Mild Cognitive ImpairmentEXTENDEDNCT05301868
Multidomain Intervention Via a None-face-to-face Platform in Mild Cognitive Impairment
A study testing Multidomain intervention in people with Mild Cognitive Impairment, run by Inha University Hospital at 4 sites in South Korea.
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… Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- Multidomain intervention
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 4 sitesSouth Korea
- Study dates
- 11 Apr 2022to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
4 sites in 1 country.
Jee Hyang Jeong, MD, PhD contact
South Korea4 sites, 4 recruiting
- Not yet recruiting
Chonnam National University Hospital
Gwangju
Soo Hyun Cho, MD
- Recruiting
Inha University Hospital
Incheon, 22332
Seong Hye Choi, MD
- Not yet recruiting
Ewha Womans Seoul Hospital
Seoul
Jee Hyang Jeong, MD, PhD
- Not yet recruiting
Ajou University Hospital
Suwon
So Young Moon, MD, PhD
About this study
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
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.
Read the 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.
- Conditions
- Mild Cognitive Impairment
- Being tested
- Multidomain intervention
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multidomain interventionBehavioural
Also called multidomain cognitive 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.
| Study group | Role | What they receive |
|---|---|---|
| Multidomain intervention | Experimental | 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). Receives: Behavioral: Multidomain intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of cognition
Repeatable Battery for the Assessment of Neuropsychological Status
Measured: Change from Baseline at 24 weeks
Secondary outcomes (11)
Change of global cognition
Mini-Mental State Examination (range 0-30). Higher scores indicate better performance.
Measured: Change from Baseline at 24 weeks
Change of function
Clinical Dementia Rating scale-Sum of Boxes (range 0-18). Higher scores indicate worse performance.
Measured: Change from Baseline at 24 weeks
Change of subjective memory
Prospective and Retrospective Memory Questionnaire (range 16-80). Higher scores indicate worse performance.
Measured: Change from Baseline at 24 weeks
Change of depression
Geriatric Depression Scale-15 items (range 0-15). Higher scores indicate worse performance.
Measured: Change from Baseline at 24 weeks
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.
Measured: Change from Baseline at 24 weeks
Change of activities of daily living
Bayer Activities of Daily Living (range 1-10). Higher scores indicate worse performance.
Measured: Change from Baseline at 24 weeks
Change of nutritional behavior
Nutrition Quotient for elderly (range 0-100). Higher scores indicate better performance.
Measured: Change from Baseline at 24 weeks
Change of nutrition
Mini Nutritional Assessment (range 0-14). Higher scores indicate better performance.
Measured: Change from Baseline at 24 weeks
Change of motor function
Short Physical Performance Battery (range 0-12). Higher scores indicate better performance.
Measured: Change from Baseline at 24 weeks
Sleep quality assessed by the Pittsburgh Sleep Quality Index
Pittsburgh Sleep Quality Index (range 0-21). Higher scores indicate worse performance.
Measured: Change from Baseline at 24 weeks
Change of motivation
Self Determination Index (SDI) (range -66~66). Higher scores of SDI indicate better performance.
Measured: Change from Baseline at 24 weeks. Higher scores indicate better performance.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start11 Apr 2022
- Primary completion30 Nov 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inha University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seong Hye Choi, MD, Inha University Hospital
- Investigators
- Seong Hye Choi, MD, PhD, Principal investigator, Inha University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05301868
- Sponsor's protocol ID
- 2022-02-009
- Acronym
- EXTENDED
- Status last verified
- Apr 2022
- First submitted
- 21 Mar 2022
- Last updated
- 13 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data that support the findings of this study will be available from the principal investigator upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05301868
- Acronym / sponsor ID
- EXTENDED / 2022-02-009
- Conditions
- Mild Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Inha University HospitalUniversity, hospital or other
- Study start
- 11 Apr 2022 (actual)
- Primary completion
- 30 Nov 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 31 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multidomain intervention | Experimental | Behavioral: Multidomain interventionThe 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). |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multidomain interventionAlso: multidomain cognitive interventionFor 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. | Behavioural | Multidomain intervention |
Primary outcome
Change of cognition
Time frame: Change from Baseline at 24 weeks
Repeatable Battery for the Assessment of Neuropsychological Status
11 secondary outcomes
Change of global cognition
Time frame: Change from Baseline at 24 weeks
Change of function
Time frame: Change from Baseline at 24 weeks
Change of subjective memory
Time frame: Change from Baseline at 24 weeks
Change of depression
Time frame: Change from Baseline at 24 weeks
Quality of life assessed by the Quality of life-Alzheimer's disease
Time frame: Change from Baseline at 24 weeks
Change of activities of daily living
Time frame: Change from Baseline at 24 weeks
Change of nutritional behavior
Time frame: Change from Baseline at 24 weeks
Change of nutrition
Time frame: Change from Baseline at 24 weeks
Change of motor function
Time frame: Change from Baseline at 24 weeks
Sleep quality assessed by the Pittsburgh Sleep Quality Index
Time frame: Change from Baseline at 24 weeks
Change of motivation
Time frame: Change from Baseline at 24 weeks. Higher scores indicate better performance.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2022.
- Individual participant dataSharing planned: Yes. The data that support the findings of this study will be available from the principal investigator upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jee Hyang Jeong, MD, PhD contact
Seong Hye Choi, MD, PhD principal investigator
Inha University Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multidomain intervention in people with Mild Cognitive Impairment, run by Inha University Hospital at 4 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Seong Hye Choi, MD, PhD (82 32 890 3659, seonghye@inha.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of cognition (time frame: Change from Baseline at 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2022.