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

NCT ID: NCT03980392

Last Updated: 2021-03-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 152 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-29
• Study Completion Date: 2020-02-25

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.

Conditions

Mild Cognitive Impairment; Aged

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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).

Group Type: EXPERIMENTAL

Multidomain intervention program

Intervention Type: OTHER

Multidomain intervention program for physical exercise, cognitive training, nutrition, vascular and metabolic risk controls, and motivation

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.

Group Type: EXPERIMENTAL

Multidomain intervention program

Intervention Type: OTHER

Multidomain intervention program for physical exercise, cognitive training, nutrition, vascular and metabolic risk controls, and motivation

Controls

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Multidomain intervention program

Multidomain intervention program for physical exercise, cognitive training, nutrition, vascular and metabolic risk controls, and motivation

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Korea Health Industry Development Institute

OTHER_GOV

Sponsor Role: collaborator

Inha University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Inha University Hospital

Professor Seong Hye Choi

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Jee Hyang Jeong, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Ewha Womans University Hospital

So Young Moon, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Ajou University Hospital, Neurology

Chang Hyung Hong, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Ajou University Hospital, Psychiatry

Hae Ri Na, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Bobath Memorial Hospital

Kyung Won Park, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Dong-A University Hospital

Byung Chae Kim, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Chonnam National University Hospital

Yoo Kyoung Park, PhD

Role: STUDY_DIRECTOR

Kyunghee University

Locations

Chonnam National University Hospital

Gwangju, , South Korea

Inha Univeristy Hospital

Incheon, , South Korea

Dong-A University Hospital

Pusan, , South Korea

Bobath Memorial Hospital

Seongnam, , South Korea

Ewha Womans University Mokdong Hospital

Seoul, , South Korea

Ajou University Hospital

Suwon, , South Korea

Countries

South Korea

References

Han MH, Lee EH, Park HH, Choi SH, Koh SH. Relationship between telomere shortening and early subjective depressive symptoms and cognitive complaints in older adults. Aging (Albany NY). 2023 Feb 17;15(4):914-931. doi: 10.18632/aging.204533. Epub 2023 Feb 17.

Reference Type: DERIVED

PMID: 36805537 (View on PubMed)

Park HK, Choi SH, Kim S, Park U, Kang SW, Jeong JH, Moon SY, Hong CH, Song HS, Chun BO, Lee SM, Choi M, Park KW, Kim BC, Cho SH, Na HR, Park YK. Functional brain changes using electroencephalography after a 24-week multidomain intervention program to prevent dementia. Front Aging Neurosci. 2022 Oct 12;14:892590. doi: 10.3389/fnagi.2022.892590. eCollection 2022.

Reference Type: DERIVED

PMID: 36313025 (View on PubMed)

Other Identifiers

HI18C0479

Identifier Type: -

Identifier Source: org_study_id