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

Sponsor
Inha University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05301868
Collaborator
(none)
100
Enrollment
4
Locations
1
Arm
20.7
Anticipated Duration (Months)
25
Patients Per Site
1.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Multidomain intervention
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
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
Actual Study Start Date :
Apr 11, 2022
Anticipated Primary Completion Date :
Nov 30, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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).

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.
Other Names:
  • multidomain cognitive intervention

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change of cognition [Change from Baseline at 24 weeks]

      Repeatable Battery for the Assessment of Neuropsychological Status

    Secondary Outcome Measures

    1. Change of global cognition [Change from Baseline at 24 weeks]

      Mini-Mental State Examination (range 0-30). Higher scores indicate better performance.

    2. Change of function [Change from Baseline at 24 weeks]

      Clinical Dementia Rating scale-Sum of Boxes (range 0-18). Higher scores indicate worse performance.

    3. Change of subjective memory [Change from Baseline at 24 weeks]

      Prospective and Retrospective Memory Questionnaire (range 16-80). Higher scores indicate worse performance.

    4. Change of depression [Change from Baseline at 24 weeks]

      Geriatric Depression Scale-15 items (range 0-15). Higher scores indicate worse performance.

    5. Quality of life assessed by the Quality of life-Alzheimer's disease [Change from Baseline at 24 weeks]

      Quality of life-Alzheimer's disease (range 0-52). Higher scores indicate better performance.

    6. Change of activities of daily living [Change from Baseline at 24 weeks]

      Bayer Activities of Daily Living (range 1-10). Higher scores indicate worse performance.

    7. Change of nutritional behavior [Change from Baseline at 24 weeks]

      Nutrition Quotient for elderly (range 0-100). Higher scores indicate better performance.

    8. Change of nutrition [Change from Baseline at 24 weeks]

      Mini Nutritional Assessment (range 0-14). Higher scores indicate better performance.

    9. Change of motor function [Change from Baseline at 24 weeks]

      Short Physical Performance Battery (range 0-12). Higher scores indicate better performance.

    10. Sleep quality assessed by the Pittsburgh Sleep Quality Index [Change from Baseline at 24 weeks]

      Pittsburgh Sleep Quality Index (range 0-21). Higher scores indicate worse performance.

    11. Change of motivation [Change from Baseline at 24 weeks. Higher scores indicate better performance.]

      Self Determination Index (SDI) (range -66~66). Higher scores of SDI indicate better performance.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    60 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Chonnam National University Hospital Gwangju Korea, Republic of
    2 Inha University Hospital Incheon Korea, Republic of 22332
    3 Ewha Womans Seoul Hospital Seoul Korea, Republic of
    4 Ajou University Hospital Suwon Korea, Republic of

    Sponsors and Collaborators

    • Inha University Hospital

    Investigators

    • Principal Investigator: Seong Hye Choi, MD, PhD, Inha University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Seong Hye Choi, MD, Professor, Inha University Hospital
    ClinicalTrials.gov Identifier:
    NCT05301868
    Other Study ID Numbers:
    • 2022-02-009
    First Posted:
    Mar 31, 2022
    Last Update Posted:
    Apr 13, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Cognitive Dysfunction

    Study Results

    No Results Posted as of Apr 13, 2022