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

A Multicenter Randomized Controlled Study to Evaluate the Efficacy of a 24-week Multidomain Intervention Via Face-to-face and Video Communication Platforms in Mild Cognitive Impairment

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.

Study Overview

• Status: Completed
• Conditions: Mild Cognitive Impairment
• Intervention / Treatment: Behavioral: Multidomain intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Busan, Korea, Republic of
    • Dong-A University Hospital
  • Busan, Korea, Republic of
    • Pusan National University Hospital
  • Daejeon, Korea, Republic of
    • Eulji University Hospital
  • Goyang-si, Korea, Republic of
    • Myungji Hospital
  • Gwangju, Korea, Republic of
    • Chonnam University Hospital
  • Incheon, Korea, Republic of, 22332
    • Inha University Hospital
  • Incheon, Korea, Republic of
    • Catholic Kwandong University International St. Mary's Hospital
  • Jeonju, Korea, Republic of
    • Jeonbuk National University Hospital
  • Seongnam, Korea, Republic of
    • CHA Bundang Medical Center
  • Seongnam, Korea, Republic of
    • Bobath Memorial Hospital
  • Seoul, Korea, Republic of
    • Ewha Womans University Mokdong Hospital
  • Seoul, Korea, Republic of
    • Samsung Medical Center
  • Seoul, Korea, Republic of
    • Hanyang University Hospital
  • Seoul, Korea, Republic of
    • Konkuk University Hospital
  • Seoul, Korea, Republic of
    • Ewha Womans Seoul Hospital
  • Suwon, Korea, Republic of
    • Ajou University Hospital
  • Uijeongbu, Korea, Republic of
    • Uijeongbu St. Mary's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 56 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of cognition	Repeatable Battery for the Assessment of Neuropsychological Status (range 40-160). Higher scores indicate better performance.	Change from Baseline at 24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of global cognition	Mini-Mental State Examination (range 0-30). Higher scores indicate better performance.	Change from Baseline at 24 weeks
Change of function	Clinical Dementia Rating scale-Sum of Boxes (range 0-18). Higher scores indicate worse performance.	Change from Baseline at 24 weeks
Change of subjective memory	Prospective and Retrospective Memory Questionnaire (range 16-80). Higher scores indicate worse performance.	Change from Baseline at 24 weeks
Change of depression	Geriatric Depression Scale-15 items (range 0-15). Higher scores indicate worse performance.	Change from Baseline at 24 weeks
Change of quality of life	Quality of life-Alzheimer's disease (range 0-52). Higher scores indicate better performance.	Change from Baseline at 24 weeks
Change of activities of daily living	Bayer Activities of Daily Living (range 1-10). Higher scores indicate worse performance.	Change from Baseline at 24 weeks
Change of nutritional behavior	Nutrition Quotient for elderly (range 0-100). Higher scores indicate better performance.	Change from Baseline at 24 weeks
Change of nutrition	Mini Nutritional Assessment (range 0-14). Higher scores indicate better performance.	Change from Baseline at 24 weeks
Change of motor function	Short Physical Performance Battery (range 0-12). Higher scores indicate better performance.	Change from Baseline at 24 weeks
Change of sleep quality	Pittsburgh Sleep Quality Index (range 0-21). Higher scores indicate worse performance.	Change from Baseline at 24 weeks
Change of motivation	Self Determination Index (SDI). Higher scores of SDI indicate better performance.	Change from Baseline at 24 weeks. Higher scores indicate better performance.

Collaborators and Investigators

• Sponsor: Inha University Hospital
• Investigators: Principal Investigator: Seong Hye Choi, MD, PhD, Inha University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 23, 2021
• Primary Completion (Actual): March 22, 2023
• Study Completion (Actual): March 22, 2023

Study Registration Dates

• First Submitted: August 20, 2021
• First Submitted That Met QC Criteria: August 25, 2021
• First Posted (Actual): August 26, 2021

Study Record Updates

• Last Update Posted (Actual): December 4, 2024
• Last Update Submitted That Met QC Criteria: December 3, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: 2021-06-040

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data that support the findings of this study will be available from the principal investigator upon reasonable request.
• IPD Sharing Time Frame: Data will be available for 2 years since March 2024.
• IPD Sharing Access Criteria: Reasonable request
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No