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A Study on the Effectiveness of Multidomain Intervention Program for Reducing Risks of Dementia

NCT ID: NCT03786510

Last Updated: 2018-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-01

Study Completion Date

2017-07-31

Brief Summary

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Investigators aimed to examine the feasibility and effectiveness of a multidomain intervention strategy involving intensive and maintenance programs aimed at reducing the risk of Alzheimer's disease (AD) in at-risk older adults. Participants were randomly allocated into three groups: (1) intensive plus maintenance program (INT+MNT group), (2) intensive program only (INT-only group), and (3) active control (control group). There were two study hypotheses: 1) the participants in the 4-week intensive program (INT+MNT and INT-only group) would show reduced dementia risk scores compared to control; and 2) that the participants in the added 20-week maintenance program (INT+MNT group) would show greater improvement in dementia risk scores compared to the INT-only and control groups.

Detailed Description

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OBJECTIVES: To examine the feasibility and effectiveness of a multidomain intervention strategy involving intensive and maintenance programs aimed at reducing the risk of Alzheimer's disease (AD) in at-risk older adults.

DESIGN: A prospective randomized controlled trial with participants assigned to three parallel programs: intensive plus maintenance (INT+MNT), intensive only (INT-only), and active control.

SETTING: A community center for dementia in South Korea.

PARTICIPANTS: Community-dwelling older adults (aged ≥ 60 years) without dementia, but having several risk factors for AD.

MEASUREMENTS: The study subjects participated in a 4-week intensive group-based lifestyle modification program that focused on physical activity, vascular risk factors, dietary habits, cognitive activities, and social engagement. Then, the participants underwent a 20-week maintenance program to consolidate modified habits. Linear mixed models were used to examine the changes in modified Australian National University-Alzheimer's Disease Risk Index (ANU-ADRI) scores in each group. Additional analyses of secondary outcomes, including cognitive function, were also performed.

Conditions

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Alzheimer Disease

Keywords

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Risk reduction Community Older adults Lifestyle modification

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A single-blinded randomized controlled pilot study
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Active control

The control group received Community Center for Dementia's usual care of regular health check-up.

Group Type ACTIVE_COMPARATOR

Active control

Intervention Type BEHAVIORAL

Control group received a personalized advice on lifestyle modification to prevent dementia and usual care of Community Center for Dementia.

Intensive + Maintenance program

The INT+MNT group participated in a 4-week intensive program followed by a 20-week maintenance program

Group Type EXPERIMENTAL

Intensive + Maintenance program

Intervention Type BEHAVIORAL

Both intensive and maintenance program

1. Intensive program The 4-week group-based intensive program was comprised of eight sessions; each session consisted of (1) a 30-min review of the tasks, (2) a 50-min training period, and (3) a 10-min meeting to assign tasks on an individual basis. A study nurse-guided training for modification of vascular risk factors, diet, cognitive and social activity were conducted, And, a physiotherapist conducted an exercise training mainly composed of muscle strengthening and stretching.
2. Maintenance program The allocated study assistants monthly check-up whether participants adhere to the altered habits or not, based on the workbook

Intensive program only

The INT only group participated in a 4-week intensive program

Group Type EXPERIMENTAL

Intensive program only

Intervention Type BEHAVIORAL

Only the intensive program was conducted.

The 4-week group-based intensive program was comprised of eight sessions; each session consisted of (1) a 30-min review of the tasks, (2) a 50-min training period, and (3) a 10-min meeting to assign tasks on an individual basis. A study nurse-guided training for modification of vascular risk factors, diet, cognitive and social activity were conducted, And, a physiotherapist conducted an exercise training mainly composed of muscle strengthening and stretching.

Interventions

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Active control

Control group received a personalized advice on lifestyle modification to prevent dementia and usual care of Community Center for Dementia.

Intervention Type BEHAVIORAL

Intensive + Maintenance program

Both intensive and maintenance program

1. Intensive program The 4-week group-based intensive program was comprised of eight sessions; each session consisted of (1) a 30-min review of the tasks, (2) a 50-min training period, and (3) a 10-min meeting to assign tasks on an individual basis. A study nurse-guided training for modification of vascular risk factors, diet, cognitive and social activity were conducted, And, a physiotherapist conducted an exercise training mainly composed of muscle strengthening and stretching.
2. Maintenance program The allocated study assistants monthly check-up whether participants adhere to the altered habits or not, based on the workbook

Intervention Type BEHAVIORAL

Intensive program only

Only the intensive program was conducted.

The 4-week group-based intensive program was comprised of eight sessions; each session consisted of (1) a 30-min review of the tasks, (2) a 50-min training period, and (3) a 10-min meeting to assign tasks on an individual basis. A study nurse-guided training for modification of vascular risk factors, diet, cognitive and social activity were conducted, And, a physiotherapist conducted an exercise training mainly composed of muscle strengthening and stretching.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Subjects aged 60 years and over with age-, sex-, education-adjusted z-score of the Korean version of mini-mental state examination for dementia screening (MMSE-DS) -1.5 standard deviation and above, but having some risk factors for dementia were included: at least two of following risk factors in a recent year (1) do not exercise with moderate degree more than 3 times a week, (2) do not read books, newspapers or magazine more than once a week; (3) do not meet friends, relatives, or close person more than once a week, (4) have depressed mood or low volition.
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Seoul Metropolitan Government

OTHER_GOV

Sponsor Role collaborator

Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Seoul National University College of Medicine

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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MDP_AD

Identifier Type: -

Identifier Source: org_study_id