A Pilot Study for Efficacy of Cognitive and Physical Training in Patients With Mild Cognitive Impairment

NCT06355973 | Not Yet Recruiting

• 1 other identifier: 2024-01-061
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is to find out the effectiveness of cognitive and physical function training for patients with mild cognitive impairment. It is for the prevention and treatment of dementia in the future. randomized, Pilot Study.

Conditions

Patients With Mild Cognitive Impairment (MCI)

Outcome Measures

Primary Outcomes (1)

• Montreal Cognitive Assessment (MoCA)

  K-MoCA is a measure of memory loss or other symptoms of cognitive decline. It includes 30 questions and a task that takes about 12 minutes to complete. The score can range from 0 to 30. A score of 26 or higher is considered normal.

  screening - 6 weeks - 3 months

Secondary Outcomes (9)

• Korean-Mini Mental Status Examination (K-MMSE)

  Baseline - 6 weeks - 3months

• Clinical Dementia Rating (CDR)

  Baseline - 3months

• Clinical Global Impressions of Change (CGIC)

  Baseline - 6 weeks- 3months

• Instrumental Activities of Daily Living (I-ADL)

  Baseline - 6 weeks- 3months

• Berg Balance Scale (BBS)

  Baseline - 6 weeks- 3months

Study Arms (2)

Using tablets and workbooks.

EXPERIMENTAL

Using tablets and workbooks Cognitive and physical function training self-programming for 6 weeks.

Device: Using tablets and workbooks cognitive function.; Device: self-programming of physical function training.

Only self-programming of physical function training.

EXPERIMENTAL

Only self-programming of physical function training is provided Implemented for 6 weeks.

Device: self-programming of physical function training.

Interventions

Using tablets and workbooks cognitive function. DEVICE

Cognitive training programs corresponding to memory, attention, time and space, and orientation are conducted for 35 to 60 minutes.

Using tablets and workbooks.

self-programming of physical function training. DEVICE

The fitness program consisting of stretching, muscle strength, coordination, and aerobic exercise lasts 20 to 30 minutes, and additional 3-4 times/mainly 30 to 40 minutes of aerobic exercise.

Only self-programming of physical function training.; Using tablets and workbooks.

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• men and women aged 60 or older
• A person who falls within the abnormal range of the Montreal Cognitive Assessment (MoCA) test
• a person who can independently carry out daily life
• If the subject or legal representative voluntarily decides to participate and agrees in writing to comply with the precautions after hearing and fully understanding the detailed explanation of this clinical study

You may not qualify if:

• A person diagnosed with Alzheimer's dementia or other causes (stroke, brain tumor, cerebral palsy, dementia, Parkinson's disease, etc.)
• A person with unstable cardiovascular system, digestive system, respiratory system, endocrine system, etc. and poor general condition
• Patients who have participated in other treatment clinical studies or who have participated in other treatment clinical studies within the last 30 days
• Other cases where the researcher determines that participation in this clinical study is not appropriate

Sponsors & Collaborators

• MinYoung Kim, MD, PhD: lead

Study Officials

• MinYoung Kim, MD, PhD

  CHA Bundang Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

MinYoung Kim, MD, PhD

CONTACT

+82317806281; kmin@cha.ac.kr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor-Investigator

Study Record Dates

• First Submitted: March 19, 2024
• First Posted: April 10, 2024
• Study Start: April 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: April 10, 2024

Record last verified: 2024-04