A Study on the Effectiveness of Multidomain Intervention Program for Reducing Risks of Dementia
|ClinicalTrials.gov Identifier: NCT03786510|
Recruitment Status : Completed
First Posted : December 26, 2018
Last Update Posted : December 26, 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
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|