301218800195. Epub 2018 Sep 20.

Reference Type BACKGROUND
PMID: 30235949 (View on PubMed)

Cheung DSK, Lai CKY, Wong FKY, Leung MCP. The effects of the music-with-movement intervention on the cognitive functions of people with moderate dementia: a randomized controlled trial. Aging Ment Health. 2018 Mar;22(3):306-315. doi: 10.1080/13607863.2016.1251571. Epub 2016 Nov 7.

Reference Type BACKGROUND
PMID: 27819483 (View on PubMed)

Chen YL, Pei YC. Musical dual-task training in patients with mild-to-moderate dementia: a randomized controlled trial. Neuropsychiatr Dis Treat. 2018 May 30;14:1381-1393. doi: 10.2147/NDT.S159174. eCollection 2018.

Reference Type BACKGROUND
PMID: 29881275 (View on PubMed)

Tait JL, Duckham RL, Milte CM, Main LC, Daly RM. Influence of Sequential vs. Simultaneous Dual-Task Exercise Training on Cognitive Function in Older Adults. Front Aging Neurosci. 2017 Nov 7;9:368. doi: 10.3389/fnagi.2017.00368. eCollection 2017.

Reference Type BACKGROUND
PMID: 29163146 (View on PubMed)

Satoh M, Ogawa J, Tokita T, Nakaguchi N, Nakao K, Kida H, Tomimoto H. The effects of physical exercise with music on cognitive function of elderly people: Mihama-Kiho project. PLoS One. 2014 Apr 25;9(4):e95230. doi: 10.1371/journal.pone.0095230. eCollection 2014.

Reference Type BACKGROUND
PMID: 24769624 (View on PubMed)

Murrock CJ, Higgins PA. The theory of music, mood and movement to improve health outcomes. J Adv Nurs. 2009 Oct;65(10):2249-57. doi: 10.1111/j.1365-2648.2009.05108.x.

Reference Type BACKGROUND
PMID: 20568327 (View on PubMed)

Sarkamo T. Cognitive, emotional, and neural benefits of musical leisure activities in aging and neurological rehabilitation: A critical review. Ann Phys Rehabil Med. 2018 Nov;61(6):414-418. doi: 10.1016/j.rehab.2017.03.006. Epub 2017 Apr 29.

Reference Type BACKGROUND
PMID: 28461128 (View on PubMed)

Tam ACY, Chan AWY, Cheung DSK, Ho LYW, Tang ASK, Christensen M, Tse MMY, Kwan RYC. The effects of interventions to enhance cognitive and physical functions in older people with cognitive frailty: a systematic review and meta-analysis. Eur Rev Aging Phys Act. 2022 Aug 24;19(1):19. doi: 10.1186/s11556-022-00299-9.

Reference Type BACKGROUND
PMID: 36002799 (View on PubMed)

Other Identifiers

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HSEARS20241202003

Identifier Type: -

Identifier Source: org_study_id

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