FrailtySUPERAGINGNCT06891573
South Korean Study to Prevent Frailty and Aging-related Diseases Through Lifestyle Intervention
A study testing Lifestyle Management in people with Frailty, run by Seong Hye Choi, MD at 3 sites in South Korea.
Trial summary
The goal of this feasibility randomized controlled trial is to investigate the applicability of software that aims to improve symptoms of frailty by implementing customized interventions such as physical exercise and cognitive training implemented through a mobile app for 16 weeks for patients diagnosed with frailty… Read more about this study
- Who is it for?
- Ages 60 to 90 years
- Conditions the study is for
- Frailty
- What is being tested?
- Lifestyle Management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 3 sitesSouth Korea
- Study dates
- 26 Feb 2025to 15 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 60-90 years of age
- Residing in the community
- Total score of Modified Fried frailty phenotype score ≥ 1 point
- Korean Mini-Mental State Examination-2 z-score ≥ -1.5
- Can read and write
- Being able to use the a mobile app through education or having someone help a participant use the mobile app
- Having a reliable informant who could provide investigators with the requested information.
- written informed consent
Who cannot join
- Major psychiatric illness such as major depressive disorders
- Dementia
- Other neurodegenerative disease (e.g., Parkinson's disease)
- Malignancy within five years
- Cardiac stent or revascularization within one year
- Serious or unstable symptomatic cardiovascular disease
Show all 12Show fewer
- Other serious or unstable medical disease such as acute or severe asthma, active gastric ulcer, severe liver disease, or severe renal disease
- Severe loss of vision, hearing, or communicative disability
- Significant laboratory abnormality that may result in cognitive impairment
- Any conditions preventing cooperation as judged by the study physician
- Unable to participate in exercise program safely
- Coincident participation in any other intervention trial
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea3 sites, 3 recruiting
- Recruiting
Inha University Hospital
Incheon, 22332
Seong Hye Choi, MD PhD, 82-32-8903659, seonghye@inha.ac.kr
Seong Hye Choi, MD, PhD
- Not yet recruiting
Ewha Womans University Seoul hospital
Seoul
Jee Hyang Jeong, MD PhD, 82-10-9085-1927, jjeong@ewha.ac.kr
Jee Hyang Jeong, MD, PhD
- Not yet recruiting
Ajou University Hospital
Suwon
So Young Moon, MD PhD, symoon.bv@gmail.com
So Young Moon, MD, PhD
About this study
Official title: A Multicenter, Feasibility Randomized Controlled Study to Evaluate the Applicability and Safety of the Software 'SUPERAGING' for Cognitive Therapy and Musculoskeletal Analysis in Frail or Prefrail Patients
The goal of this feasibility randomized controlled trial is to investigate the applicability of software that aims to improve symptoms of frailty by implementing customized interventions such as physical exercise and cognitive training implemented through a mobile app for 16 weeks for patients diagnosed with frailty or prefrailty. The primary outcomes are adherence, retention rates, and recruitment rates. Participants will participate in customized interventions including physical exercise, cognitive training, nutritional guidance, and management of disease related to frailty for 16 weeks.
Read the detailed description
The physical exercise program will comprise aerobic exercise, balance-improving exercises, flexibility-enhancing activities, and strength-building exercises targeting major muscle groups through a mobile app . Customized cognitive training, performed using a mobile app, targets the cognitive domains of prospective memory and executive function. Nutritional intervention will be performed to treat frailty symptoms and disease related to frailty through a mobile app. Education and management of disease related to frailty will be done through a mobile app.
- Conditions
- Frailty
- Being tested
- Lifestyle Management
- Keywords
- frailty, intervention, multidomain, digital
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle ManagementBehavioural
For 16 weeks, participants will receive exercise, cognitive training, nutrition education, and disease education through a smartphone app, and the content and intensity of the intervention will be adjusted every four weeks through an assessment of frailty symptoms through the app.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Participants will receive interventions including exercise, cognitive training, nutrition education, and management of diseases related to frailty via the app for one hour per day, five days a week for 16 weeks. Receives: Behavioral: Lifestyle Management |
| Control | No intervention | Participants in the control group will receive standard treatment related to frailty during the study period and be provided with guidelines on 'Lifestyle habits for treating frailty or prefrailty'. |
What is being measured
The primary outcome is the main question the study is designed to answer.
retention rate
retention rate ≥ 70%
Measured: From enrollment to the end of intervention at 16 weeks
Adherence to the protocol
Adherence to the protocol ≥ 70%
Measured: From enrollment to the end of intervention at 16 weeks
recruitment rate
recruitment rate ≥ 50%.
Measured: From enrollment to the end of intervention at 16 weeks
Secondary outcomes (29)
Change from Baseline in Korean Frailty Index for Primary Care at 16 weeks
The score ranges from 0 to 1. A lower score indicates better performance.
Measured: From baseline to the end of intervention at 16 weeks
Change from Baseline in Modified Fried frailty phenotype score at 16 weeks
The score ranges from 0 to 5. A lower score indicates better performance.
Measured: From baseline to the end of intervention at 16 weeks
Change from Baseline in Lubben Social Network Scale at 16 weeks
The score ranges from 0 to 50. A higher score indicates better performance.
Measured: From baseline to the end of intervention at 16 weeks
Change from Baseline in 14-item cognitive subscale of the Alzheimer's Disease Assessment Scale at 16 weeks
The score ranges from 0 to 90. A lower score indicates better performance.
Measured: From baseline to the end of intervention at 16 weeks
Change from Baseline in Korean Mini-Mental State Examination-2 at 16 weeks
The score ranges from 0 to 30. A higher score indicates better performance.
Measured: From enrollment to the end of intervention at 16 weeks
Change from Baseline in Clinical Dementia Rating scale-Sum of Boxes at 16 weeks
The score ranges from 0 to 18. A lower score indicates better performance.
Measured: From baseline to the end of intervention at 16 weeks
Change from Baseline in Korean Instrumental Activities of Daily Living at 16 weeks
The score ranges from 0 to 3. A lower score indicates better performance.
Measured: From baseline to the end of intervention at 16 weeks
Change from Baseline in Modified Barthel Index: at 16 weeks
The score ranges from 0 to 100. A higher score indicates better performance.
Measured: From baseline to the end of intervention at 16 weeks
Change from Baseline in Center for Epidemiological Studies-Depression Scale at 16 weeks
The score ranges from 0 to 60. A lower score indicates better performance.
Measured: From baseline to the end of intervention at 16 weeks
Change from Baseline in Quality of life-Alzheimer's disease at 16 weeks
The score ranges from 0 to 52. A higher score indicates better performance.
Measured: From baseline to the end of intervention at 16 weeks
Change from Baseline in gait speed at 16 weeks
A lower score indicates better performance.
Measured: From baseline to the end of intervention at 16 weeks
Change from Baseline in Short Physical Performance Battery at 16 weeks
The score ranges from 0 to 12. A higher score indicates better performance.
Measured: From baseline to the end of intervention at 16 weeks
Change from Baseline inTimed Up and Go test at 16 weeks
A lower score indicates better performance.
Measured: From baseline to the end of intervention at 16 weeks
Change from Baseline in 30 s sit-to-stand at 16 weeks
A higher score indicates better performance.
Measured: From baseline to the end of intervention at 16 weeks
Change from Baseline in 2 min stepping test at 16 weeks
A higher score indicates better performance.
Measured: From baseline to the end of intervention at 16 weeks
Change from Baseline in Mini Nutritional Assessment at 16 weeks
The score ranges from 0 to 14. A higher score indicates better performance.
Measured: From baseline to the end of intervention at 16 weeks
Change from Baseline in Nutritional Quotient for Elderly at 16 weeks
The score ranges from 0 to 100. A higher score indicates better performance.
Measured: From baseline to the end of intervention at 16 weeks
Change from Baseline in skeletal muscle mass at 16 weeks
A higher score indicates better performance.
Measured: From baseline to the end of intervention at 16 weeks
Number of Participants with Treatment-Related Adverse Events
A lower score indicates better performance.
Measured: From enrollment to the end of intervention at 16 weeks
Change from baseline in MIND diet checklist at 16 weeks
The score ranges from 0 to 15. A higher score indicates better performance.
Measured: From baseline to the end of intervention at 16 weeks
Change from baseline in International Physical Activity Questionnaire-Short Form at 16 weeks
The score ranges from 0 to 20,000. A higher score indicates better performance.
Measured: From baseline to the end of intervention at 16 weeks
Change from baseline in LDL-C at 16 weeks
The score ranges from 0 to 300. A lower score indicates better performance.
Measured: From baseline to the end of intervention at 16 weeks
Change from baseline in HDL-C at 16 weeks
The score ranges from 0 to 200. A higher score indicates better performance.
Measured: From baseline to the end of intervention at 16 weeks
Change from baseline in HbA1c at 16 weeks
The score ranges from 0 to 30. A lower score indicates better performance.
Measured: From baseline to the end of intervention at 16 weeks
Change from baseline in eGFR at 16 weeks
The score ranges from 0 to 200. A higher score indicates better performance.
Measured: From baseline to the end of intervention at 16 weeks
Change from baseline in blood pressure at 16 weeks
The score ranges from 0 to 250. A lower score indicates better performance.
Measured: From baseline to the end of intervention at 16 weeks
Change from baseline in body weight at 16 weeks
The score ranges from 0 to 200. A higher score indicates better performance in frailty.
Measured: From baseline to the end of intervention at 16 weeks
Change from baseline in waist circumference at 16 weeks
The score ranges from 0 to 200. A higher score indicates better performance in frailty.
Measured: From baseline to the end of intervention at 16 weeks
Occurrence of aging-related diseases
The score ranges from 0 to 10. A lower score indicates better performance.
Measured: From baseline to the end of intervention at 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2025
- Study start26 Feb 2025
- Primary completion20 Dec 2025 (estimated)
- Study completion15 Jan 2026 (estimated)
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 FrailtyStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seong Hye Choi, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Seong Hye Choi, MD, Inha University Hospital
- Investigators
- Seong Hye Choi, MD, PhD, Principal investigator, Inha University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06891573
- Sponsor's protocol ID
- 2024-07-020
- Acronym
- SUPERAGING
- Status last verified
- Nov 2025
- First submitted
- 25 Feb 2025
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data will be shared with the Global Alzheimer's Association Interactive Network.
Publications
Jung S, Kang HJ, Moon SY, Choi M, Jung J, Kim HR, Jung S, Jeong JH, Choi SH, Park YK. South Korean study to prevent the progression of frailty and aging-related diseases using a digital multidomain intervention (SUPERAGING): Protocol of a feasibility pilot study. Digit Health. 2026 Jan 6;12:20552076251410995. doi: 10.1177/20552076251410995. eCollection 2026 Jan-Dec.
PubMed 41509872
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Feasibility Randomized Controlled Study to Evaluate the Applicability and Safety of the Software 'SUPERAGING' for Cognitive Therapy and Musculoskeletal Analysis in Frail or Prefrail Patients
- ClinicalTrials.gov ID
- NCT06891573
- Acronym / sponsor ID
- SUPERAGING / 2024-07-020
- Conditions
- Frailty
- Keywords
- frailty, intervention, multidomain, digital
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Seong Hye Choi, MDUniversity, hospital or other
- Study start
- 26 Feb 2025 (actual)
- Primary completion
- 20 Dec 2025 (estimated)
- Study completion
- 15 Jan 2026 (estimated)
- First posted
- 24 Mar 2025 (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.
The goal of this feasibility randomized controlled trial is to investigate the applicability of software that aims to improve symptoms of frailty by implementing customized interventions such as physical exercise and cognitive training implemented through a mobile app for 16 weeks for patients diagnosed with frailty or prefrailty. The primary outcomes are adherence, retention rates, and recruitment rates. Participants will participate in customized interventions including physical exercise, cognitive training, nutritional guidance, and management of disease related to frailty for 16 weeks.
Detailed description
The physical exercise program will comprise aerobic exercise, balance-improving exercises, flexibility-enhancing activities, and strength-building exercises targeting major muscle groups through a mobile app . Customized cognitive training, performed using a mobile app, targets the cognitive domains of prospective memory and executive function. Nutritional intervention will be performed to treat frailty symptoms and disease related to frailty through a mobile app. Education and management of disease related to frailty will be done through a mobile app.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Lifestyle ManagementParticipants will receive interventions including exercise, cognitive training, nutrition education, and management of diseases related to frailty via the app for one hour per day, five days a week for 16 weeks. |
| Control | No intervention | –Participants in the control group will receive standard treatment related to frailty during the study period and be provided with guidelines on 'Lifestyle habits for treating frailty or prefrailty'. |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 60-90 years of age
- Residing in the community
- Total score of Modified Fried frailty phenotype score ≥ 1 point
- Korean Mini-Mental State Examination-2 z-score ≥ -1.5
- Can read and write
Key exclusion criteria (12 listed)
- Major psychiatric illness such as major depressive disorders
- Dementia
- Other neurodegenerative disease (e.g., Parkinson's disease)
- Malignancy within five years
- Cardiac stent or revascularization within one year
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 |
|---|---|---|
| Lifestyle ManagementFor 16 weeks, participants will receive exercise, cognitive training, nutrition education, and disease education through a smartphone app, and the content and intensity of the intervention will be adjusted every four weeks through an assessment of frailty symptoms through the app. | Behavioural | Intervention group |
Primary outcome
retention rate
Time frame: From enrollment to the end of intervention at 16 weeks
retention rate ≥ 70%
Adherence to the protocol
Time frame: From enrollment to the end of intervention at 16 weeks
Adherence to the protocol ≥ 70%
recruitment rate
Time frame: From enrollment to the end of intervention at 16 weeks
recruitment rate ≥ 50%.
29 secondary outcomes
Change from Baseline in Korean Frailty Index for Primary Care at 16 weeks
Time frame: From baseline to the end of intervention at 16 weeks
Change from Baseline in Modified Fried frailty phenotype score at 16 weeks
Time frame: From baseline to the end of intervention at 16 weeks
Change from Baseline in Lubben Social Network Scale at 16 weeks
Time frame: From baseline to the end of intervention at 16 weeks
Change from Baseline in 14-item cognitive subscale of the Alzheimer's Disease Assessment Scale at 16 weeks
Time frame: From baseline to the end of intervention at 16 weeks
Change from Baseline in Korean Mini-Mental State Examination-2 at 16 weeks
Time frame: From enrollment to the end of intervention at 16 weeks
Change from Baseline in Clinical Dementia Rating scale-Sum of Boxes at 16 weeks
Time frame: From baseline to the end of intervention at 16 weeks
Change from Baseline in Korean Instrumental Activities of Daily Living at 16 weeks
Time frame: From baseline to the end of intervention at 16 weeks
Change from Baseline in Modified Barthel Index: at 16 weeks
Time frame: From baseline to the end of intervention at 16 weeks
Change from Baseline in Center for Epidemiological Studies-Depression Scale at 16 weeks
Time frame: From baseline to the end of intervention at 16 weeks
Change from Baseline in Quality of life-Alzheimer's disease at 16 weeks
Time frame: From baseline to the end of intervention at 16 weeks
Change from Baseline in gait speed at 16 weeks
Time frame: From baseline to the end of intervention at 16 weeks
Change from Baseline in Short Physical Performance Battery at 16 weeks
Time frame: From baseline to the end of intervention at 16 weeks
Change from Baseline inTimed Up and Go test at 16 weeks
Time frame: From baseline to the end of intervention at 16 weeks
Change from Baseline in 30 s sit-to-stand at 16 weeks
Time frame: From baseline to the end of intervention at 16 weeks
Change from Baseline in 2 min stepping test at 16 weeks
Time frame: From baseline to the end of intervention at 16 weeks
Change from Baseline in Mini Nutritional Assessment at 16 weeks
Time frame: From baseline to the end of intervention at 16 weeks
Change from Baseline in Nutritional Quotient for Elderly at 16 weeks
Time frame: From baseline to the end of intervention at 16 weeks
Change from Baseline in skeletal muscle mass at 16 weeks
Time frame: From baseline to the end of intervention at 16 weeks
Number of Participants with Treatment-Related Adverse Events
Time frame: From enrollment to the end of intervention at 16 weeks
Change from baseline in MIND diet checklist at 16 weeks
Time frame: From baseline to the end of intervention at 16 weeks
Change from baseline in International Physical Activity Questionnaire-Short Form at 16 weeks
Time frame: From baseline to the end of intervention at 16 weeks
Change from baseline in LDL-C at 16 weeks
Time frame: From baseline to the end of intervention at 16 weeks
Change from baseline in HDL-C at 16 weeks
Time frame: From baseline to the end of intervention at 16 weeks
Change from baseline in HbA1c at 16 weeks
Time frame: From baseline to the end of intervention at 16 weeks
Change from baseline in eGFR at 16 weeks
Time frame: From baseline to the end of intervention at 16 weeks
Change from baseline in blood pressure at 16 weeks
Time frame: From baseline to the end of intervention at 16 weeks
Change from baseline in body weight at 16 weeks
Time frame: From baseline to the end of intervention at 16 weeks
Change from baseline in waist circumference at 16 weeks
Time frame: From baseline to the end of intervention at 16 weeks
Occurrence of aging-related diseases
Time frame: From baseline to the end of intervention at 16 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Derived from this study: PubMed 41509872Jung S, Kang HJ, Moon SY, Choi M, Jung J, Kim HR, Jung S, Jeong JH, Choi SH, Park YK. South Korean study to prevent the progression of frailty and aging-related diseases using a digital multidomain intervention (SUPERAGING): Protocol of a feasibility pilot study. Digit Health. 2026 Jan 6;12:20552076251410995. doi: 10.1177/20552076251410995. eCollection 2026 Jan-Dec.
- Individual participant dataSharing planned: Yes. Individual participant data will be shared with the Global Alzheimer's Association Interactive Network.
Related trials for Frailty
Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
Recruiting
Comparıson of the Effıcacy of Conventıonal Exercıse and Pılates ın Pre-fraıl and Fraıl Older Adults
Frailty Syndrome, Prefrail Elderly
Not yet recruiting
Adapting an Evidence-Based Physical Activity Intervention to Prevent Frailty and Functional Decline in Older Women Living With HIV
Mobility Impairment, Frailty
Recruiting
Assisted Ambulation to Improve Health Outcomes for Older Medical Inpatients
Mobility Limitation, Frailty
Not yet recruiting
Virtual Reality Multidomain Training for Older Adults With Cognitive Frailty
Cognitive Frailty
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.
Seong Hye Choi, MD, PhD principal investigator
Inha University Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle Management in people with Frailty, run by Seong Hye Choi, MD at 3 sites 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 8 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Seong Hye Choi, MD, PhD (82 10-3120-2947, sseonghye@inha.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
retention rate (time frame: From enrollment to the end of intervention at 16 weeks). The study lists 3 primary outcomes in all. 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 NCT06891573, 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 20 Nov 2025.