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

Overview

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.

Interventions

• Behavioral 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 familia
• 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.

Primary outcome measures

• Montreal Cognitive Assessment [Time frame: Change from baseline to 28 weeks after programme]

Secondary outcome measures (10)

• Frontal Assessment Battery [Time frame: Change from baseline to 28 weeks after programme]
• Fuld Object Memory Evaluation [Time frame: Change from baseline to 28 weeks after programme]
• Modified Fuld Verbal Fluency Test [Time frame: Change from baseline to 28 weeks after programme]
• Social Participation Quesionnaire [Time frame: Change from baseline to 28 weeks after programme]
• Subjective Happiness Scale [Time frame: Change from baseline to 28 weeks after programme]
• DeJong Gierveld Loneliness Scale [Time frame: Change from baseline to 28 weeks after programme]
• Edmonton Frail Scale [Time frame: Change from baseline to 28 weeks after programme]
• Timed Up and Go Test [Time frame: Change from baseline to 28 weeks after programme]
• Handgrip Strength [Time frame: Change from baseline to 28 weeks after programme]
• Six-minute Walk Test [Time frame: Change from baseline to 28 weeks after programme]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Hong Kong · 1 center

• The Hong Kong Polytechnic University — Hong Kong

Publications

• 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 34639644
• 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 32735218
• 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.
• 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 30235949
• 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 27819483
• 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 29881275
• 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 29163146
• 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 24769624

Identifiers

NCT: NCT06791720 · HSEARS20241202003

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗