Intensive Home-based Complex Training in Elderly

Effect of Cognitive and Physical Function Training in the Elderly

This is a single-arm intervention study aimed at investigating whether a 4-week program of daily cognitive and physical activities, lasting 2-3 hours per day, produces significant changes in functional levels in healthy adults aged 65 and older.

Study Overview

• Status: Completed
• Conditions: Elderly
• Intervention / Treatment: Other: Intensive cognitive and physical training

Detailed Description

Purpose of the Clinical Study The aim of this clinical study is to evaluate the effects of cognitive and physical function training in elderly individuals (including those with subjective cognitive decline) to aid in the development of preventive and therapeutic methods for dementia.

Study Participants -Number of Participants and Basis This is a pilot study, and no formal sample size calculation was performed. The study will include 30 participants.

Clinical Study Procedure and Assessment Visit 1 (Screening) During the screening visit, the researcher will select participants based on the inclusion/exclusion criteria. All study-related assessments will take place after obtaining consent. However, if any assessments were performed within 7 days of the screening visit, those results may be used instead. The following activities will be conducted:

Visit 2 (Baseline Assessment) Baseline assessments will be conducted, and Visit 1 and Visit 2 can be performed on the same day. The following activities will be conducted:

After the baseline assessment, participants will receive self-training materials for a 4-week program, jointly developed by EBS (Korea Educational Broadcasting System) and Bundang CHA Hospital. The cognitive and physical function training program will be conducted five times a week for 40 minutes per session. The effectiveness will be evaluated through baseline assessments, and post-training assessments will be conducted after 4 weeks to analyze the results.

The cognitive and physical training program consists of 25-35 minutes of cognitive training (memory, attention, visuospatial orientation) and 10-15 minutes of physical training (stretching, strength training, coordination, and aerobic exercise). Additionally, participants will be instructed to perform 30-40 minutes of aerobic exercise 3-4 times per week.

Participants will be provided with a self-training log to record whether they performed the exercise and to check adherence.

Visit 3 (Post-training Assessment) After completing the 4-week cognitive and physical training program, post-training assessments will be conducted.

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13609
      • CHA Bundang Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Adults aged 65 years or older.
• Individuals capable of independent daily living (including mobility).
• Individuals who fully understand the study and voluntarily agree to participate, providing written consent.

Exclusion Criteria:

• MMSE score less than 20 (19 or below will be excluded).
• Individuals with neurological conditions such as stroke, brain tumor, cerebral palsy, dementia, or Parkinson's disease.
• Individuals with serious medical conditions (cardiovascular, gastrointestinal, respiratory, endocrine, etc.) that compromise their general health.
• Participants currently involved in other clinical studies or who participated in another clinical trial within the past 30 days.
• Any other conditions deemed inappropriate for study participation by the researcher.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Intervention; Intensive cognitive and physical training

Other: Intensive cognitive and physical training; The cognitive and physical training program consists of 25-35 minutes of cognitive training (memory, attention, visuospatial orientation) and 10-15 minutes of physical training (stretching, strength training, coordination, and aerobic exercise). Additionally, participants will be instructed to perform 30-40 minutes of aerobic exercise 3-4 times per week

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
K-MMSE (Korean Mini-Mental Status Examination)	The Mini-Mental State Examination (MMSE) is a widely used screening tool for assessing cognitive function. It is designed to evaluate different cognitive abilities, including memory, attention, language, orientation, and visuospatial skills. The MMSE consists of a series of questions and tasks, with a maximum score of 30 points.	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
RBANS (Repeatable Battery for the Assessment of Neuropsychological Status)	The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) is a neuropsychological test battery used to evaluate cognitive functioning across multiple domains. It is often employed to assess cognitive decline, dementia, and other conditions that affect memory and cognition. RBANS is designed to be both comprehensive and time-efficient, typically taking around 20-30 minutes to administer.	4 weeks
K-MBI (Korean Version of the Modified Barthel Index)	The Modified Barthel Index (MBI) is a widely used tool to measure a person's ability to perform activities of daily living (ADL) independently. It assesses functional mobility and self-care tasks, which are essential for independent living. The MBI is an adaptation of the original Barthel Index and is commonly used in rehabilitation settings to evaluate the progress of patients recovering from conditions such as stroke, brain injuries, or other impairments that affect physical function.	4 weeks
BBS (Berg Balance Scale)	The Berg Balance Scale (BBS) is a clinical test used to measure balance and assess the risk of falling in individuals, particularly older adults or those with neurological conditions. The test consists of 14 tasks that evaluate both static and dynamic balance, such as standing, sitting, and moving between positions. Each task is scored on a scale from 0 to 4, with a maximum total score of 56. Higher scores indicate better balance and lower fall risk.	4 weeks

Collaborators and Investigators

• Sponsor: Bundang CHA Hospital
• Collaborators: Ministry of Science and ICT; The Korea Health Technology R&D Project through the Korea Health Industry Development Institute

Study record dates

Study Major Dates

• Study Start (Actual): September 25, 2020
• Primary Completion (Actual): November 6, 2020
• Study Completion (Actual): January 13, 2024

Study Registration Dates

• First Submitted: October 15, 2024
• First Submitted That Met QC Criteria: October 16, 2024
• First Posted (Actual): October 18, 2024

Study Record Updates

• Last Update Posted (Actual): October 18, 2024
• Last Update Submitted That Met QC Criteria: October 16, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: older adults; cognitive training; physical exercise
• Other Study ID Numbers: 2020-09-005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No