Clinical trial NCT06891573: South Korean Study to Prevent Frailty and Aging-related Diseases Through Lifestyle Intervention
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Frailty
Keywords: frailty
intervention
multidomain
digital
Lead sponsor: Inha University Hospital
Sponsor class: OTHER
First posted: 2025-03-24
Enrollment: 40
Sex: ALL
Minimum age (years): 60
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: retention rate
timeFrame: From enrollment to the end of intervention at 16 weeks
measure: Adherence to the protocol
timeFrame: From enrollment to the end of intervention at 16 weeks
measure: recruitment rate
timeFrame: From enrollment to the end of intervention at 16 weeks
Secondary outcomes:
measure: Change from Baseline in Korean Frailty Index for Primary Care at 16 weeks
timeFrame: From baseline to the end of intervention at 16 weeks
measure: Change from Baseline in Modified Fried frailty phenotype score at 16 weeks
timeFrame: From baseline to the end of intervention at 16 weeks
measure: Change from Baseline in Lubben Social Network Scale at 16 weeks
timeFrame: From baseline to the end of intervention at 16 weeks
measure: Change from Baseline in 14-item cognitive subscale of the Alzheimer's Disease Assessment Scale at 16 weeks
timeFrame: From baseline to the end of intervention at 16 weeks
measure: Change from Baseline in Korean Mini-Mental State Examination-2 at 16 weeks
timeFrame: From enrollment to the end of intervention at 16 weeks
measure: Change from Baseline in Clinical Dementia Rating scale-Sum of Boxes at 16 weeks
timeFrame: From baseline to the end of intervention at 16 weeks
measure: Change from Baseline in Korean Instrumental Activities of Daily Living at 16 weeks
timeFrame: From baseline to the end of intervention at 16 weeks
measure: Change from Baseline in Modified Barthel Index: at 16 weeks
timeFrame: From baseline to the end of intervention at 16 weeks
measure: Change from Baseline in Center for Epidemiological Studies-Depression Scale at 16 weeks
timeFrame: From baseline to the end of intervention at 16 weeks
measure: Change from Baseline in Quality of life-Alzheimer's disease at 16 weeks
timeFrame: From baseline to the end of intervention at 16 weeks
measure: Change from Baseline in gait speed at 16 weeks
timeFrame: From baseline to the end of intervention at 16 weeks
measure: Change from Baseline in Short Physical Performance Battery at 16 weeks
timeFrame: From baseline to the end of intervention at 16 weeks
measure: Change from Baseline inTimed Up and Go test at 16 weeks
timeFrame: From baseline to the end of intervention at 16 weeks
measure: Change from Baseline in 30 s sit-to-stand at 16 weeks
timeFrame: From baseline to the end of intervention at 16 weeks
measure: Change from Baseline in 2 min stepping test at 16 weeks
timeFrame: From baseline to the end of intervention at 16 weeks
measure: Change from Baseline in Mini Nutritional Assessment at 16 weeks
timeFrame: From baseline to the end of intervention at 16 weeks
measure: Change from Baseline in Nutritional Quotient for Elderly at 16 weeks
timeFrame: From baseline to the end of intervention at 16 weeks
measure: Change from Baseline in skeletal muscle mass at 16 weeks
timeFrame: From baseline to the end of intervention at 16 weeks
measure: Number of Participants with Treatment-Related Adverse Events
timeFrame: From enrollment to the end of intervention at 16 weeks
Other outcomes:
Locations:
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
city: Seoul
country: Korea, Republic of
facility: Ewha Womans University Seoul hospital
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
Study officials:
affiliation: Inha University Hospital
name: Seong Hye Choi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: