NCT02919748

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
360

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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 Start

First participant enrolled

July 1, 2015

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 19, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 29, 2016

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

April 2, 2018

Status Verified

March 1, 2018

Enrollment Period

4.4 years

First QC Date

September 19, 2016

Last Update Submit

March 29, 2018

Conditions

Keywords

dementiacognitive declinechoral singinghealth education programrandomized controlled trial

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline, 1 year, 2 year

Secondary Outcomes (16)

  • Changes in brain structure and function

    Baseline, 1 year, 2 year

  • Changes in biological markers

    Baseline, 1 year, 2 year

  • Depressive symptoms

    Baseline, 6 month, 1 year, 2 year

  • Anxiety symptoms

    Baseline, 6 month, 1 year, 2 year

  • Stress

    Baseline, 6 month, 1 year, 2 year

  • +11 more secondary outcomes

Study Arms (2)

Intervention arm

EXPERIMENTAL

Choral Singing

Other: Choral Singing

Control arm

ACTIVE COMPARATOR

General Health Education Program and Group Activities

Other: Health Education Program

Interventions

Weekly sessions at 1 hour of choral singing.

Intervention arm

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

Control arm

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • Any terminal illness, OR
  • Stroke, OR
  • Aphasia, OR
  • Marked hearing impairment, OR
  • Participating in another interventional study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

TaRA@JP

Singapore, 648886, Singapore

RECRUITING

Related Publications (5)

  • 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.

    PMID: 21941656BACKGROUND
  • 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.

    PMID: 25473404BACKGROUND
  • 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.

    PMID: 26360390BACKGROUND
  • Ng TKS, Lim ZH, Todd M, Sun F, Ray K, Qi X, Guo J, Ye KX, Maier AB, Mahendran R, Lee Gan G, Tsakok M, Kua EH, Feng L. Effects of choral singing on depression and anxiety in older adults: A randomized controlled trial. J Psychiatr Res. 2025 Aug;188:162-168. doi: 10.1016/j.jpsychires.2025.05.061. Epub 2025 May 26.

  • 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.

MeSH Terms

Conditions

DementiaCognitive Dysfunction

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersCognition Disorders

Study Officials

  • Lei Feng, Medicine

    National University of Singapore

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lei Feng, Medicine

CONTACT

Elisabeth Ow, Nursing

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

September 19, 2016

First Posted

September 29, 2016

Study Start

July 1, 2015

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

April 2, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations