A Multicenter, Prospective, Randomized, Parallel-Group, Double-blinded, Confirmatory Clinical Trial to Evaluate the Safety and Efficacy of a Digital Therapeutic Device for Improving Muscle Strength in Patients With Sarcopenia
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 130
- 试验地点
- 6
- 主要终点
- Change in peak knee extension strength (Nm) from baseline to 12 weeks
研究概览
简要总结
This clinical trial aims to demonstrate that the use of a digital therapeutic device (exoDTx) in patients with sarcopenia is superior to self-exercise in terms of muscle strength improvement and safety.
详细描述
Background Sarcopenia is a condition characterized by progressive loss of skeletal muscle mass and strength, which is closely associated with functional decline, falls, and increased mortality.Conventional first-line treatment involves resistance training; however, in older adults, low adherence and practical challenges often limit its effectiveness.Recently, digital therapeutics (DTx) have emerged as promising tools by providing personalized exercise programs, automatic adjustment of intensity, and integrated recording and monitoring functions. These features are expected to overcome the limitations of selfdirected exercise.Therefore, this study seeks to validate the effectiveness and safety of DTx in improving muscle strength and physical function through a randomized controlled trial (RCT). Research Hypothesis In patients with sarcopenia, the group using digital therapeutics (DTx) will demonstrate superior outcomes in muscle strength improvement and safety compared to the self-exercise group.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals diagnosed with sarcopenia according to both the European Working Group on Sarcopenia in Older People (EWGSOP) criteria and the Asian Working Group for Sarcopenia 2019 (AWGS 2019) criteria
- •Individuals with reduced muscle strength, defined as at least one of the following:
- •Handgrip strength < 28 kg for men or < 18 kg for women
- •Five-times Sit-to-Stand Test time > 12 seconds without arm support
- •Individuals with reduced muscle mass, defined as at least one of the following:
- •Skeletal Muscle Mass Index (SMI) < 7.0 kg/m² for men or < 5.4 kg/m² for women measured by DXA
- •Skeletal Muscle Mass Index (SMI) < 7.0 kg/m² for men or < 5.7 kg/m² for women measured by BIA
- •Individuals able to independently perform sit-to-stand movements
- •Individuals with sufficient physical and cognitive capacity to participate in the exercise program
- •Individuals able and willing to provide written informed consent
- •Individuals able to operate a mobile phone independently or with assistance from a caregiver
排除标准
- •Individuals with cognitive impairment, defined as a Mini-Mental State Examination (MMSE) score < 20, or those unable to participate due to cognitive decline
- •Individuals with an implanted cardiac pacemaker or other implanted electronic medical device
- •Individuals with uncontrolled cardiovascular disease despite appropriate medical management
- •Individuals who have undergone lower-limb surgery within the past 6 months and are unable to ambulate independently
- •Individuals with moderate-to-severe musculoskeletal pain or functional limitations that interfere with objective functional assessments
- •Individuals with severe obesity, defined as a body mass index (BMI) > 50 kg/m²
- •Individuals currently receiving active cancer treatment or experiencing severe systemic frailty
- •Individuals with hemiplegia that prevents participation in the prescribed exercise program
- •Individuals who are anticipated by the investigator to be unable to complete the study procedures or follow-up assessments
- •Individuals unable to understand or comply with study instructions provided in Korean
- •Individuals considered unsuitable for study participation at the discretion of the investigator for any other reason
研究组 & 干预措施
Experimental Device Group (Home-based DTx exercise group after training)
Participants perform personalized resistance exercises using a digital therapeutic device (mobile application) at home for 12 weeks, with sessions conducted at least 3 times per week, 50 minutes per session (≥150 minutes/week). The program includes exercise automatic intensity adjustment, exercise recording/analysis, and physician monitoring
干预措施: exoDTx (Device)
Control Group (Self-exercise)
No mobile application is used. Participants perform the same type of exercise using QR code-based educational materials, self-regulating their exercise time, at least 3 times per week, 50 minutes per session, for a total of 12 weeks, with frequency and duration identical to the experimental group.
干预措施: Self-exercise (Educational Material) (Behavioral)
结局指标
主要结局
Change in peak knee extension strength (Nm) from baseline to 12 weeks
时间窗: 12 weeks after Visit 1 (treatment initiation)
Between-group comparison of mean change in knee extensor strength measured by lower extremity dynamometer.
次要结局
- Change in handgrip strength (kg) from baseline(Baseline, 4 weeks, 8 weeks, 12 weeks, and 24 weeks)
- Change in calf circumference (cm) from baseline(Baseline, 4 weeks, 8 weeks, 12 weeks, and 24 weeks)
- Change in 30-second chair stand test (repetitions) from baseline(12 weeks after Visit 1 (treatment initiation))
- Change in EQ-5D-5L index score from baseline(12 weeks after Visit 1 (treatment initiation))
- Change in Strength, Assistance with walking, Rise from a chair, Climb stairs, and Falls Questionnaire Score(Baseline, 4 weeks, 8 weeks, 12 weeks, and 24 weeks)
- Change in Sarcopenia Quality of Life score(Baseline, 4 weeks, 8 weeks, 12 weeks, and 24 weeks)
- Change in EuroQol Five-Dimension Five-Level (EQ-5D-5L) Questionnaire Score(12 weeks after Visit 1 (treatment initiation))
- Change in Short Physical Performance Battery (SPPB) total score and subscores (chair stand, gait speed, balance)(12 weeks after Visit 1 (treatment initiation))
- Change in body composition (skeletal muscle mass index, fat mass)(12 weeks after Visit 1 (treatment initiation))
- Change in peak isometric knee extension strength (Nm) from baseline to 4, 8, and 24 weeks(Baseline, 4 weeks, 8 weeks, and 24 weeks after Visit 1 (treatment initiation))
- Change in Manual Muscle Test (MMT) scores of major limb muscles(12 weeks after Visit 1 (treatment initiation))
- Change in Fugl-Meyer Assessment (upper/lower extremities; CNS-related sarcopenia subgroup)(12 weeks after Visit 1 (treatment initiation))
- Change in Functional Ambulation Category (FAC) score(12 weeks after Visit 1 (treatment initiation))
- Change in Berg Balance Scale (BBS) and Timed Up and Go (TUG) performance(12 weeks after Visit 1 (treatment initiation))
- Change in Muscle Function Index (MFI) from surface EMG analysis(12 weeks after Visit 1 (treatment initiation))
- Change in Sarcopenia Quality of Life (SarQOL) score(Baseline, 4 weeks, 8 weeks, 12 weeks, and 24 weeks)
- Change in Strength, Assistance with walking, Rise from a chair, Climb stairs, and Falls (SARC-F) Questionnaire Score(Baseline, 4 weeks, 8 weeks, 12 weeks, and 24 weeks)
- Change in Self-Efficacy for Home Exercise Programs Scale score(12 weeks after Visit 1 (treatment initiation))
- System Usability Scale (SUS) total score of the exoDTx mobile application(12 weeks after Visit 1 (treatment initiation))