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

NCT03980392 | Completed DMC

• 1 other identifier: HI18C0479
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 6

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.

Conditions

Mild Cognitive Impairment; Aged

Keywords

prevention; dementia; intervention; mild cognitive impairment

Outcome Measures

Primary Outcomes (3)

• retention rate (percent) of the participants

  Retention rate in each intervention group

  6 months

• compliance (percent)

  Compliance to the protocol in each intervention group

  6 months

• Change of cognition

  Repeatable Battery for the Assessment of Neuropsychological Status (sum, range 40-160) / Higher scores mean better cognition.

  Change at 6 months from baseline

Secondary Outcomes (14)

• Change of global cognition

  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 subjective memory complaints

  Change at 6 months from baseline

• Change of memory complaints

  Change at 6 months from baseline

Study Arms (3)

Facility-based Intervention

EXPERIMENTAL

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).

Other: Multidomain intervention program

Home-based Intervention

EXPERIMENTAL

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.

Other: Multidomain intervention program

Controls

NO INTERVENTION

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

Interventions

Multidomain intervention program OTHER

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

Facility-based Intervention; Home-based Intervention

Eligibility Criteria

• Age: 60 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 60-79
• 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
• 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

You may not qualify if:

• Major psychiatric illness such as major depressive disorders
• Dementia
• 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

Sponsors & Collaborators

• Inha University Hospital: lead
• Korea Health Industry Development Institute: collaborator

Study Sites (6)

Chonnam National University Hospital

Gwangju, South Korea

Location

Inha Univeristy Hospital

Incheon, 400-711, South Korea

Location

Dong-A University Hospital

Pusan, South Korea

Location

Bobath Memorial Hospital

Seongnam, South Korea

Location

Ewha Womans University Mokdong Hospital

Seoul, South Korea

Location

Ajou University Hospital

Suwon, South Korea

Location

Related Publications (2)

• 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.

  PMID: 36805537 DERIVED

• 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.

  PMID: 36313025 DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction; Dementia

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Jee Hyang Jeong, MD, PhD

  Ewha Womans University Hospital

  PRINCIPAL INVESTIGATOR

• So Young Moon, MD, PhD

  Ajou University Hospital, Neurology

  PRINCIPAL INVESTIGATOR

• Chang Hyung Hong, MD, PhD

  Ajou University Hospital, Psychiatry

  PRINCIPAL INVESTIGATOR

• Hae Ri Na, MD, PhD

  Bobath Memorial Hospital

  PRINCIPAL INVESTIGATOR

• Kyung Won Park, MD, PhD

  Dong-A University Hospital

  PRINCIPAL INVESTIGATOR

• Byung Chae Kim, MD, PhD

  Chonnam National University Hospital

  PRINCIPAL INVESTIGATOR

• Yoo Kyoung Park, PhD

  Kyunghee University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Independent raters are blinded to the group of participants.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor Seong Hye Choi

Model Details: They will be randomly allocated to facility-based multidomain intervention group, home-based intervention group, and a regular health advice group (referred to as control group) at a ratio of 1:1:1.

Study Record Dates

• First Submitted: May 28, 2019
• First Posted: June 10, 2019
• Study Start: May 29, 2019
• Primary Completion: February 14, 2020
• Study Completion: February 25, 2020
• Last Updated: March 4, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (6)