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Completed

NCT Number: NCT05023057

Multidomain Interventions Via Face-to-face and Video Communication Platforms in Mild Cognitive Impairment

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.

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Key information

Conditions

Mild Cognitive Impairment Cognition Disorders Cognitive Dysfunction Mental Disorders Neurocognitive Disorders

Age range

60 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dong-A University Hospital, Busan, South Korea

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Multidomain intervention

Behavioral

For 24 weeks, participants will receive cognitive training using the tablet PC application twice a week, exercise 3 times a week, nutrition education 12 times, anthropometric measurements and alcohol and smoking monitoring every 4 weeks, motivation reinforcement training 4 times.

Primary outcomes

  1. Change of cognition

    Time frame: Change from Baseline at 24 weeks

    Repeatable Battery for the Assessment of Neuropsychological Status (range 40-160). Higher scores indicate better performance.

Secondary outcomes

  1. Change of global cognition

    Time frame: Change from Baseline at 24 weeks

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

  2. Change of function

    Time frame: 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

    Time frame: Change from Baseline at 24 weeks

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

  4. Change of depression

    Time frame: Change from Baseline at 24 weeks

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

  5. Change of quality of life

    Time frame: 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

    Time frame: Change from Baseline at 24 weeks

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

  7. Change of nutritional behavior

    Time frame: Change from Baseline at 24 weeks

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

  8. Change of nutrition

    Time frame: Change from Baseline at 24 weeks

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

  9. Change of motor function

    Time frame: Change from Baseline at 24 weeks

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

  10. Change of sleep quality

    Time frame: Change from Baseline at 24 weeks

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

  11. Change of motivation

    Time frame: Change from Baseline at 24 weeks. Higher scores indicate better performance.

    Self Determination Index (SDI). Higher scores of SDI indicate better performance.

Sponsors and collaborators

Lead sponsor

Inha University Hospital

Other

Registry information

Official study 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

Acronym: SUPERBRAIN

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Aug 26, 2021
Registry last updated
Dec 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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