South Korean Study to Prevent Cognitive Impairment and Protect Brain Health Through Lifestyle Intervention (SUPERBRAIN)

Inha University Hospital

Status: Completed

Conditions: Mild Cognitive Impairment; Aged

Treatments: Other: Multidomain intervention program

Study type: Interventional

Funder types: Other

Identifiers

NCT03980392

HI18C0479

Details and patient eligibility

About

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.

Full 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.

Enrollment: 152 patients

Sex: All

Ages: 60 to 79 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Aged 60-79

2. Having at least one among the following dementia risks,

   • hypertension
   • Diabetes Mellitus
   • Dyslipidemia
   • Obesity
   • Abdominal obesity
   • Metabolic syndrome
   • Smoking
   • educational level ≤ 9 years
   • Physical inactivity
   • Social inactivity

3. Independent activities of daily living

4. Mini-Mental State Examination score better than1.5 standard deviations below age and education-adjusted normative means

5. Can read and write Korean

6. Having a reliable informant who could provide investigators with the requested information.

7. Provide written informed consent

Exclusion criteria

1. Major psychiatric illness such as major depressive disorders
2. Dementia
3. Substantial cognitive decline
4. Other degenerative disease (e.g., Parkinson's disease)
5. Malignancy within 5 years
6. Cardiac stent or revascularization within 1 year
7. Serious or unstable symptomatic cardiovascular disease
8. Other serious or unstable medical disease such as acute or severe asthma, active gastric ulcer, severe liver disease, or severe renal disease
9. Severe loss of vision, hearing, or communicative disability
10. Any conditions preventing cooperation as judged by the study physician
11. Significant laboratory abnormality that may result in cognitive impairment
12. Unable to participate in exercise program safely
13. Coincident participation in any other intervention trial

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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152 participants in 3 patient groups

Facility-based Intervention

Experimental group

Description:

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).

Treatment:

Other: Multidomain intervention program

Home-based Intervention

Experimental group

Description:

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.

Treatment:

Other: Multidomain intervention program

Controls

No Intervention group

Description:

They are waiting list controls. They will receive the multi-domain intervention after this study.