Clinical trial NCT06648343: Intensive Home-based Complex Training in Elderly
Official title: Effect of Cognitive and Physical Function Training in the Elderly
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Elderly
Keywords: cognitive training
physical exercise
older adults
Lead sponsor: Bundang CHA Hospital
Sponsor class: OTHER
Collaborators: name: Ministry of Science and ICT, Republic of Korea
name: The Korea Health Technology R&D Project through the Korea Health Industry Development Institute
First posted: 2024-10-18
Enrollment: 27
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: K-MMSE (Korean Mini-Mental Status Examination)
timeFrame: 4 weeks
Secondary outcomes:
measure: RBANS (Repeatable Battery for the Assessment of Neuropsychological Status)
timeFrame: 4 weeks
measure: K-MBI (Korean Version of the Modified Barthel Index)
timeFrame: 4 weeks
measure: BBS (Berg Balance Scale)
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: CHA Bundang Medical Center
state: Gyeonggi-do
Study officials:
References: