ElderlyNCT06648343
Intensive Home-based Complex Training in Elderly
A study testing Intensive cognitive and physical training in people with Elderly, run by Bundang CHA Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Elderly
- What is being tested?
- Intensive cognitive and physical training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteSouth Korea
- Study dates
- 25 Sep 2020to 13 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
CHA Bundang Medical Center
Seongnam-si, Gyeonggi-do, 13609
About this study
Official title: 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.
Read the 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.
- Conditions
- Elderly
- Being tested
- Intensive cognitive and physical training
- Keywords
- cognitive training, physical exercise, older adults
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive cognitive and physical trainingOther
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
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Intensive cognitive and physical training Receives: Other: Intensive cognitive and physical training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2024
- Study start25 Sep 2020
- Primary completion6 Nov 2020
- Study completion13 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ElderlyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bundang CHA Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Science and ICT, Republic of Korea, The Korea Health Technology R&D Project through the Korea Health Industry Development Institute
- Responsible party
- Principal investigator, MinYoung Kim, MD, PhD, Bundang CHA Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06648343
- Sponsor's protocol ID
- 2020-09-005
- Status last verified
- Oct 2024
- First submitted
- 15 Oct 2024
- Last updated
- 18 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Shin S, Lim I, Baik H, Park E, Hong JM, Kim JM, Kim M. Feasibility of a short-term intensive home-based cognitive and physical training program for older adults: a single-arm pilot study. BMC Geriatr. 2026 May 16;26(1):929. doi: 10.1186/s12877-026-07655-9.
PubMed 42143241
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cognitive and Physical Function Training in the Elderly
- ClinicalTrials.gov ID
- NCT06648343
- Acronym / sponsor ID
- 2020-09-005
- Conditions
- Elderly
- Keywords
- cognitive training, physical exercise, older adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Bundang CHA HospitalUniversity, hospital or other
- Collaborators
- Ministry of Science and ICT, Republic of Korea, The Korea Health Technology R&D Project through the Korea Health Industry Development Institute
- Study start
- 25 Sep 2020 (actual)
- Primary completion
- 6 Nov 2020 (actual)
- Study completion
- 13 Jan 2024 (actual)
- First posted
- 18 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Intensive cognitive and physical trainingIntensive cognitive and physical training |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intensive cognitive and physical trainingThe 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 | Other | Intervention |
Primary outcome
K-MMSE (Korean Mini-Mental Status Examination)
Time frame: 4 weeks
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.
3 secondary outcomes
RBANS (Repeatable Battery for the Assessment of Neuropsychological Status)
Time frame: 4 weeks
K-MBI (Korean Version of the Modified Barthel Index)
Time frame: 4 weeks
BBS (Berg Balance Scale)
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2024.
- Derived from this study: PubMed 42143241Shin S, Lim I, Baik H, Park E, Hong JM, Kim JM, Kim M. Feasibility of a short-term intensive home-based cognitive and physical training program for older adults: a single-arm pilot study. BMC Geriatr. 2026 May 16;26(1):929. doi: 10.1186/s12877-026-07655-9.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensive cognitive and physical training in people with Elderly, run by Bundang CHA Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
K-MMSE (Korean Mini-Mental Status Examination) (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06648343, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2024; AzTrials last refreshed its copy on 30 Oct 2026.