Multidomain Interventions Via Face-to-face and Video Communication Platforms in Mild Cognitive Impairment

NCT ID: NCT05023057

Last Updated: 2024-12-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-23
• Study Completion Date: 2023-03-22

Brief Summary

This study will be done to investigate the effectiveness of a 24-week multidomain intervention program consisting of cognitive training, exercise, nutrition management, vascular disease risk factor management, social activity, and motivational enhancement on the cognitive function compared to the control group in mild cognitive impairment.

Detailed Description

The physical exercise program will consist of aerobic exercise, exercise to enhance balance and flexibility, muscle-strengthening activities involving major muscle groups, and finger-toe movements. Cognitive training targets the cognitive domains of episodic memory, executive function, attention, working memory, calculation, and visuospatial function. Cognitive training will be conducted using a tablet-based application. Participants will be advised to eat something according to the recommendation of the MIND diet. They will also meet the study nurse every 4 weeks for anthropometric measurements and monitoring of smoking and alcohol intake. The purpose of the motivational enhancement program is to induce, maintain, and strengthen motivation, which is a psychological resource to help maintain dementia prevention activities.

Conditions

Mild Cognitive Impairment

Study Design

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

Study Groups

Multidomain intervention

The participants in the intervention arm will receive all five components of the intervention: (1) monitoring and management of metabolic and vascular risk factors; (2) cognitive training and social activity; (3) physical exercise; (4) nutritional guidance; and (5) motivational training.

Group Type: EXPERIMENTAL

Multidomain intervention

Intervention Type: BEHAVIORAL

For 24 weeks, participants will receive cognitive training using the tablet PC application twice a week, exercise 3 times a week, nutrition education 12 times, anthropometric measurements and alcohol and smoking monitoring every 4 weeks, motivation reinforcement training 4 times.

Control

At baseline, the participants in the control group will meet a study doctor, be prescribed medication when necessary, and receive educational booklets corresponding to their risk factors and a booklet on lifestyle guidelines to prevent dementia. They will receive usual care during the study period and be informed that they could participate in the multidomain intervention program after this study end.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Multidomain intervention

For 24 weeks, participants will receive cognitive training using the tablet PC application twice a week, exercise 3 times a week, nutrition education 12 times, anthropometric measurements and alcohol and smoking monitoring every 4 weeks, motivation reinforcement training 4 times.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 60 to 85 years of age
• Having at least one modifiable dementia risk factor
• Complaints of cognitive decline by a participant or informant
• A performance score that is lower than 1.0 standard deviations below the age-, and education-adjusted normative means for one or more of the delayed recall, naming, visuoconstruction, attention, and executive function tests
• MMSE Z score ≥ - 1.5
• Independent activities of daily living
• Being able to use the tablet PC through education, or having a person who can help a participant use the tablet PC.
• Having a reliable informant who could provide investigators with the requested information
• Provide written informed consent

Exclusion Criteria

• Major psychiatric illness such as major depressive disorders
• Dementia
• Other neurodegenerative 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
• Illiteracy
• Unable to participate in exercise program safely
• Coincident participation in any other intervention trial

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Inha University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Seong Hye Choi, MD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Seong Hye Choi, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Inha University Hospital

Locations

Dong-A University Hospital

Busan, , South Korea

Pusan National University Hospital

Busan, , South Korea

Eulji University Hospital

Daejeon, , South Korea

Myungji Hospital

Goyang-si, , South Korea

Chonnam University Hospital

Gwangju, , South Korea

Inha University Hospital

Incheon, , South Korea

Catholic Kwandong University International St. Mary's Hospital

Incheon, , South Korea

Jeonbuk National University Hospital

Jeonju, , South Korea

Bobath Memorial Hospital

Seongnam, , South Korea

CHA Bundang Medical Center

Seongnam, , South Korea

Ewha Womans Seoul Hospital

Seoul, , South Korea

Ewha Womans University Mokdong Hospital

Seoul, , South Korea

Hanyang University Hospital

Seoul, , South Korea

Konkuk University Hospital

Seoul, , South Korea

Samsung Medical Center

Seoul, , South Korea

Ajou University Hospital

Suwon, , South Korea

Uijeongbu St. Mary's Hospital

Uijeongbu-si, , South Korea

Countries

South Korea

References

Moon SY, Park YK, Jeong JH, Hong CH, Jung J, Na HR, Cho SH, Kim HS, Song HS, Choi M, Ku BD, Moon YS, Han HJ, Hong YJ, Kim EJ, Kim GH, Kim KW, Jang H, Yoon SJ, Kim HJ, Choi SH. South Korean study to prevent cognitive impairment and protect brain health through multidomain interventions via face-to-face and video communication platforms in mild cognitive impairment (SUPERBRAIN-MEET): A randomized controlled trial. Alzheimers Dement. 2025 Feb;21(2):e14517. doi: 10.1002/alz.14517. Epub 2025 Jan 22.

Reference Type: DERIVED

PMID: 39840755 (View on PubMed)

Cho SH, Kang HJ, Park YK, Moon SY, Hong CH, Na HR, Song HS, Choi M, Jeong S, Park KW, Kim HS, Chun BO, Jung J, Jeong JH, Choi SH. SoUth Korean study to PrEvent cognitive impaiRment and protect BRAIN health through Multidomain interventions via facE-to-facE and video communication plaTforms in mild cognitive impairment (SUPERBRAIN-MEET): Protocol for a Multicenter Randomized Controlled Trial. Dement Neurocogn Disord. 2024 Jan;23(1):30-43. doi: 10.12779/dnd.2024.23.1.30. Epub 2024 Jan 29.

Reference Type: DERIVED

PMID: 38362052 (View on PubMed)

Other Identifiers

2021-06-040

Identifier Type: -

Identifier Source: org_study_id