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Study Protocol for a Randomized Controlled Trial of Choral Singing Intervention to Prevent Cognitive Decline in At-Risk Older Adults Living in the Community.

ABSTRACT: Introduction: This study is a parallel-arm randomized controlled trial evaluating choral singing's efficacy and underlying mechanisms in preventing cognitive decline in at-risk older participants. Methods: Three-hundred and sixty community-dwelling, non-demented older participants are recruited for a 2-year intervention. Inclusion criteria are self-reported cognitive complaints, early cognitive impairment based on neuropsychological test scores or multiple risk factors of dementia. Participants are randomized to either weekly choral singing sessions or general health education. The primary outcome is cognitive performance, measured by a composite cognitive test score (CCTS). Secondary outcomes include depression, anxiety and neuropsychiatric symptoms; perceived stress; sleep quality and severity of dementia symptoms. Underlying mechanisms are examined using blood- and urine-based biomarkers and neuroimaging. Results: Screening began in July 2016. The first group of participants (n = 93) have been recruited. Intervention and control treatments are ongoing and will end in December 2019. Discussion: An evidence-based singing intervention for dementia prevention holds potential for healthcare savings and societal welfare. Trial Registration: NCT02919748, IRB Approval Number: NUS 2508.

SUBMITTER: Tan J

PROVIDER: S-EPMC6048740 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature

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Study Protocol for a Randomized Controlled Trial of Choral Singing Intervention to Prevent Cognitive Decline in At-Risk Older Adults Living in the Community.

Tan Jasmine J Tsakok F H Maurine FHM Ow Elisabeth K EK Lanskey Bernard B Lim Kian Siong Darius KSD Goh Lee Gan LG Tan Chay-Hoon CH Cheah Irwin Kee-Mun IK Larbi Anis A Foo Roger R Loh Marie M Wong Caroline Kai Yun CKY Suckling John J Li Jialiang J Mahendran Rathi R Kua Ee-Heok EH Feng Lei L

Frontiers in aging neuroscience 20180710

<b>Introduction</b>: This study is a parallel-arm randomized controlled trial evaluating choral singing's efficacy and underlying mechanisms in preventing cognitive decline in at-risk older participants. <b>Methods</b>: Three-hundred and sixty community-dwelling, non-demented older participants are recruited for a 2-year intervention. Inclusion criteria are self-reported cognitive complaints, early cognitive impairment based on neuropsychological test scores or multiple risk factors of dementia. ...[more]

PMID: 30042673

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Project description:ObjectiveTo examine the associations between BMI categories and subsequent 3-year cognitive decline among older adults, and to test whether physical activity modifies the associations.MethodsStudy sample included n = 1028 cognitively unimpaired older adults participating in the Étude sur la Santé des Aînés (ESA)-Services longitudinal study and followed 3 years later. Cognitive decline was defined as a decrease of > 3 points in MMSE scores between baseline and follow-up. BMI categories (normal weight (reference), underweight, overweight, obese) were derived from self-reported weight and height. Moderate to vigorous physical activity of ≥20 min (# of times per week) was self-reported. The presence of chronic disorders was ascertained from administrative and self-reported data. Logistic regression analyses were used to study the risk of cognitive decline associated with BMI categories stratified by weekly physical activity (≥140 min), the presence of metabolic, cardiovascular and anxio-depressive disorders.ResultsIn the overall sample, there was no evidence that underweight, overweight, or obesity, as compared to normal weight, was associated with cognitive decline, after adjusting for sociodemographic, lifestyle factors, and comorbidities. Individuals with overweight reporting high physical activity had lower odds of cognitive decline (OR = 0.25, 95% CI = 0.07-0.89), whereas no association was observed in individuals with overweight reporting low physical activity (OR = 0.85, 95% CI = 0.41-1.75). Among participants with metabolic and cardiovascular disorders, individuals with overweight reporting high physical activity had lower odds of cognitive decline (OR = 0.09, 95% CI = 0.01-0.59 and OR = 0.03, 95% CI = 0.01-0.92 respectively), whereas no association was observed in those with low physical activity.ConclusionPhysical activity modifies the association between overweight and cognitive decline in older adults overall, as in those with metabolic and cardiovascular disorders. Results highlight the importance of promoting and encouraging regular physical activity in older adults with overweight as prevention against cognitive decline.

Project description:There are few intervention studies that demonstrated linking social participation to lower risk of cognitive decline. We examined prospectively the protective effect of a community intervention program promoting social participation on the incidence of cognitive disability.The baseline was established in a survey of community-dwelling older people aged 65 years old or more in July 2006 (2793 respondents, response rate 48.5%). The setting was Taketoyo town in Japan, where municipal authorities launched an intervention that was based on the establishment of community-based centers called "salons," where the town's senior residents could congregate and participate in social activities, ranging from arts and crafts, games, and interactive activities with preschool children. Three salons were established in May 2010, and a total of 10 salons were in operation by 2013. We recorded the frequency of salon participation among survey respondents till 2013 and conducted two follow-up surveys (in 2010 and 2013) to collect information about health status and behaviors. The onset of cognitive disability was followed from May 2007 to January 2014. We used the marginal structural models to evaluate the effect of program.The range of prevalence of cognitive disability was from 0.2% to 2.5% during the observation period. The proportion of respondents who participates to salons increased over time to about 11.7%. The frequency of salon participation was protectively associated with cognitive decline, even after adjusting for time-dependent covariates and attrition (odds ratio = 0.73, 95% confidence interval: 0.54-0.99).Our study suggests that operating community salons that encourage social interactions, light physical activity, and cognitive activities among older participants may be effective for preventing cognitive decline. In future studies, we need to understand what sorts of activities (e.g., those involving light physical activity vs. purely intellectual activities) are most effective in maintaining cognitive function.

Project description:BackgroundIncreasing physical activity, improving diet, and performing brain training exercises are associated with reduced cognitive decline in older adults.ObjectiveIn this paper, we describe a feasibility trial of the Active Brains intervention, a web-based digital intervention developed to support older adults to make these 3 healthy behavior changes associated with improved cognitive health. The Active Brains trial is a randomized feasibility trial that will test how accessible, acceptable, and feasible the Active Brains intervention is and the effectiveness of the study procedures that we intend to use in the larger, main trial.MethodsIn the randomized controlled trial (RCT), we use a parallel design. We will be conducting the intervention with 2 populations recruited through GP practices (family practices) in England from 2018 to 2019: older adults with signs of cognitive decline and older adults without any cognitive decline. Trial participants were randomly allocated to 1 of 3 study groups: usual care, the Active Brains intervention, or the Active Brains website plus brief support from a trained coach (over the phone or by email). The main outcomes are performance on cognitive tasks, quality of life (using EuroQol-5D 5 level), Instrumental Activities of Daily Living, and diagnoses of dementia. Secondary outcomes (including depression, enablement, and health care costs) and process measures (including qualitative interviews with participants and supporters) will also be collected. The trial has been approved by the National Health Service Research Ethics Committee (reference 17/SC/0463).ResultsResults will be published in peer-reviewed journals, presented at conferences, and shared at public engagement events. Data collection was completed in May 2020, and the results will be reported in 2021.ConclusionsThe findings of this study will help us to identify and make important changes to the website, the support received, or the study procedures before we progress to our main randomized phase III trial.Trial registrationInternational Standard Randomized Controlled Trial Number 23758980; http://www.isrctn.com/ISRCTN23758980.International registered report identifier (irrid)DERR1-10.2196/18929.

Project description:BACKGROUND:Process evaluation can illuminate barriers and facilitators to intervention implementation as well as the drivers of intervention outcomes. However, few obesity intervention studies have documented process evaluation methods and results. Community-based participatory research (CBPR) requires that process evaluation methods be developed to (a) prioritize community members' power to adapt the program to local needs over strict adherence to intervention protocols, (b) share process evaluation data with implementers to maximize benefit to participants, and (c) ensure partner organizations are not overburdened. Co-designed with low-income parents using CBPR, Communities for Healthy Living (CHL) is a family-centered intervention implemented within Head Start to prevent childhood obesity and promote family well-being. We are currently undertaking a randomized controlled trial to test the effectiveness of CHL in 23 Head Start centers in the greater Boston area. In this protocol paper, we outline an embedded process evaluation designed to monitor intervention adherence and adaptation, support ongoing quality improvement, and examine contextual factors that may moderate intervention implementation and/or effectiveness. METHODS:This mixed methods process evaluation was developed using the Pérez et al. framework for evaluating adaptive interventions and is reported following guidelines outlined by Grant et al. Trained research assistants will conduct structured observations of intervention sessions. Intervention facilitators and recipients, along with Head Start staff, will complete surveys and semi-structured interviews. De-identified data for all eligible children and families will be extracted from Head Start administrative records. Qualitative data will be analyzed thematically. Quantitative and qualitative data will be integrated using triangulation methods to assess intervention adherence, monitor adaptations, and identify moderators of intervention implementation and effectiveness. DISCUSSION:A diverse set of quantitative and qualitative data sources are employed to fully characterize CHL implementation. Simultaneously, CHL's process evaluation will provide a case study on strategies to address the challenges of process evaluation for CBPR interventions. Results from this process evaluation will help to explain variation in intervention implementation and outcomes across Head Start programs, support CHL sustainability and future scale-up, and provide guidance for future complex interventions developed using CBPR. TRIAL REGISTRATION:ClinicalTrials.gov, NCT03334669 . Registered on October 10, 2017.

Dataset Information

Study Protocol for a Randomized Controlled Trial of Choral Singing Intervention to Prevent Cognitive Decline in At-Risk Older Adults Living in the Community.

Publications

Study Protocol for a Randomized Controlled Trial of Choral Singing Intervention to Prevent Cognitive Decline in At-Risk Older Adults Living in the Community.

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