Clinical trial NCT03980392: South Korean Study to Prevent Cognitive Impairment and Protect Brain Health Through Lifestyle Intervention
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild Cognitive Impairment
Aged
Keywords: prevention
dementia
intervention
mild cognitive impairment
Lead sponsor: Inha University Hospital
Sponsor class: OTHER
Collaborators: name: Korea Health Industry Development Institute
First posted: 2019-06-10
Enrollment: 152
Sex: ALL
Minimum age (years): 60
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: retention rate (percent) of the participants
timeFrame: 6 months
measure: compliance (percent)
timeFrame: 6 months
measure: Change of cognition
timeFrame: Change at 6 months from baseline
Secondary outcomes:
measure: Change of global cognition
timeFrame: Change at 6 months from baseline
measure: Change of function
timeFrame: Change at 6 months from baseline
measure: Change of depression
timeFrame: Change at 6 months from baseline
measure: Change of subjective memory complaints
timeFrame: Change at 6 months from baseline
measure: Change of memory complaints
timeFrame: Change at 6 months from baseline
measure: Change of prospective memory
timeFrame: Change at 6 months from baseline
measure: Change of Quality of life (QOL)
timeFrame: Change at 6 months from baseline
measure: Change of activities of daily livings (ADL)
timeFrame: Change at 6 months from baseline
measure: Change of nutritional status
timeFrame: Change at 6 months from baseline
measure: Change of nutrition
timeFrame: Change at 6 months from baseline
measure: Change of balance
timeFrame: Change at 6 months from baseline
measure: Change of physical activity
timeFrame: Change at 6 months from baseline
measure: Change of motivation
timeFrame: Change at 6 months from baseline
measure: Adverse event (number of participants)
timeFrame: Up to 24 weeks
Other outcomes:
Locations:
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
city: Incheon
country: Korea, Republic of
facility: Inha Univeristy Hospital
city: Pusan
country: Korea, Republic of
facility: Dong-A University Hospital
city: Seongnam
country: Korea, Republic of
facility: Bobath Memorial Hospital
city: Seoul
country: Korea, Republic of
facility: Ewha Womans University Mokdong Hospital
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
Study officials:
affiliation: Ewha Womans University Hospital
name: Jee Hyang Jeong, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ajou University Hospital, Neurology
name: So Young Moon, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ajou University Hospital, Psychiatry
name: Chang Hyung Hong, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Bobath Memorial Hospital
name: Hae Ri Na, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dong-A University Hospital
name: Kyung Won Park, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Chonnam National University Hospital
name: Byung Chae Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kyunghee University
name: Yoo Kyoung Park, PhD
role: STUDY_DIRECTOR
References:
citation: 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.