NCT06891573招募中不适用
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
Seong Hye Choi, MD4 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年2月26日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- Adherence to the protocol
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Major psychiatric illness such as major depressive disorders
- •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
结局指标
主要结局
Adherence to the protocol
时间窗: From enrollment to the end of intervention at 16 weeks
Adherence to the protocol ≥ 70%
recruitment rate
时间窗: From enrollment to the end of intervention at 16 weeks
recruitment rate ≥ 50%.
retention rate
时间窗: From enrollment to the end of intervention at 16 weeks
retention rate ≥ 70%
Adherence to the protocol
时间窗: From enrollment to the end of intervention at 16 weeks
Adherence to the protocol ≥ 70%
recruitment rate
时间窗: From enrollment to the end of intervention at 16 weeks
recruitment rate ≥ 50%.
次要结局
- Change from Baseline in Korean Mini-Mental State Examination-2 at 16 weeks(From enrollment to the end of intervention at 16 weeks)
- Change from Baseline in Clinical Dementia Rating scale-Sum of Boxes at 16 weeks(From baseline to the end of intervention at 16 weeks)
- Change from Baseline in Korean Instrumental Activities of Daily Living at 16 weeks(From baseline to the end of intervention at 16 weeks)
- Change from baseline in MIND diet checklist at 16 weeks(From baseline to the end of intervention at 16 weeks)
- Change from baseline in International Physical Activity Questionnaire-Short Form at 16 weeks(From baseline to the end of intervention at 16 weeks)
- Change from baseline in LDL-C at 16 weeks(From baseline to the end of intervention at 16 weeks)
- Change from baseline in HDL-C at 16 weeks(From baseline to the end of intervention at 16 weeks)
- 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)
- Change from Baseline in Clinical Dementia Rating scale-Sum of Boxes at 16 weeks(From baseline to the end of intervention at 16 weeks)
- Change from Baseline in Korean Instrumental Activities of Daily Living at 16 weeks(From baseline to the end of intervention at 16 weeks)
- Change from Baseline in Modified Barthel Index: at 16 weeks(From baseline to the end of intervention at 16 weeks)
- Change from Baseline in Center for Epidemiological Studies-Depression Scale at 16 weeks(From baseline to the end of intervention at 16 weeks)
- Change from Baseline in Quality of life-Alzheimer's disease at 16 weeks(From baseline to the end of intervention at 16 weeks)
- Change from Baseline in gait speed at 16 weeks(From baseline to the end of intervention at 16 weeks)
- Change from Baseline in Short Physical Performance Battery at 16 weeks(From baseline to the end of intervention at 16 weeks)
- Change from Baseline inTimed Up and Go test at 16 weeks(From baseline to the end of intervention at 16 weeks)
- Change from Baseline in 30 s sit-to-stand at 16 weeks(From baseline to the end of intervention at 16 weeks)
- Change from Baseline in 2 min stepping test at 16 weeks(From baseline to the end of intervention at 16 weeks)
- Change from Baseline in Mini Nutritional Assessment at 16 weeks(From baseline to the end of intervention at 16 weeks)
- Change from Baseline in Nutritional Quotient for Elderly at 16 weeks(From baseline to the end of intervention at 16 weeks)
- Change from Baseline in skeletal muscle mass at 16 weeks(From baseline to the end of intervention at 16 weeks)
- Number of Participants with Treatment-Related Adverse Events(From enrollment to the end of intervention at 16 weeks)
- Change from baseline in MIND diet checklist at 16 weeks(From baseline to the end of intervention at 16 weeks)
- Change from baseline in International Physical Activity Questionnaire-Short Form at 16 weeks(From baseline to the end of intervention at 16 weeks)
- Change from baseline in LDL-C at 16 weeks(From baseline to the end of intervention at 16 weeks)
- Change from baseline in HDL-C at 16 weeks(From baseline to the end of intervention at 16 weeks)
- Change from baseline in HbA1c at 16 weeks(From baseline to the end of intervention at 16 weeks)
- Change from baseline in eGFR at 16 weeks(From baseline to the end of intervention at 16 weeks)
- Change from baseline in blood pressure at 16 weeks(From baseline to the end of intervention at 16 weeks)
- Change from baseline in body weight at 16 weeks(From baseline to the end of intervention at 16 weeks)
- Change from baseline in waist circumference at 16 weeks(From baseline to the end of intervention at 16 weeks)
- Occurrence of aging-related diseases(From baseline to the end of intervention at 16 weeks)
研究者
Seong Hye Choi, MD
Professor
Inha University Hospital
研究点 (4)
Loading locations...
相似试验
已完成
不适用
A Pilot- and Feasibility Trial of the EHealth Tool My COPD for People with COPDChronic Obstructive Pulmonary DiseaseNCT05086341Umeå University22
招募中
不适用
Eye Movement Desensitisation and Reprocessing (EMDR) to Improve Mental Health Following Intensive Care AdmissionPost Traumatic Stress DisorderCritical IllnessEye Movement Desensitisation and ReprocessingDepression, AnxietyNCT05591625University Hospital Southampton NHS Foundation Trust160
已完成
不适用
A Study Protocol Comparing a Home Rehabilitation Program Versus e-Health Program in Low Back PainChronic Low-back PainNCT04283370Universidad de Almeria80
已完成
不适用
Check and Support -Enhancing the Treatment of Hypertension in Outpatient Care, a Multicenter StudyBlood PressurePatient CompliancePatient AdherenceMedication AdherenceHypertensionNCT02377960Kuopio University Hospital119
暂停
不适用
Early Internal Fixation Versus NonOperative Care With Early Rehabilitation for LC1 Fragility Fractures of the PelvisNCT06496867University of Southern California48