South Korean Study to Prevent Frailty and Aging-related Diseases Through Lifestyle Intervention (SUPERAGING)

November 17, 2025 updated by: Seong Hye Choi, MD

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • South Korea
      • Incheon, South Korea, 22332
        • Recruiting
        • Inha University Hospital
        • Principal Investigator:
          • Seong Hye Choi, MD, PhD
        • Contact:
      • Seoul, South Korea
        • Not yet recruiting
        • Ewha Womans University Seoul Hospital
        • Contact:
        • Principal Investigator:
          • Jee Hyang Jeong, MD, PhD
      • Suwon, South Korea
        • Not yet recruiting
        • Ajou University Hospital
        • Contact:
        • Principal Investigator:
          • So Young Moon, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
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.
Behavioral: Lifestyle Management
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.
No Intervention: Control
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
retention rate
Time Frame: From enrollment to the end of intervention at 16 weeks
retention rate ≥ 70%
From enrollment to the end of intervention at 16 weeks
Adherence to the protocol
Time Frame: From enrollment to the end of intervention at 16 weeks
Adherence to the protocol ≥ 70%
From enrollment to the end of intervention at 16 weeks
recruitment rate
Time Frame: From enrollment to the end of intervention at 16 weeks
recruitment rate ≥ 50%.
From enrollment to the end of intervention at 16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
The score ranges from 0 to 1. A lower score indicates better performance.
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
The score ranges from 0 to 5. A lower score indicates better performance.
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
The score ranges from 0 to 50. A higher score indicates better performance.
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
The score ranges from 0 to 90. A lower score indicates better performance.
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
The score ranges from 0 to 30. A higher score indicates better performance.
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
The score ranges from 0 to 18. A lower score indicates better performance.
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
The score ranges from 0 to 3. A lower score indicates better performance.
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
The score ranges from 0 to 100. A higher score indicates better performance.
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
The score ranges from 0 to 60. A lower score indicates better performance.
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
The score ranges from 0 to 52. A higher score indicates better performance.
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
A lower score indicates better performance.
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
The score ranges from 0 to 12. A higher score indicates better performance.
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
A lower score indicates better performance.
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
A higher score indicates better performance.
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
A higher score indicates better performance.
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
The score ranges from 0 to 14. A higher score indicates better performance.
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
The score ranges from 0 to 100. A higher score indicates better performance.
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
A higher score indicates better performance.
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
A lower score indicates better performance.
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
The score ranges from 0 to 15. A higher score indicates better performance.
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
The score ranges from 0 to 20,000. A higher score indicates better performance.
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
The score ranges from 0 to 300. A lower score indicates better performance.
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
The score ranges from 0 to 200. A higher score indicates better performance.
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
The score ranges from 0 to 30. A lower score indicates better performance.
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
The score ranges from 0 to 200. A higher score indicates better performance.
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
The score ranges from 0 to 250. A lower score indicates better performance.
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
The score ranges from 0 to 200. A higher score indicates better performance in frailty.
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
The score ranges from 0 to 200. A higher score indicates better performance in frailty.
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
The score ranges from 0 to 10. A lower score indicates better performance.
From baseline to the end of intervention at 16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seong Hye Choi, MD

Investigators

  • Principal Investigator: Seong Hye Choi, MD, PhD, Inha University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 26, 2025

Primary Completion (Estimated)

December 20, 2025

Study Completion (Estimated)

January 15, 2026

Study Registration Dates

First Submitted

February 25, 2025

First Submitted That Met QC Criteria

March 20, 2025

First Posted (Actual)

March 24, 2025

Study Record Updates

Last Update Posted (Actual)

November 20, 2025

Last Update Submitted That Met QC Criteria

November 17, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-07-020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data will be shared with the Global Alzheimer's Association Interactive Network.

IPD Sharing Time Frame

The data will become in 2027 and become available for 5 years.

IPD Sharing Access Criteria

The access criteria is an approval of steering committee.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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