A Randomized Controlled Study to Evaluate Applicability of Korean Multidomain Intervention Program in the South Korean Study to Prevent Cognitive Impairment and Protect Brain Health Through Lifestyle Intervention
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Inha University Hospital
- Enrollment
- 152
- Locations
- 6
- Primary Endpoint
- retention rate (percent) of the participants
Study Overview
Brief Summary
This study evaluates acceptability and efficacy of multidomain intervention program to prevent cognitive impairment and protect brain health in Korean at-risk elderly. A third of participants will receive facility-based intervention for 6 months, a third will receive home-based intervention for 6 months, and a third is waiting list controls.
Detailed Description
Despite extensive research in the field of Alzheimer's disease (AD), no treatment has yet been developed to modify the progression of AD. Therefore, it is important to manage vascular and metabolic risk factors, to eat healthy foods, to exercise, and to participate in social activities to prevent dementia. The FINGER study showed that the multi-domain intervention program is effective to prevent cognitive impairment and disability in elderly.
In South Korea, exercise and leisure programs, and brain activity for the elderly also have been conducted in welfare centers and public health centers. However, there are not enough programs that have proven effective in the studies.
So the investigators would like to develop a multi-domain intervention program and investigate applicability and efficacy before a large-scale randomized controlled trial.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Masking Description
Independent raters are blinded to the group of participants.
Eligibility Criteria
- Ages
- 60 Years to 79 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Having at least one among the following dementia risks,
- •hypertension
- •Diabetes Mellitus
- •Dyslipidemia
- •Abdominal obesity
- •Metabolic syndrome
- •educational level ≤ 9 years
- •Physical inactivity
- •Social inactivity
- •Independent activities of daily living
- •Mini-Mental State Examination score better than1.5 standard deviations below age and education-adjusted normative means
- •Can read and write Korean
- •Having a reliable informant who could provide investigators with the requested information.
- •Provide written informed consent
Exclusion Criteria
- •Major psychiatric illness such as major depressive disorders
- •Substantial cognitive decline
- •Other degenerative disease (e.g., Parkinson's disease)
- •Malignancy within 5 years
- •Cardiac stent or revascularization within 1 year
- •Serious or unstable symptomatic cardiovascular disease
- •Other serious or unstable medical disease such as acute or severe asthma, active gastric ulcer, severe liver disease, or severe renal disease
- •Severe loss of vision, hearing, or communicative disability
- •Any conditions preventing cooperation as judged by the study physician
- •Significant laboratory abnormality that may result in cognitive impairment
- •Unable to participate in exercise program safely
- •Coincident participation in any other intervention trial
Arms & Interventions
Facility-based Intervention
A group will consist of 5 or 10 persons depending on the size of the study center. Exercise training will be guided by study exercise therapists at a gym and consist of programs for progressive muscle strength training, aerobic exercise, and exercises to improve postural balance and flexibility using elastic bands, floor plate and chairs (three times per week, 60 min per session).The cognitive training program is a program including tasks to be effective in episodic memory, executive function, attention, working memory, calculation, and visuospatial function (twice per week, 60 min per session). The nutritional intervention is conducted by study nutritionists (three individual sessions and seven group sessions). Management of metabolic and vascular risk factors will include additional meetings with the study nurse (at 0, 4, 8, 16, and 20 weeks), and the study physician (at 0 and 12 weeks). Motivational training is conducted by psychologist (four group session).
Intervention: Multidomain intervention program (Other)
Home-based Intervention
The nutritional intervention, management of metabolic and vascular risk factors, social activity, and motivational training in the home-based intervention are similar to the facility-based intervention. The physical exercise programs consist of one group session (60 min) and two home-based sessions (60 min per session) per week in the first 2 months of the trial. During the remaining months of the 6-month study, participants in the home-based intervention attend a 1-h physical exercise group session per two weeks and two or three exercise sessions (60 min per session) alone at home per week. The cognitive training programs consist of one group session (60 min) and one home-based sessions (60 min per session) per week in the first 2 months of the trial. For the remainder of the 6-month study, participants in the home-based intervention attend a 1-h group cognitive training session per two weeks and one or two cognitive training sessions (60 min per session) alone at home per week.
Intervention: Multidomain intervention program (Other)
Controls
They are waiting list controls. They will receive the multi-domain intervention after this study.
Outcomes
Primary Outcomes
retention rate (percent) of the participants
Time Frame: 6 months
Retention rate in each intervention group
compliance (percent)
Time Frame: 6 months
Compliance to the protocol in each intervention group
Change of cognition
Time Frame: Change at 6 months from baseline
Repeatable Battery for the Assessment of Neuropsychological Status (sum, range 40-160) / Higher scores mean better cognition.
Secondary Outcomes
- Adverse event (number of participants)(Up to 24 weeks)
- Change of memory complaints(Change at 6 months from baseline)
- Change of Quality of life (QOL)(Change at 6 months from baseline)
- Change of balance(Change at 6 months from baseline)
- Change of global cognition(Change at 6 months from baseline)
- Change of subjective memory complaints(Change at 6 months from baseline)
- Change of activities of daily livings (ADL)(Change at 6 months from baseline)
- Change of function(Change at 6 months from baseline)
- Change of depression(Change at 6 months from baseline)
- Change of physical activity(Change at 6 months from baseline)
- Change of prospective memory(Change at 6 months from baseline)
- Change of nutritional status(Change at 6 months from baseline)
- Change of nutrition(Change at 6 months from baseline)
- Change of motivation(Change at 6 months from baseline)
Investigators
Inha University Hospital
Professor Seong Hye Choi
Inha University Hospital