Intensive Home-based Complex Training in Elderly

NCT ID: NCT06648343

Last Updated: 2024-10-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-25

Study Completion Date

2024-01-13

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Elderly

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention

Intensive cognitive and physical training

Group Type EXPERIMENTAL

Intensive cognitive and physical training

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ministry of Science and ICT, Republic of Korea

OTHER_GOV

Sponsor Role collaborator

The Korea Health Technology R&D Project through the Korea Health Industry Development Institute

UNKNOWN

Sponsor Role collaborator

Bundang CHA Hospital

OTHER

Sponsor Role lead

Responsible Party

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MinYoung Kim, MD, PhD

Prof

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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CHA Bundang Medical Center

Seongnam-si, Gyeonggi-do, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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2020-09-005

Identifier Type: -

Identifier Source: org_study_id

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