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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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.

Первичные конечные точки

• retention rate [Срок оценки: From enrollment to the end of intervention at 16 weeks]
• Adherence to the protocol [Срок оценки: From enrollment to the end of intervention at 16 weeks]
• recruitment rate [Срок оценки: From enrollment to the end of intervention at 16 weeks]

Вторичные конечные точки (12)

• Change from Baseline in Korean Frailty Index for Primary Care at 16 weeks [Срок оценки: From baseline to the end of intervention at 16 weeks]
• Change from Baseline in Modified Fried frailty phenotype score at 16 weeks [Срок оценки: From baseline to the end of intervention at 16 weeks]
• Change from Baseline in Lubben Social Network Scale at 16 weeks [Срок оценки: 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 [Срок оценки: From baseline to the end of intervention at 16 weeks]
• Change from Baseline in Korean Mini-Mental State Examination-2 at 16 weeks [Срок оценки: From enrollment to the end of intervention at 16 weeks]
• Change from Baseline in Clinical Dementia Rating scale-Sum of Boxes at 16 weeks [Срок оценки: From baseline to the end of intervention at 16 weeks]
• Change from Baseline in Korean Instrumental Activities of Daily Living at 16 weeks [Срок оценки: From baseline to the end of intervention at 16 weeks]
• Change from Baseline in Modified Barthel Index: at 16 weeks [Срок оценки: From baseline to the end of intervention at 16 weeks]
• Change from Baseline in Center for Epidemiological Studies-Depression Scale at 16 weeks [Срок оценки: From baseline to the end of intervention at 16 weeks]
• Change from Baseline in Quality of life-Alzheimer's disease at 16 weeks [Срок оценки: From baseline to the end of intervention at 16 weeks]
• Change from Baseline in gait speed at 16 weeks [Срок оценки: From baseline to the end of intervention at 16 weeks]
• Change from Baseline in Short Physical Performance Battery at 16 weeks [Срок оценки: From baseline to the end of intervention at 16 weeks]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

South Korea · 3 центра

• Inha University Hospital — Incheon
• Ewha Womans University Seoul hospital — Seoul
• Ajou University Hospital — Suwon

Публикации

• 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

Идентификаторы

NCT: NCT06891573 · 2024-07-020

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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