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

Last updated: March 20, 2025
Sponsor: Seong Hye Choi, MD
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Lifestyle Management

Clinical Study ID

NCT06891573
2024-07-020
  • Ages 60-90
  • All Genders

Study 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 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.

Eligibility Criteria

Inclusion

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 aparticipant use the mobile app

  • Having a reliable informant who could provide investigators with the requestedinformation.

  • written informed consent

Exclusion

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, activegastric 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 Design

Total Participants: 40
Treatment Group(s): 1
Primary Treatment: Lifestyle Management
Phase:
Study Start date:
February 26, 2025
Estimated Completion Date:
January 15, 2026

Study 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.

Connect with a study center

  • Inha University Hospital

    Incheon, 22332
    Korea, Republic of

    Active - Recruiting

  • Ewha Womans University Seoul hospital

    Seoul,
    Korea, Republic of

    Site Not Available

  • Ajou University Hospital

    Suwon,
    Korea, Republic of

    Site Not Available

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