Choral Singing For the Prevention of Dementia
Primary Purpose
Dementia, Cognitive Decline
Status
Unknown status
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Choral Singing
Health Education Program
Sponsored by
About this trial
This is an interventional prevention trial for Dementia focused on measuring dementia, cognitive decline, choral singing, health education program, randomized controlled trial
Eligibility Criteria
Inclusion Criteria:
- Community-living elderly aged 60 years and above, and
- Subjective cognitive complaints based on self-report, or
- Objective cognitive impairment based on neuropsychological test scores (Z score < 0 and >-1.5), or
- Multiple risk factors of dementia such as family history, depression, etc., and
- Not demented: Clinical Dementia Rating (CDR) global score=0
Exclusion Criteria:
- Any terminal illness, OR
- Stroke, OR
- Aphasia, OR
- Marked hearing impairment, OR
- Participating in another interventional study
Sites / Locations
- TaRA@JPRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention arm
Control arm
Arm Description
Choral Singing
General Health Education Program and Group Activities
Outcomes
Primary Outcome Measures
Changes in cognitive performance
Measured using a composite cognitive test score based on results from a battery of 6 cognitive tests that measures the performance on multiple cognitive domains. The composite cognitive test score (CCTS) will be calculated as the average of Z scores standardised to the baseline mean and standard deviation of trial participants, with higher scores representing better cognitive performance.
Secondary Outcome Measures
Changes in brain structure and function
Measured using brain magnetic resonance imaging (MRI)
Changes in biological markers
Measured using biological sampling
Depressive symptoms
Measured using the Geriatric Depression Scale (GDS-15)
Anxiety symptoms
Measured using the Geriatric Anxiety Inventory (GAI)
Stress
Measured using the Perceived Stress Scale (PSS)
Sleep quality
Measured using the Pittsburgh Sleep Quality Index (PSQI)
Neuropsychiatric symptoms
Measured using the Neuropsychiatric Inventory (NPI)
Changes in Rey Auditory Verbal Learning Test
Measured using Rey Auditory Verbal Learning Test (RAVLT)
Changes in Digit Span
Measured using Digit Span Task
Changes in Block Design
Measured using Block Design Test
Changes in Color Trails
Measured using Color Trails tests
Changes in Symbol Digit Modality
Measured using Symbol Digit Modality Test (SDMT)
Changes in Boston Naming
Measured using Boston Naming Test
Severity of symptoms of dementia
Measured using the Clinical Dementia Rating (CDR)
Changes in Mini-Mental State Examination
Measured using the Mini-Mental State Examination (MMSE)
Changes in Montreal Cognitive Assessment
Measured using the Montreal Cognitive Assessment (MoCA)
Full Information
NCT ID
NCT02919748
First Posted
September 19, 2016
Last Updated
March 29, 2018
Sponsor
National University of Singapore
Collaborators
Agency for Science, Technology and Research, Nanyang Technological University, University of Cambridge, Ministry of Health, Singapore
1. Study Identification
Unique Protocol Identification Number
NCT02919748
Brief Title
Choral Singing For the Prevention of Dementia
Official Title
Choral Singing For the Prevention of Dementia: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
July 2015 (undefined)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National University of Singapore
Collaborators
Agency for Science, Technology and Research, Nanyang Technological University, University of Cambridge, Ministry of Health, Singapore
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To evaluate the efficacy of choral singing in the prevention of dementia and examine the underlying mechanisms using Magnetic Resonance Imaging (MRI) technique and a panel of peripheral biomarkers in venous blood and urine. The investigators hypothesize that Choral singing could prevent cognitive decline among community-dwelling elderly who are at high risk of dementia. The underlying neural mechanisms involve the changes in brain structure and function that can be quantified using MRI technique. The changes in cognitive outcomes will be accompanied by observable changes from a panel of carefully selected peripheral biomarkers.
Detailed Description
Cognitive function declines with advancing age and the prevalence and incidence of dementia rises dramatically in later life. Impaired cognitive function limits one's ability to work, live and socialize, and represent a major obstacle for active aging. Data from Asian countries showed a clear role of cognitive function in contributing to functional disability independent of physical health. How to maintain good cognitive health in the later stage of life is an important and challenging question that requires well-founded research with good applicability. With no cure for dementia in sight presently, it is vitally important to find effective preventive measures. Candidates and potential avenues for intervention should be carefully evaluated in well-designed randomized controlled trials (RCT). Here the investigators propose choral singing as a novel approach for the prevention of cognitive decline and dementia; the investigators plan to test the hypothesized efficacy in a RCT based on a selected group of senior Singaporeans from the Jurong Area. This proposed research is built on a growing body of research evidence on the role of choral singing in health promotion and psychological wellbeing; and the fact that no trial has tested the potential effectiveness of choral singing in delaying cognitive decline and the onset of dementia.
The plasticity of the brain forms the scientific basis for the potential efficacy of choral singing in preventing cognitive decline and the incidence of dementia. It is well known that participating in various cognitive, social and productive activities is associated with improved cognitive function and lower risk of dementia. The protective effects on cognition may be particularly effective for certain subgroups. For example, analysis of local data showed that among the single and widowed elderly, an increase in social engagement was associated with a lower risk of cognitive impairment: compared with subjects in the lowest tertile of social engagement scores, the adjusted Odds Ratio (OR) of cognitive impairment was 0.50 for subjects in the second or the third tertile.
Data from previous clinical trials support that cognitive training is effective in improving cognitive function or delaying cognitive decline in the elderly. Functional gains from cognitive training have been reported to last up to five years, with a meta-analysis demonstrating that the protective effects of cognitive training on cognition in healthy elderly can persist years after training. In Singapore, a brain-computer interface based cognitive training system showed promise in improving memory and attention in healthy elderly. Specifically, the training led to significant improvement in immediate memory (p = 0.038), visuospatial/constructional (p = 0.014), attention (p = 0.039), and delayed memory (p<0.001) scores. However, cognitive training based on human trainer or brain-computer interface are expensive and hence the applicability as a preventive in real world setting for the general population is largely limited. Participants of such trainings also may not be able to maintain lasting interest and motivation. Given those considerations, relatively cost-effective and captivating methods are urgently needed and we believe choral singing is a promising candidate.
In Singapore, there are more than 200 school choirs. Most universities and tertiary education institutions have choirs developed as an expressive art form. Furthermore, there are numerous church choirs who sing with spiritual passion, and the professional choruses who are selected to sing and to perform. The existing resource can be tapped on in the future for large scale interventional initiative once solid data of its efficacy are produced from rigorously designed clinical studies.
In this collaborative research project that involves experts from multiple disciplines, the investigators propose to conduct a randomized clinical trial to examine the clinical efficacy of choral singing in the prevention of cognitive decline and dementia. As a cognitive stimulating activity, choral singing involves cognitive processes such as attention, memory, executive function and language. As a social activity, choral singing consists of group interactions which cultivate the feeling of being part of a meaningful community. Prior studies have demonstrated that situations and activities involving synchrony with others induces feelings of closeness and affiliation, and bolsters coordination with synchronization partners. Increased prosociality and conformity produced by synchrony may also be applied to other people more generally, even those who were not synchronization partners. Moreover, synchrony and affiliative orientations also share a bi-directional relationship, such that individuals who are more prone to prosocial tendencies are more likely to synchronize with others. As a physical exercise, choral singing requires the involvement of more than 100 muscles; it helps to improve lung function and circulation, promotes superior posture, and boost balance and resistance. Choral singing also requires the choristers to cooperate with each other, the discipline of listening to blend with fellow singers and need persistently hard work to stay on par with the level of other singers. All the above may contribute to long term cognitive benefits of choral singing.
Although theoretically plausible, the effectiveness of choral singing in preventing cognitive decline and dementia has not been studied scientifically. This proposed study will fill an important knowledge gap. The investigators aim to produce firm data on two year efficacy of choral singing in preventing cognitive decline and this will form the evidence base for further research and future interventional initiative.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia, Cognitive Decline
Keywords
dementia, cognitive decline, choral singing, health education program, randomized controlled trial
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
360 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention arm
Arm Type
Experimental
Arm Description
Choral Singing
Arm Title
Control arm
Arm Type
Active Comparator
Arm Description
General Health Education Program and Group Activities
Intervention Type
Other
Intervention Name(s)
Choral Singing
Intervention Description
Weekly sessions at 1 hour of choral singing.
Intervention Type
Other
Intervention Name(s)
Health Education Program
Intervention Description
Weekly session at 1 hour of health education talk and group activities
Primary Outcome Measure Information:
Title
Changes in cognitive performance
Description
Measured using a composite cognitive test score based on results from a battery of 6 cognitive tests that measures the performance on multiple cognitive domains. The composite cognitive test score (CCTS) will be calculated as the average of Z scores standardised to the baseline mean and standard deviation of trial participants, with higher scores representing better cognitive performance.
Time Frame
Baseline, 1 year, 2 year
Secondary Outcome Measure Information:
Title
Changes in brain structure and function
Description
Measured using brain magnetic resonance imaging (MRI)
Time Frame
Baseline, 1 year, 2 year
Title
Changes in biological markers
Description
Measured using biological sampling
Time Frame
Baseline, 1 year, 2 year
Title
Depressive symptoms
Description
Measured using the Geriatric Depression Scale (GDS-15)
Time Frame
Baseline, 6 month, 1 year, 2 year
Title
Anxiety symptoms
Description
Measured using the Geriatric Anxiety Inventory (GAI)
Time Frame
Baseline, 6 month, 1 year, 2 year
Title
Stress
Description
Measured using the Perceived Stress Scale (PSS)
Time Frame
Baseline, 6 month, 1 year, 2 year
Title
Sleep quality
Description
Measured using the Pittsburgh Sleep Quality Index (PSQI)
Time Frame
Baseline, 6 month, 1 year, 2 year
Title
Neuropsychiatric symptoms
Description
Measured using the Neuropsychiatric Inventory (NPI)
Time Frame
Baseline, 6 month, 1 year, 2 year.
Title
Changes in Rey Auditory Verbal Learning Test
Description
Measured using Rey Auditory Verbal Learning Test (RAVLT)
Time Frame
Baseline, 1 year, 2 year
Title
Changes in Digit Span
Description
Measured using Digit Span Task
Time Frame
Baseline, 1 year, 2 year
Title
Changes in Block Design
Description
Measured using Block Design Test
Time Frame
Baseline, 1 year, 2 year
Title
Changes in Color Trails
Description
Measured using Color Trails tests
Time Frame
Baseline, 1 year, 2 year
Title
Changes in Symbol Digit Modality
Description
Measured using Symbol Digit Modality Test (SDMT)
Time Frame
Baseline, 1 year, 2 year
Title
Changes in Boston Naming
Description
Measured using Boston Naming Test
Time Frame
Baseline, 1 year, 2 year
Title
Severity of symptoms of dementia
Description
Measured using the Clinical Dementia Rating (CDR)
Time Frame
Baseline, 1 year, 2 year
Title
Changes in Mini-Mental State Examination
Description
Measured using the Mini-Mental State Examination (MMSE)
Time Frame
Baseline, 6 month, 1 year, 2 year
Title
Changes in Montreal Cognitive Assessment
Description
Measured using the Montreal Cognitive Assessment (MoCA)
Time Frame
Baseline, 6 month, 1 year, 2 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Community-living elderly aged 60 years and above, and
Subjective cognitive complaints based on self-report, or
Objective cognitive impairment based on neuropsychological test scores (Z score < 0 and >-1.5), or
Multiple risk factors of dementia such as family history, depression, etc., and
Not demented: Clinical Dementia Rating (CDR) global score=0
Exclusion Criteria:
Any terminal illness, OR
Stroke, OR
Aphasia, OR
Marked hearing impairment, OR
Participating in another interventional study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lei Feng, Medicine
Phone
65-67723491
Email
pcmfl@nus.edu.sg
First Name & Middle Initial & Last Name or Official Title & Degree
Elisabeth Ow, Nursing
Phone
65-67910134
Email
pcmokte@nus.edu.sg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lei Feng, Medicine
Organizational Affiliation
National University of Singapore
Official's Role
Principal Investigator
Facility Information:
Facility Name
TaRA@JP
City
Singapore
ZIP/Postal Code
648886
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elisabeth Ow, Nursing
Phone
65-67910134
Email
pcmokte@nus.edu.sg
First Name & Middle Initial & Last Name & Degree
Lei Feng, MD, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
21941656
Citation
Feng L, Ng TP, He Y, Li C, Kua EH, Zhang M. Physical Health and Cognitive Function Independently Contributed to Functional Disability among Chinese Older Adults: Data from Two Asian Metropolises. J Aging Res. 2011;2011:960848. doi: 10.4061/2011/960848. Epub 2011 Sep 14.
Results Reference
background
PubMed Identifier
25473404
Citation
Feng L, Ng XT, Yap P, Li J, Lee TS, Hakansson K, Kua EH, Ng TP. Marital Status and Cognitive Impairment among Community-Dwelling Chinese Older Adults: The Role of Gender and Social Engagement. Dement Geriatr Cogn Dis Extra. 2014 Oct 14;4(3):375-84. doi: 10.1159/000358584. eCollection 2014 Sep.
Results Reference
background
PubMed Identifier
26360390
Citation
Wu DX, Feng L, Yao SQ, Tian XF, Mahendran R, Kua EH. The early dementia prevention programme in Singapore. Lancet Psychiatry. 2014 Jun;1(1):9-11. doi: 10.1016/S2215-0366(14)70233-0. Epub 2014 Jun 4. No abstract available.
Results Reference
background
PubMed Identifier
30042673
Citation
Tan J, Tsakok FHM, Ow EK, Lanskey B, Lim KSD, Goh LG, Tan CH, Cheah IK, Larbi A, Foo R, Loh M, Wong CKY, Suckling J, Li J, Mahendran R, Kua EH, Feng L. Study Protocol for a Randomized Controlled Trial of Choral Singing Intervention to Prevent Cognitive Decline in At-Risk Older Adults Living in the Community. Front Aging Neurosci. 2018 Jul 10;10:195. doi: 10.3389/fnagi.2018.00195. eCollection 2018.
Results Reference
derived
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Choral Singing For the Prevention of Dementia
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