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

NCT ID: NCT05301868

Last Updated: 2022-04-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-11
• Study Completion Date: 2023-12-31

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.

Conditions

Mild Cognitive Impairment

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

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

Group Type: EXPERIMENTAL

Multidomain intervention

Intervention Type: BEHAVIORAL

For 24 weeks, participants will receive cognitive training twice a week, exercise 3 times a week, nutrition education 12 times, and education about vascular risk factor management every 2 weeks using the tablet PC application.

Interventions

Multidomain intervention

For 24 weeks, participants will receive cognitive training twice a week, exercise 3 times a week, nutrition education 12 times, and education about vascular risk factor management every 2 weeks using the tablet PC application.

Intervention Type: BEHAVIORAL

Other Intervention Names

multidomain cognitive intervention

Eligibility Criteria

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

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

Chonnam National University Hospital

Gwangju, , South Korea

Site Status: NOT_YET_RECRUITING

Inha University Hospital

Incheon, , South Korea

Site Status: RECRUITING

Ewha Womans Seoul Hospital

Seoul, , South Korea

Site Status: NOT_YET_RECRUITING

Ajou University Hospital

Suwon, , South Korea

Site Status: NOT_YET_RECRUITING

Countries

South Korea

Central Contacts

Seong Hye Choi, MD, PhD

Role: CONTACT

seonghye@inha.ac.kr

82 32 890 3659

Jee Hyang Jeong, MD, PhD

Role: CONTACT

jjeong@ewha.ac.kr

Facility Contacts

Soo Hyun Cho, MD

Role: primary

Seong Hye Choi, MD

Role: primary

Jee Hyang Jeong, MD, PhD

Role: primary

So Young Moon, MD, PhD

Role: primary

Other Identifiers

2022-02-009

Identifier Type: -

Identifier Source: org_study_id