NCT06791720

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:

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

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
113

participants targeted

Target at P50-P75 for not_applicable

Timeline
21mo left

Started Mar 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress42%
Mar 2025Dec 2027

First Submitted

Initial submission to the registry

January 19, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 24, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2025

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2027

Expected
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

February 13, 2025

Status Verified

February 1, 2025

Enrollment Period

2.2 years

First QC Date

January 19, 2025

Last Update Submit

February 11, 2025

Conditions

Keywords

Music-with-MovementCognitive-MotorDual-TaskPhysical PerformanceCognitive PerformanceCogntive FrailtyIntervention

Outcome Measures

Primary Outcomes (1)

  • Montreal Cognitive Assessment

    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.

    Change from baseline to 28 weeks after programme

Secondary Outcomes (10)

  • Frontal Assessment Battery

    Change from baseline to 28 weeks after programme

  • Fuld Object Memory Evaluation

    Change from baseline to 28 weeks after programme

  • Modified Fuld Verbal Fluency Test

    Change from baseline to 28 weeks after programme

  • Social Participation Quesionnaire

    Change from baseline to 28 weeks after programme

  • Subjective Happiness Scale

    Change from baseline to 28 weeks after programme

  • +5 more secondary outcomes

Study Arms (2)

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

EXPERIMENTAL

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.

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

Social Control Group

OTHER

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.

Behavioral: Social Gatherings

Interventions

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.

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

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.

Social Control Group

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Hong Kong Polytechnic University

Hong Kong, Hong Kong

Location

Related Publications (11)

  • 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.

    PMID: 34639644BACKGROUND
  • 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.

    PMID: 32735218BACKGROUND
  • 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.

    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.

    PMID: 30235949BACKGROUND
  • 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.

    PMID: 27819483BACKGROUND
  • 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.

    PMID: 29881275BACKGROUND
  • 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.

    PMID: 29163146BACKGROUND
  • 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.

    PMID: 24769624BACKGROUND
  • 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.

    PMID: 20568327BACKGROUND
  • 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.

    PMID: 28461128BACKGROUND
  • 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.

    PMID: 36002799BACKGROUND

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Exercise

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Justina Liu, PhD

    The Hong Kong Polytechnic University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The researchers who perform the outcome assessment and analysis will be blinded to the group allocation of participants.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 19, 2025

First Posted

January 24, 2025

Study Start

March 1, 2025

Primary Completion (Estimated)

April 30, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

February 13, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

For confidentiality, the data will be kept anonymous and the information of all participants will be replaced by reference codes. The data will be kept in a locked place and electronic versions will be encrypted, and only be accessible by the researchers. All data will be destroyed within 7 years after the completion of this research.

Locations