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

NCT ID: NCT06891573

Last Updated: 2025-11-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-26
• Study Completion Date: 2026-01-15

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Lifestyle Management

Intervention Type: 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.

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'.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seong Hye Choi, MD

OTHER

Sponsor Role: lead

Responsible Party

Seong Hye Choi, MD

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Seong Hye Choi, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Inha University Hospital

Locations

Inha University Hospital

Incheon, , South Korea

Site Status: RECRUITING

Ewha Womans University Seoul hospital

Seoul, , South Korea

Site Status: NOT_YET_RECRUITING

Ajou University Hospital

Suwon, , South Korea

Site Status: NOT_YET_RECRUITING

Countries

South Korea

Central Contacts

Seong Hye Choi, MD, PhD

Role: CONTACT

sseonghye@inha.ac.kr

82 10-3120-2947

Facility Contacts

Seong Hye Choi, MD PhD

Role: primary

seonghye@inha.ac.kr

82-32-8903659

Jee Hyang Jeong, MD PhD

Role: primary

jjeong@ewha.ac.kr

82-10-9085-1927

So Young Moon, MD PhD

Role: primary

symoon.bv@gmail.com

Other Identifiers

2024-07-020

Identifier Type: -

Identifier Source: org_study_id