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

Seong Hye Choi, MD

Status: Enrolling

Conditions: Frailty

Treatments: Behavioral: Lifestyle Management

Study type: Interventional

Funder types: Other

Identifiers

NCT06891573

2024-07-020

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 60 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Intervention group

Experimental group

Description:

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.

Treatment:

Behavioral: Lifestyle Management

Control

No Intervention group

Description:

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'.