Choral Singing For the Prevention of Dementia

Sponsor

National University, Singapore (Other)

Overall Status

Unknown status

CT.gov ID

NCT02919748

Collaborator

Agency for Science, Technology and Research (Other), Nanyang Technological University (Other), University of Cambridge (Other), Ministry of Health, Singapore (Other)

360

Enrollment

Location

Arms

Duration (Months)

6.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Dementia Cognitive Decline	Other: Choral Singing Other: Health Education Program	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

360 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

Choral Singing For the Prevention of Dementia: A Randomized Controlled Trial

Study Start Date :

Jul 1, 2015

Anticipated Primary Completion Date :

Dec 1, 2019

Anticipated Study Completion Date :

Dec 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention arm Choral Singing	Other: Choral Singing Weekly sessions at 1 hour of choral singing.
Active Comparator: Control arm General Health Education Program and Group Activities	Other: Health Education Program Weekly session at 1 hour of health education talk and group activities

Arm

Intervention/Treatment

Experimental: Intervention arm

Choral Singing

Other: Choral Singing

Weekly sessions at 1 hour of choral singing.

Active Comparator: Control arm

General Health Education Program and Group Activities

Other: Health Education Program

Weekly session at 1 hour of health education talk and group activities

Outcome Measures

Primary Outcome Measures

Changes in cognitive performance [Baseline, 1 year, 2 year]
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 [Baseline, 1 year, 2 year]
Measured using brain magnetic resonance imaging (MRI)
Changes in biological markers [Baseline, 1 year, 2 year]
Measured using biological sampling
Depressive symptoms [Baseline, 6 month, 1 year, 2 year]
Measured using the Geriatric Depression Scale (GDS-15)
Anxiety symptoms [Baseline, 6 month, 1 year, 2 year]
Measured using the Geriatric Anxiety Inventory (GAI)
Stress [Baseline, 6 month, 1 year, 2 year]
Measured using the Perceived Stress Scale (PSS)
Sleep quality [Baseline, 6 month, 1 year, 2 year]
Measured using the Pittsburgh Sleep Quality Index (PSQI)
Neuropsychiatric symptoms [Baseline, 6 month, 1 year, 2 year.]
Measured using the Neuropsychiatric Inventory (NPI)
Changes in Rey Auditory Verbal Learning Test [Baseline, 1 year, 2 year]
Measured using Rey Auditory Verbal Learning Test (RAVLT)
Changes in Digit Span [Baseline, 1 year, 2 year]
Measured using Digit Span Task
Changes in Block Design [Baseline, 1 year, 2 year]
Measured using Block Design Test
Changes in Color Trails [Baseline, 1 year, 2 year]
Measured using Color Trails tests
Changes in Symbol Digit Modality [Baseline, 1 year, 2 year]
Measured using Symbol Digit Modality Test (SDMT)
Changes in Boston Naming [Baseline, 1 year, 2 year]
Measured using Boston Naming Test
Severity of symptoms of dementia [Baseline, 1 year, 2 year]
Measured using the Clinical Dementia Rating (CDR)
Changes in Mini-Mental State Examination [Baseline, 6 month, 1 year, 2 year]
Measured using the Mini-Mental State Examination (MMSE)
Changes in Montreal Cognitive Assessment [Baseline, 6 month, 1 year, 2 year]
Measured using the Montreal Cognitive Assessment (MoCA)

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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