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

Mild Cognitive Impairment Clinical Trial

— EXTENDED  

Official title:

A Multicenter Clinical Study to Evaluate the Efficacy and Feasibility of a 24-week Multidomain Intervention Via a None-face-to-face Platform in Mild Cognitive Impairment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05301868
• Other study ID #: 2022-02-009
• Status: Recruiting
• Phase: N/A
• Start date: April 11, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: April 2022
• Source: Inha University Hospital
• Contact: Seong Hye Choi, MD, PhD
• Phone: 82 32 890 3659
• Email: seonghye[@]inha.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2023
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Mild Cognitive Impairment

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Chonnam National University Hospital	Gwangju
Korea, Republic of	Inha University Hospital	Incheon
Korea, Republic of	Ewha Womans Seoul Hospital	Seoul
Korea, Republic of	Ajou University Hospital	Suwon

Sponsors (1)

Lead Sponsor	Collaborator
Inha University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of cognition	Repeatable Battery for the Assessment of Neuropsychological Status	Change from Baseline at 24 weeks
Secondary	Change of global cognition	Mini-Mental State Examination (range 0-30). Higher scores indicate better performance.	Change from Baseline at 24 weeks
Secondary	Change of function	Clinical Dementia Rating scale-Sum of Boxes (range 0-18). Higher scores indicate worse performance.	Change from Baseline at 24 weeks
Secondary	Change of subjective memory	Prospective and Retrospective Memory Questionnaire (range 16-80). Higher scores indicate worse performance.	Change from Baseline at 24 weeks
Secondary	Change of depression	Geriatric Depression Scale-15 items (range 0-15). Higher scores indicate worse performance.	Change from Baseline at 24 weeks
Secondary	Quality of life assessed by the Quality of life-Alzheimer's disease	Quality of life-Alzheimer's disease (range 0-52). Higher scores indicate better performance.	Change from Baseline at 24 weeks
Secondary	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
Secondary	Change of nutritional behavior	Nutrition Quotient for elderly (range 0-100). Higher scores indicate better performance.	Change from Baseline at 24 weeks
Secondary	Change of nutrition	Mini Nutritional Assessment (range 0-14). Higher scores indicate better performance.	Change from Baseline at 24 weeks
Secondary	Change of motor function	Short Physical Performance Battery (range 0-12). Higher scores indicate better performance.	Change from Baseline at 24 weeks
Secondary	Sleep quality assessed by the Pittsburgh Sleep Quality Index	Pittsburgh Sleep Quality Index (range 0-21). Higher scores indicate worse performance.	Change from Baseline at 24 weeks
Secondary	Change of motivation	Self Determination Index (SDI) (range -66~66). Higher scores of SDI indicate better performance.	Change from Baseline at 24 weeks. Higher scores indicate better performance.