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

NCT06891573 | Recruiting DMC

• 1 other identifier: 2024-07-020
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Frailty

Keywords

frailty; intervention; multidomain; digital

Outcome Measures

Primary Outcomes (3)

• retention rate

  retention rate ≥ 70%

  From enrollment to the end of intervention at 16 weeks

• Adherence to the protocol

  Adherence to the protocol ≥ 70%

  From enrollment to the end of intervention at 16 weeks

• recruitment rate

  recruitment rate ≥ 50%.

  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

  From baseline to the end of intervention at 16 weeks

• Change from Baseline in Modified Fried frailty phenotype score at 16 weeks

  From baseline to the end of intervention at 16 weeks

• Change from Baseline in Lubben Social Network Scale at 16 weeks

  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

  From baseline to the end of intervention at 16 weeks

• Change from Baseline in Korean Mini-Mental State Examination-2 at 16 weeks

  From enrollment to the end of intervention at 16 weeks

Study Arms (2)

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.

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'.

Interventions

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.

Intervention group

Eligibility Criteria

• Age: 60 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seong Hye Choi, MD: lead

Study Sites (3)

Inha University Hospital

Incheon, 22332, South Korea

RECRUITING

Ewha Womans University Seoul hospital

Seoul, South Korea

NOT YET RECRUITING

Ajou University Hospital

Suwon, South Korea

NOT YET RECRUITING

Related Publications (1)

• 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.

  PMID: 41509872 DERIVED

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Seong Hye Choi, MD, PhD

  Inha University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Seong Hye Choi, MD, PhD

CONTACT

82 10-3120-2947; sseonghye@inha.ac.kr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 25, 2025
• First Posted: March 24, 2025
• Study Start: February 26, 2025
• Primary Completion: December 20, 2025
• Study Completion: January 15, 2026
• Last Updated: November 20, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: The data will become in 2027 and become available for 5 years.
• Access Criteria: The access criteria is an approval of steering committee.

Locations

KR (3)