Skip to content

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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05301868
Acronym
EXTENDED
Enrollment
100
Registered
2022-03-31
Start date
2022-04-11
Completion date
2023-12-31
Last updated
2022-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mild Cognitive Impairment

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.

Interventions

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.

Sponsors

Inha University Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
60 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change of cognitionChange from Baseline at 24 weeksRepeatable Battery for the Assessment of Neuropsychological Status

Secondary

MeasureTime frameDescription
Change of functionChange from Baseline at 24 weeksClinical Dementia Rating scale-Sum of Boxes (range 0-18). Higher scores indicate worse performance.
Change of subjective memoryChange from Baseline at 24 weeksProspective and Retrospective Memory Questionnaire (range 16-80). Higher scores indicate worse performance.
Change of depressionChange from Baseline at 24 weeksGeriatric Depression Scale-15 items (range 0-15). Higher scores indicate worse performance.
Quality of life assessed by the Quality of life-Alzheimer's diseaseChange from Baseline at 24 weeksQuality of life-Alzheimer's disease (range 0-52). Higher scores indicate better performance.
Change of activities of daily livingChange from Baseline at 24 weeksBayer Activities of Daily Living (range 1-10). Higher scores indicate worse performance.
Change of global cognitionChange from Baseline at 24 weeksMini-Mental State Examination (range 0-30). Higher scores indicate better performance.
Change of nutritionChange from Baseline at 24 weeksMini Nutritional Assessment (range 0-14). Higher scores indicate better performance.
Change of motor functionChange from Baseline at 24 weeksShort Physical Performance Battery (range 0-12). Higher scores indicate better performance.
Sleep quality assessed by the Pittsburgh Sleep Quality IndexChange from Baseline at 24 weeksPittsburgh Sleep Quality Index (range 0-21). Higher scores indicate worse performance.
Change of motivationChange from Baseline at 24 weeks. Higher scores indicate better performance.Self Determination Index (SDI) (range -66\ 66). Higher scores of SDI indicate better performance.
Change of nutritional behaviorChange from Baseline at 24 weeksNutrition Quotient for elderly (range 0-100). Higher scores indicate better performance.

Countries

South Korea

Contacts

Primary ContactSeong Hye Choi, MD, PhD
seonghye@inha.ac.kr82 32 890 3659
Backup ContactJee Hyang Jeong, MD, PhD
jjeong@ewha.ac.kr

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026