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

NCT03786510 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2018-12-26

No results posted yet for this study

Summary

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.

Conditions

  • Alzheimer Disease

Interventions

BEHAVIORAL

Active control

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

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

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.

Sponsors & Collaborators

  • Seoul Metropolitan Government

    collaborator OTHER_GOV
  • Seoul National University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-11-01
Primary Completion
2017-07-31
Completion
2017-07-31

Countries

  • South Korea

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03786510 on ClinicalTrials.gov