Back to resultsA Study on the Effectiveness of Multidomain Intervention Program for Reducing Risks of Dementia
Primary Purpose
Alzheimer Disease
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Active control
Intensive + Maintenance program
Intensive program only
Sponsored by
About this trial
This is an interventional prevention trial for Alzheimer Disease focused on measuring Risk reduction, Community, Older adults, Lifestyle modification
Eligibility Criteria
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.
Exclusion Criteria:
- Exclusion criteria were previously diagnosed with dementia or other neurologic disorders (e.g., Parkinson's disease); stroke in a recent year or having significant sequelae of past stroke; major psychiatric disorders (e.g., major depressive disorder) in a recent year; having absolute contraindication to participate in exercise program (e.g., need a wheelchair for mobility). Also, subjects who were already participated in other exercise or cognitive stimulating program in the Community Center for Dementia were excluded in the present study.
Sites / Locations
- Seoul National University College of Medicine
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
Active control
Intensive + Maintenance program
Intensive program only
Arm Description
The control group received Community Center for Dementia's usual care of regular health check-up.
The INT+MNT group participated in a 4-week intensive program followed by a 20-week maintenance program
The INT only group participated in a 4-week intensive program
Outcomes
Primary Outcome Measures
Changes from baseline Australian National University Alzheimer's Disease Index (ANU-ADRI) at 4 weeks and 24 week
The ANU-ADRI was developed based on review and meta-analysis of the literature regarding modifiable risk and protective factors for AD; it is a validated instrument assessing individual risk profiles for AD that combines the odds ratios of risk factors to derive a risk score. The total scores ranged from -18 to 63 for males, and from -18 to 66 for females; higher scores indicated greater risk for AD.
Secondary Outcome Measures
Changes from baseline Short Physical Performance Battery (SPPB) at 4 weeks and 24 week
The SPPB was developed for evaluating lower extremity functioning in older persons. The scores range from 0 to 12; higher scores indicated better performance.
Changes from baseline total score in the CERAD neuropsychological battery at 4 weeks and 24 week
The CERAD neuropsychological battery includes various cognitive domains: memory, language, visuospatial, executive, etc. There are age-, sex-, and educational year-stratified norms; individuals' z-score can be calculated.
Changes from baseline Color Word Stroop Test (CWST) at 4 weeks and 24 week
CWST mainly can examine the executive function. There are age-, sex-, and educational year-stratified norms; individuals' z-score can be calculated.
Changes from baseline Seoul-Instrumental Activities of Daily Living (S-IADL) at 4 weeks and 24 week
The S-IADL includes 15 items in regard with various instrumental activities of daily living. The total scores ranged from 0 to 15; higher scores indicated lower level of daily function.
Changes from baseline EuroQol Five-Dimensional Questionnaire (EQ-5D) at 4 weeks and 24 week
The EQ-5D is consisted of five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The total scores ranged from 5 to 15; higher scores indicated lower quality of life.
Changes from baseline Motivation to Change Lifestyle and Health Behaviors for Dementia Risk Reduction Scale (MCLHB-DRR) scale at 4 weeks and 24 week
The MCLHB-DRR was developed to understand beliefs underpinning the lifestyle and health behavioural changes needed for dementia risk reduction. Seven-factor solution (perceived susceptibility, perceived severity, perceived benefits, perceived barriers, cues to action, general health motivation, self-efficiency) with 27 items were included. The total scores ranged from 0 to 27; higher scores indicate higher motivation for reducing risk of dementia
Full Information
NCT ID
NCT03786510
First Posted
December 17, 2018
Last Updated
December 23, 2018
Sponsor
Seoul National University Hospital
Collaborators
Seoul Metropolitan Government
1. Study Identification
Unique Protocol Identification Number
NCT03786510
Brief Title
A Study on the Effectiveness of Multidomain Intervention Program for Reducing Risks of Dementia
Official Title
A Pilot Study on the Effectiveness of Multidomain Intervention Program for Reducing Risks of Dementia
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
November 1, 2016 (Actual)
Primary Completion Date
July 31, 2017 (Actual)
Study Completion Date
July 31, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seoul National University Hospital
Collaborators
Seoul Metropolitan Government
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease
Keywords
Risk reduction, Community, Older adults, Lifestyle modification
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A single-blinded randomized controlled pilot study
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active control
Arm Type
Active Comparator
Arm Description
The control group received Community Center for Dementia's usual care of regular health check-up.
Arm Title
Intensive + Maintenance program
Arm Type
Experimental
Arm Description
The INT+MNT group participated in a 4-week intensive program followed by a 20-week maintenance program
Arm Title
Intensive program only
Arm Type
Experimental
Arm Description
The INT only group participated in a 4-week intensive program
Intervention Type
Behavioral
Intervention Name(s)
Active control
Intervention Description
Control group received a personalized advice on lifestyle modification to prevent dementia and usual care of Community Center for Dementia.
Intervention Type
Behavioral
Intervention Name(s)
Intensive + Maintenance program
Intervention Description
Both intensive and maintenance program
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.
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
Intervention Name(s)
Intensive program only
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes from baseline Australian National University Alzheimer's Disease Index (ANU-ADRI) at 4 weeks and 24 week
Description
The ANU-ADRI was developed based on review and meta-analysis of the literature regarding modifiable risk and protective factors for AD; it is a validated instrument assessing individual risk profiles for AD that combines the odds ratios of risk factors to derive a risk score. The total scores ranged from -18 to 63 for males, and from -18 to 66 for females; higher scores indicated greater risk for AD.
Time Frame
baseline (0 week), 4-week, 24-week
Secondary Outcome Measure Information:
Title
Changes from baseline Short Physical Performance Battery (SPPB) at 4 weeks and 24 week
Description
The SPPB was developed for evaluating lower extremity functioning in older persons. The scores range from 0 to 12; higher scores indicated better performance.
Time Frame
baseline (0 week), 4-week, 24-week
Title
Changes from baseline total score in the CERAD neuropsychological battery at 4 weeks and 24 week
Description
The CERAD neuropsychological battery includes various cognitive domains: memory, language, visuospatial, executive, etc. There are age-, sex-, and educational year-stratified norms; individuals' z-score can be calculated.
Time Frame
baseline (0 week), 4-week, 24-week
Title
Changes from baseline Color Word Stroop Test (CWST) at 4 weeks and 24 week
Description
CWST mainly can examine the executive function. There are age-, sex-, and educational year-stratified norms; individuals' z-score can be calculated.
Time Frame
baseline (0 week), 4-week, 24-week
Title
Changes from baseline Seoul-Instrumental Activities of Daily Living (S-IADL) at 4 weeks and 24 week
Description
The S-IADL includes 15 items in regard with various instrumental activities of daily living. The total scores ranged from 0 to 15; higher scores indicated lower level of daily function.
Time Frame
baseline (0 week), 4-week, 24-week
Title
Changes from baseline EuroQol Five-Dimensional Questionnaire (EQ-5D) at 4 weeks and 24 week
Description
The EQ-5D is consisted of five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The total scores ranged from 5 to 15; higher scores indicated lower quality of life.
Time Frame
baseline (0 week), 4-week, 24-week
Title
Changes from baseline Motivation to Change Lifestyle and Health Behaviors for Dementia Risk Reduction Scale (MCLHB-DRR) scale at 4 weeks and 24 week
Description
The MCLHB-DRR was developed to understand beliefs underpinning the lifestyle and health behavioural changes needed for dementia risk reduction. Seven-factor solution (perceived susceptibility, perceived severity, perceived benefits, perceived barriers, cues to action, general health motivation, self-efficiency) with 27 items were included. The total scores ranged from 0 to 27; higher scores indicate higher motivation for reducing risk of dementia
Time Frame
baseline (0 week), 4-week, 24-week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Exclusion Criteria:
Exclusion criteria were previously diagnosed with dementia or other neurologic disorders (e.g., Parkinson's disease); stroke in a recent year or having significant sequelae of past stroke; major psychiatric disorders (e.g., major depressive disorder) in a recent year; having absolute contraindication to participate in exercise program (e.g., need a wheelchair for mobility). Also, subjects who were already participated in other exercise or cognitive stimulating program in the Community Center for Dementia were excluded in the present study.
Facility Information:
Facility Name
Seoul National University College of Medicine
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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A Study on the Effectiveness of Multidomain Intervention Program for Reducing Risks of Dementia
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