Clinical trial NCT05023057: Multidomain Interventions Via Face-to-face and Video Communication Platforms in Mild Cognitive Impairment
Official title: A Multicenter Randomized Controlled Study to Evaluate the Efficacy of a 24-week Multidomain Intervention Via Face-to-face and Video Communication Platforms in Mild Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild Cognitive Impairment
Lead sponsor: Inha University Hospital
Sponsor class: OTHER
First posted: 2021-08-26
Enrollment: 300
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: outcome assessor-blinded, randomized controlled trial
Primary purpose: PREVENTION

Brief summary: This study will be done to investigate the effectiveness of a 24-week multidomain intervention program consisting of cognitive training, exercise, nutrition management, vascular disease risk factor management, social activity, and motivational enhancement on the cognitive function compared to the control group 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 MIND diet. They will also meet the study nurse every 4 weeks for anthropometric measurements and monitoring of smoking and alcohol intake. 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.

Eligibility criteria: Inclusion Criteria:

* 60 to 85 years of age
* Having at least one modifiable dementia risk factor
* Complaints of cognitive decline by a participant or informant
* A performance score that is lower than 1.0 standard deviations below the age-, and education-adjusted normative means for one or more of the delayed recall, naming, visuoconstruction, attention, and executive function tests
* MMSE Z score ≥ - 1.5
* Independent activities of daily living
* 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: Change of quality of life
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: Change of sleep quality
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: Busan
country: Korea, Republic of
facility: Dong-A University Hospital
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Daejeon
country: Korea, Republic of
facility: Eulji University Hospital
city: Goyang-si
country: Korea, Republic of
facility: Myungji Hospital
city: Gwangju
country: Korea, Republic of
facility: Chonnam University Hospital
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
city: Incheon
country: Korea, Republic of
facility: Catholic Kwandong University International St. Mary's Hospital
city: Jeonju
country: Korea, Republic of
facility: Jeonbuk National University Hospital
city: Seongnam
country: Korea, Republic of
facility: Bobath Memorial Hospital
city: Seongnam
country: Korea, Republic of
facility: CHA Bundang Medical Center
city: Seoul
country: Korea, Republic of
facility: Ewha Womans Seoul Hospital
city: Seoul
country: Korea, Republic of
facility: Ewha Womans University Mokdong Hospital
city: Seoul
country: Korea, Republic of
facility: Hanyang University Hospital
city: Seoul
country: Korea, Republic of
facility: Konkuk University Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
city: Uijeongbu
country: Korea, Republic of
facility: Uijeongbu St. Mary's Hospital
Study officials:
affiliation: Inha University Hospital
name: Seong Hye Choi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: