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
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer Disease||Behavioral: Active control Behavioral: Intensive + Maintenance program Behavioral: Intensive program only||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||32 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||A single-blinded randomized controlled pilot study|
|Masking:||Single (Outcomes Assessor)|
|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|
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
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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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
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
|Korea, Republic of|
|Seoul National University College of Medicine|
|Seoul, Korea, Republic of, 110-744|