Morphological and Functional Biomarkers of Skeletal Muscle Adaptations for Early Detection of Sarcopenia and of the Therapeutic Effects of a Home-Based Exercise Intervention: A Randomized-Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 192
- 试验地点
- 1
- 主要终点
- Change in 30-second Chair Stand Test performance
研究概览
简要总结
Sarcopenia is an age-related condition characterized by progressive loss of skeletal muscle mass, muscle strength, and physical performance. It is associated with frailty, falls, disability, reduced independence, lower quality of life, and increased healthcare burden. Despite its clinical relevance, sarcopenia remains underdiagnosed, partly because current diagnostic approaches may be difficult to implement broadly in clinical practice and may not fully capture early changes in muscle quality and neuromuscular function.
The EXEDOS study aims to evaluate an integrated diagnostic and therapeutic strategy for the early detection and management of sarcopenia. The study will assess Quantitative Ultrasound with Radio-Frequency analysis (QUS-RF) as a non-invasive, accessible, and radiation-free tool to characterize muscle morphology, microstructure, and quality. QUS-RF-derived parameters will be compared with established assessments, including body composition, muscle strength, physical performance, and imaging-based measures, to determine their feasibility, reliability, diagnostic accuracy, and responsiveness to change.
The study also includes a 48-week randomized, parallel-group, open-label superiority trial designed to evaluate the effects of a digitally delivered home-based exercise intervention in older adults with sarcopenia or at risk of sarcopenia. Eligible participants will be randomized to either an experimental group receiving a structured home-based exercise program or a control group receiving general physical activity recommendations in line with current guidelines. The exercise program will combine progressive resistance and aerobic training and will be supported by a digital platform allowing remote monitoring, feedback, and supervision. All participants will receive general nutritional advice.
Assessments will be performed at baseline, Week 12, and Week 48. The primary outcome of the randomized trial will be the change in 30-second Chair Stand Test performance, used as an indicator of lower-limb muscle function. Secondary outcomes will include handgrip strength, lower-limb maximal and explosive strength, walking capacity, balance, body composition, QUS-RF-derived muscle parameters, quality of life, mood, physical activity, dietary indicators, blood biomarkers, adherence to the intervention, and safety. A health economic analysis will also be conducted to estimate the potential cost-effectiveness and cost-utility of the proposed diagnostic and therapeutic strategy.
By combining innovative muscle assessment with a scalable digitally supported exercise intervention, the EXEDOS study aims to improve early sarcopenia detection, personalize exercise prescription, and support the development of sustainable strategies to preserve muscle function and independence in older adults.
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
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Sedentary individuals aged over 50 years.
- •Individuals with sarcopenia, defined as reduced muscle mass assessed by bioelectrical impedance analysis and reduced muscle strength assessed by handgrip strength, according to EWGSOP2 criteria.
- •Individuals at risk of sarcopenia, defined as reduced muscle mass with preserved muscle strength.
- •Healthy age-, sex-, and physical activity-matched older adults eligible for inclusion in the reference cohort.
- •Ability to understand the study procedures and provide written informed consent.
排除标准
- •Hospitalization within the previous 6 weeks.
- •Substance or alcohol abuse.
- •Use of medications that may impair balance or coordination.
- •Major locomotor impairments.
- •Inability to complete the exercise protocol.
- •Medical, cognitive, or functional conditions that, in the opinion of the investigators, may interfere with safe participation, adherence to the study procedures, or completion of the follow-up assessments.
研究组 & 干预措施
Sarcopenia - Exercise Intervention
Participants with sarcopenia allocated to the exercise group will receive a 48-week digitally delivered home-based exercise intervention. The program will include progressive resistance exercises using body weight and/or light external loads, combined with moderate-intensity aerobic training. Sessions will be performed three times per week for approximately 45 minutes per session. The intervention will be supported by a digital platform, wearable inertial sensors, heart-rate monitoring, instructional videos, automated feedback, and remote professional supervision. Participants will also receive general nutritional advice.
干预措施: Digitally delivered home-based exercise intervention (Behavioral)
Sarcopenia - Control
Participants with sarcopenia allocated to the control group will receive general physical activity recommendations in line with current WHO guidelines and general nutritional advice. They will not receive the digitally delivered individualized exercise intervention. Participants will undergo the same assessment schedule as the intervention group, including baseline, Week 12, and Week 48 evaluations of muscle strength, physical performance, balance, body composition, QUS-RF-derived muscle parameters, questionnaires, dietary monitoring, and blood biomarkers, according to the study protocol.
干预措施: General physical activity recommendations (Behavioral)
Pre-sarcopenia - Exercise Intervention
Participants at risk of sarcopenia, defined by reduced muscle mass with preserved muscle strength, allocated to the exercise group will receive a 48-week digitally delivered home-based exercise intervention. The program will combine progressive resistance training using body weight and/or light external loads with moderate-intensity aerobic training. Sessions will be performed three times per week for approximately 45 minutes per session. Training will be monitored through a digital platform including wearable inertial sensors, heart-rate monitoring, instructional videos, automated feedback, and remote professional supervision. Participants will also receive general nutritional advice.
干预措施: Digitally delivered home-based exercise intervention (Behavioral)
Pre-sarcopenia - Control
Participants at risk of sarcopenia, defined by reduced muscle mass with preserved muscle strength, allocated to the control group will receive general physical activity recommendations in line with current WHO guidelines and general nutritional advice. They will not receive the digitally delivered individualized exercise intervention. Participants will complete the same assessment schedule as the intervention group, including baseline, Week 12, and Week 48 evaluations of muscle strength, physical performance, balance, body composition, QUS-RF-derived muscle parameters, questionnaires, dietary monitoring, and blood biomarkers.
干预措施: General physical activity recommendations (Behavioral)
Healthy Reference Cohort
Healthy age-, sex-, and physical activity-matched older adults will be included as a non-randomized reference cohort. These participants will not receive the digitally delivered exercise intervention and will not be assigned to the control condition. They will undergo the scheduled study assessments to provide reference values for diagnostic and longitudinal comparisons, including evaluations of body composition, QUS-RF-derived muscle parameters, muscle strength, physical performance, balance, questionnaires, dietary monitoring, and blood biomarkers at the planned study time points.
结局指标
主要结局
Change in 30-second Chair Stand Test performance
时间窗: Baseline, Week 12, and Week 48
Lower-limb muscle function will be assessed using the 30-second Chair Stand Test. Participants will be asked to complete as many sit-to-stand repetitions as possible within 30 seconds using a standardized protocol. The outcome will be expressed as the number of complete repetitions. The primary analysis will evaluate changes from baseline to Week 12 and Week 48 between the exercise intervention and control groups.
次要结局
- Change in handgrip strength(Baseline, Week 12, and Week 48)
- Change in lower-limb explosive strength(Baseline, Week 12, and Week 48)
- Change in 6-Minute Walk Test distance(Baseline, Week 12, and Week 48)
- Change in Mini-Balance Evaluation Systems Test score(Baseline, Week 12, and Week 48)
- Change in fat mass assessed by bioelectrical impedance analysis(Fat mass will be assessed using bioelectrical impedance analysis according to standardized procedures. The outcome will be expressed in percentage. Changes from baseline to Week 12 and Week 48 will be evaluated.)
- Change in lean mass assessed by bioelectrical impedance analysis(Baseline, Week 12, and Week 48)
- Change in skeletal muscle mass index assessed by bioelectrical impedance analysis(Baseline, Week 12, and Week 48)
- Change in appendicular skeletal muscle mass index assessed by DEXA(Baseline and Week 48)
- Change in quantitative ultrasound radio-frequency-derived muscle echo-intensity parameters(Baseline, Week 12, and Week 48)
- Area under the receiver operating characteristic curve of quantitative ultrasound radio-frequency analysis for sarcopenia classification(Baseline)
- Change in 12-Item Short Form Health Survey Physical Component Summary score(Baseline, Week 12, and Week 48)
- Change in 12-Item Short Form Health Survey Mental Component Summary score(Baseline, Week 12, and Week 48)
- Change in mood state assessed by the Profile of Mood States(Mood state will be assessed using the Profile of Mood States questionnaire. The questionnaire will be used to evaluate psychological well-being and mood-related dimensions over the course of the study.)
- Change in blood biomarkers related to sarcopenia, inflammation, endocrine regulation, and muscle turnover(Baseline and Week 48)
- Change in appendicular skeletal muscle mass index assessed by dual-energy X-ray absorptiometry(Baseline and Week 48)
- Change in Profile of Mood States Total Mood Disturbance score(Baseline, Week 12, and Week 48)
- Change in C-reactive protein concentration(Baseline and Week 48)