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Completed

NCT Number: NCT03980392

South Korean Study to Prevent Cognitive Impairment and Protect Brain Health Through Lifestyle Intervention

This study evaluates acceptability and efficacy of multidomain intervention program to prevent cognitive impairment and protect brain health in Korean at-risk elderly. A third of participants will receive facility-based intervention for 6 months, a third will receive home-based intervention for 6 months, and a third is waiting list controls.

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Key information

Conditions

Mild Cognitive Impairment Aged Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders

Age range

60 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chonnam National University Hospital, Gwangju, South Korea

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About this study

Despite extensive research in the field of Alzheimer's disease (AD), no treatment has yet been developed to modify the progression of AD. Therefore, it is important to manage vascular and metabolic risk factors, to eat healthy foods, to exercise, and to participate in social activities to prevent dementia. The FINGER study showed that the multi-domain intervention program is effective to prevent cognitive impairment and disability in elderly.

In South Korea, exercise and leisure programs, and brain activity for the elderly also have been conducted in welfare centers and public health centers. However, there are not enough programs that have proven effective in the studies.

So the investigators would like to develop a multi-domain intervention program and investigate applicability and efficacy before a large-scale randomized controlled trial.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Aged 60-79
  • Having at least one among the following dementia risks,
  • hypertension
  • Diabetes Mellitus
  • Dyslipidemia
  • Obesity
  • Abdominal obesity
  • Metabolic syndrome
  • Smoking
  • educational level ≤ 9 years
  • Physical inactivity
  • Social inactivity
  • Independent activities of daily living
  • Mini-Mental State Examination score better than1.5 standard deviations below age and education-adjusted normative means
  • Can read and write Korean
  • 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
  • Substantial cognitive decline
  • Other degenerative 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
  • Unable to participate in exercise program safely
  • Coincident participation in any other intervention trial

Treatment and study plan

Multidomain intervention program

Other

Multidomain intervention program for physical exercise, cognitive training, nutrition, vascular and metabolic risk controls, and motivation

Primary outcomes

  1. retention rate (percent) of the participants

    Time frame: 6 months

    Retention rate in each intervention group

  2. compliance (percent)

    Time frame: 6 months

    Compliance to the protocol in each intervention group

  3. Change of cognition

    Time frame: Change at 6 months from baseline

    Repeatable Battery for the Assessment of Neuropsychological Status (sum, range 40-160) / Higher scores mean better cognition.

Secondary outcomes

  1. Change of global cognition

    Time frame: Change at 6 months from baseline

    Mini-Mental State Examination (sum, range 0-30) / Higher scores mean better cognition.

  2. Change of function

    Time frame: Change at 6 months from baseline

    Clinical Dementia Rating scale-Sum of Boxes (sum, range 0-18) / Higher scores mean worse function.

  3. Change of depression

    Time frame: Change at 6 months from baseline

    Geriatric depression scale-15 items (sum, range 0-15) / Higher scores mean worse emotion.

  4. Change of subjective memory complaints

    Time frame: Change at 6 months from baseline

    Prospective and Retrospective Memory Questionnaire (sum, range 18-80) / Higher scores mean worse memory.

  5. Change of memory complaints

    Time frame: Change at 6 months from baseline

    Cognitive Complaint Interview (CCI) (sum, range 0-10) / Higher scores mean worse memory.

  6. Change of prospective memory

    Time frame: Change at 6 months from baseline

    Prospective Memory test (sum, range 0-12) / Higher scores mean better memory.

  7. Change of Quality of life (QOL)

    Time frame: Change at 6 months from baseline

    QOL-Alzheimer's disease (sum, rage 0-52) / Higher scores mean better QOL.

  8. Change of activities of daily livings (ADL)

    Time frame: Change at 6 months from baseline

    Bayer-ADL (averaged, rage 1-10) / Higher scores mean worse ADL.

  9. Change of nutritional status

    Time frame: Change at 6 months from baseline

    Mini Nutritional Assessment (sum, range 0-14) / Higher scores mean better nutrition.

  10. Change of nutrition

    Time frame: Change at 6 months from baseline

    Nutrition Quotient for Elderly (sum, 0-100) / Higher scores mean better nutrition.

  11. Change of balance

    Time frame: Change at 6 months from baseline

    Short Physical Performance Battery (sum, range 0-12) / Higher scores mean better physical function.

  12. Change of physical activity

    Time frame: Change at 6 months from baseline

    Global Physical Activity Questionnaire (This is not scoring.)

  13. Change of motivation

    Time frame: Change at 6 months from baseline

    Motivation Questionnaire subscore 1) Situational Motivation Type Scale (sum, range 4-28) / Higher scores mean better motivation.

    subscore 2) Self-efficacy (sum, range 4-20) / Higher scores mean better motivation.

  14. Adverse event (number of participants)

    Time frame: Up to 24 weeks

    adverse event in each group

Sponsors and collaborators

Lead sponsor

Inha University Hospital

Other

Collaborators

  • Korea Health Industry Development Institute

Registry information

Official study title

A Randomized Controlled Study to Evaluate Applicability of Korean Multidomain Intervention Program in the South Korean Study to Prevent Cognitive Impairment and Protect Brain Health Through Lifestyle Intervention

Acronym: SUPERBRAIN

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jun 10, 2019
Registry last updated
Mar 4, 2021

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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