Multidomain Intervention Via a None-face-to-face Platform in Mild Cognitive Impairment

Not Applicable

• Conditions: Mild Cognitive Impairment
• Interventions: Behavioral: Multidomain intervention

• Registration Number: NCT05301868
• Lead Sponsor: Inha University Hospital

Brief Summary

This study will be done to investigate the feasibility and effectiveness of a 24-week multidomain intervention program consisting of cognitive training, exercise, nutrition management, vascular disease risk factor management, and motivational enhancement on the cognitive function via none-face-to-face platform 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 Mediterranean-DASH Intervention for Neurodegenerative Delay diet (MIND) diet. They will be educated about vascular risk factor management every 2 weeks. 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. All intervention will be administered via tablet personal computer (PC) application at home.

Study Timeline

• Study First Submitted: 2022-03-21
• Study First Submitted QC: 2022-03-21
• Study First Posted: 2022-03-31
• Status Verified: 2022-04
• Study Start: 2022-04-11
• Last Update Submitted: 2022-04-11
• Last Update Posted: 2022-04-13
• Primary Completion: 2023-11-30
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Subjects who completed end-of-study evaluation and participated in the preceding randomized controlled trial (RCT) "Multidomain Interventions Via Face-to-face and Video Communication Platforms in Mild Cognitive Impairment".
• 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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Multidomain intervention	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; (3) physical exercise; (4) nutritional guidance; and (5) motivational training via none-face-to-face tablet PC application (app).

Primary Outcome Measures

Name	Time	Method
Change of cognition	Change from Baseline at 24 weeks	Repeatable Battery for the Assessment of Neuropsychological Status

Secondary Outcome Measures

Name	Time	Method
Change of global cognition	Change from Baseline at 24 weeks	Mini-Mental State Examination (range 0-30). Higher scores indicate better performance.
Change of function	Change from Baseline at 24 weeks	Clinical Dementia Rating scale-Sum of Boxes (range 0-18). Higher scores indicate worse performance.
Change of subjective memory	Change from Baseline at 24 weeks	Prospective and Retrospective Memory Questionnaire (range 16-80). Higher scores indicate worse performance.
Change of depression	Change from Baseline at 24 weeks	Geriatric Depression Scale-15 items (range 0-15). Higher scores indicate worse performance.
Quality of life assessed by the Quality of life-Alzheimer's disease	Change from Baseline at 24 weeks	Quality of life-Alzheimer's disease (range 0-52). Higher scores indicate better performance.
Change of activities of daily living	Change from Baseline at 24 weeks	Bayer Activities of Daily Living (range 1-10). Higher scores indicate worse performance.
Change of nutritional behavior	Change from Baseline at 24 weeks	Nutrition Quotient for elderly (range 0-100). Higher scores indicate better performance.
Change of nutrition	Change from Baseline at 24 weeks	Mini Nutritional Assessment (range 0-14). Higher scores indicate better performance.
Change of motor function	Change from Baseline at 24 weeks	Short Physical Performance Battery (range 0-12). Higher scores indicate better performance.
Sleep quality assessed by the Pittsburgh Sleep Quality Index	Change from Baseline at 24 weeks	Pittsburgh Sleep Quality Index (range 0-21). Higher scores indicate worse performance.
Change of motivation	Change from Baseline at 24 weeks. Higher scores indicate better performance.	Self Determination Index (SDI) (range -66\~66). Higher scores of SDI indicate better performance.

Trial Locations

Locations (4)

Chonnam National University Hospital; 🇰🇷 Gwangju, Korea, Republic of

Inha University Hospital; 🇰🇷 Incheon, Korea, Republic of

Ajou University Hospital; 🇰🇷 Suwon, Korea, Republic of

Ewha Womans Seoul Hospital; 🇰🇷 Seoul, Korea, Republic of