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NCT Number: NCT06891573

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

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.

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Key information

Conditions

Frailty Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

60 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Inha University Hospital, Incheon, South Korea

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lifestyle Management

Behavioral

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.

Primary outcomes

  1. retention rate

    Time frame: From enrollment to the end of intervention at 16 weeks

    retention rate ≥ 70%

  2. Adherence to the protocol

    Time frame: From enrollment to the end of intervention at 16 weeks

    Adherence to the protocol ≥ 70%

  3. recruitment rate

    Time frame: From enrollment to the end of intervention at 16 weeks

    recruitment rate ≥ 50%.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. 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.

  20. 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.

  21. 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.

  22. 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.

  23. 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.

  24. 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.

  25. 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.

  26. 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.

  27. 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.

  28. 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.

  29. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Seong Hye Choi, MD, PhD

CONTACT

[email protected]

82 10-3120-2947

Sponsors and collaborators

Lead sponsor

Seong Hye Choi, MD

Other

Registry information

Official study 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

Acronym: SUPERAGING

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Mar 24, 2025
Registry last updated
Nov 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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