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

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ClinicalTrials.gov Identifier: NCT03786510
Recruitment Status : Completed
First Posted : December 25, 2018
Last Update Posted : December 25, 2018
Sponsor:
Collaborator:
Seoul Metropolitan Government
Information provided by (Responsible Party):
Seoul National University Hospital

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.

Condition or disease Intervention/treatment Phase
Alzheimer Disease Behavioral: Active control Behavioral: Intensive + Maintenance program Behavioral: Intensive program only Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A single-blinded randomized controlled pilot study
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Pilot Study on the Effectiveness of Multidomain Intervention Program for Reducing Risks of Dementia
Actual Study Start Date : November 1, 2016
Actual Primary Completion Date : July 31, 2017
Actual Study Completion Date : July 31, 2017


Arm Intervention/treatment
Active Comparator: Active control
The control group received Community Center for Dementia's usual care of regular health check-up.
Behavioral: Active control
Control group received a personalized advice on lifestyle modification to prevent dementia and usual care of Community Center for Dementia.

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

Experimental: Intensive program only
The INT only group participated in a 4-week intensive program
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.





Primary Outcome Measures :
  1. Changes from baseline Australian National University Alzheimer's Disease Index (ANU-ADRI) at 4 weeks and 24 week [ Time Frame: baseline (0 week), 4-week, 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 :
  1. Changes from baseline Short Physical Performance Battery (SPPB) at 4 weeks and 24 week [ Time Frame: baseline (0 week), 4-week, 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.

  2. Changes from baseline total score in the CERAD neuropsychological battery at 4 weeks and 24 week [ Time Frame: baseline (0 week), 4-week, 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.

  3. Changes from baseline Color Word Stroop Test (CWST) at 4 weeks and 24 week [ Time Frame: baseline (0 week), 4-week, 24-week ]
    CWST mainly can examine the executive function. There are age-, sex-, and educational year-stratified norms; individuals' z-score can be calculated.

  4. Changes from baseline Seoul-Instrumental Activities of Daily Living (S-IADL) at 4 weeks and 24 week [ Time Frame: baseline (0 week), 4-week, 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.

  5. Changes from baseline EuroQol Five-Dimensional Questionnaire (EQ-5D) at 4 weeks and 24 week [ Time Frame: baseline (0 week), 4-week, 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.

  6. Changes from baseline Motivation to Change Lifestyle and Health Behaviors for Dementia Risk Reduction Scale (MCLHB-DRR) scale at 4 weeks and 24 week [ Time Frame: baseline (0 week), 4-week, 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



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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03786510


Locations
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Korea, Republic of
Seoul National University College of Medicine
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital
Seoul Metropolitan Government

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Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT03786510     History of Changes
Other Study ID Numbers: MDP_AD
First Posted: December 25, 2018    Key Record Dates
Last Update Posted: December 25, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Seoul National University Hospital:
Risk reduction
Community
Older adults
Lifestyle modification

Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders