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

Not Applicable

Completed

• Conditions: Mild Cognitive Impairment; Aged
• Interventions: Other: Multidomain intervention program

• Registration Number: NCT03980392
• Lead Sponsor: Inha University Hospital

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 Timeline

• Study First Submitted: 2019-05-28
• Study Start: 2019-05-29
• Study First Submitted QC: 2019-06-07
• Study First Posted: 2019-06-10
• Primary Completion: 2020-02-14
• Study Completion: 2020-02-25
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-02
• Last Update Posted: 2021-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 152

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Home-based Intervention	Multidomain intervention program	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.
Facility-based Intervention	Multidomain intervention program	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).

Primary Outcome Measures

Name	Time	Method
retention rate (percent) of the participants	6 months	Retention rate in each intervention group
compliance (percent)	6 months	Compliance to the protocol in each intervention group
Change of cognition	Change at 6 months from baseline	Repeatable Battery for the Assessment of Neuropsychological Status (sum, range 40-160) / Higher scores mean better cognition.

Secondary Outcome Measures

Name	Time	Method
Change of memory complaints	Change at 6 months from baseline	Cognitive Complaint Interview (CCI) (sum, range 0-10) / Higher scores mean worse memory.
Change of Quality of life (QOL)	Change at 6 months from baseline	QOL-Alzheimer's disease (sum, rage 0-52) / Higher scores mean better QOL.
Change of balance	Change at 6 months from baseline	Short Physical Performance Battery (sum, range 0-12) / Higher scores mean better physical function.
Adverse event (number of participants)	Up to 24 weeks	adverse event in each group
Change of global cognition	Change at 6 months from baseline	Mini-Mental State Examination (sum, range 0-30) / Higher scores mean better cognition.
Change of subjective memory complaints	Change at 6 months from baseline	Prospective and Retrospective Memory Questionnaire (sum, range 18-80) / Higher scores mean worse memory.
Change of activities of daily livings (ADL)	Change at 6 months from baseline	Bayer-ADL (averaged, rage 1-10) / Higher scores mean worse ADL.
Change of function	Change at 6 months from baseline	Clinical Dementia Rating scale-Sum of Boxes (sum, range 0-18) / Higher scores mean worse function.
Change of depression	Change at 6 months from baseline	Geriatric depression scale-15 items (sum, range 0-15) / Higher scores mean worse emotion.
Change of physical activity	Change at 6 months from baseline	Global Physical Activity Questionnaire (This is not scoring.)
Change of prospective memory	Change at 6 months from baseline	Prospective Memory test (sum, range 0-12) / Higher scores mean better memory.
Change of nutritional status	Change at 6 months from baseline	Mini Nutritional Assessment (sum, range 0-14) / Higher scores mean better nutrition.
Change of nutrition	Change at 6 months from baseline	Nutrition Quotient for Elderly (sum, 0-100) / Higher scores mean better nutrition.
Change of motivation	Change at 6 months from baseline	Motivation Questionnaire subscore 1) Situational Motivation Type Scale (sum, range 4-28) / Higher scores mean better motivation.; subscore 2) Self-efficacy (sum, range 4-20) / Higher scores mean better motivation.

Trial Locations

Locations (6)

Chonnam National University Hospital; 🇰🇷 Gwangju, Korea, Republic of

Inha Univeristy Hospital; 🇰🇷 Incheon, Korea, Republic of

Dong-A University Hospital; 🇰🇷 Pusan, Korea, Republic of

Bobath Memorial Hospital; 🇰🇷 Seongnam, Korea, Republic of

Ewha Womans University Mokdong Hospital; 🇰🇷 Seoul, Korea, Republic of

Ajou University Hospital; 🇰🇷 Suwon, Korea, Republic of