Clinical trial NCT05301868: Multidomain Intervention Via a None-face-to-face Platform in Mild Cognitive Impairment
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mild Cognitive Impairment
Lead sponsor: Inha University Hospital
Sponsor class: OTHER
First posted: 2022-03-31
Enrollment: 100
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Change of cognition
timeFrame: Change from Baseline at 24 weeks
Secondary outcomes:
measure: Change of global cognition
timeFrame: Change from Baseline at 24 weeks
measure: Change of function
timeFrame: Change from Baseline at 24 weeks
measure: Change of subjective memory
timeFrame: Change from Baseline at 24 weeks
measure: Change of depression
timeFrame: Change from Baseline at 24 weeks
measure: Quality of life assessed by the Quality of life-Alzheimer's disease
timeFrame: Change from Baseline at 24 weeks
measure: Change of activities of daily living
timeFrame: Change from Baseline at 24 weeks
measure: Change of nutritional behavior
timeFrame: Change from Baseline at 24 weeks
measure: Change of nutrition
timeFrame: Change from Baseline at 24 weeks
measure: Change of motor function
timeFrame: Change from Baseline at 24 weeks
measure: Sleep quality assessed by the Pittsburgh Sleep Quality Index
timeFrame: Change from Baseline at 24 weeks
measure: Change of motivation
timeFrame: Change from Baseline at 24 weeks. Higher scores indicate better performance.
Other outcomes:
Locations:
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
city: Seoul
country: Korea, Republic of
facility: Ewha Womans Seoul Hospital
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
Study officials:
affiliation: Inha University Hospital
name: Seong Hye Choi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: