Morphological and Functional Biomarkers of Skeletal Muscle Adaptations in Sarcopenia (EXEDOS)
2026年7月9日 更新者：I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
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
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.
研究概览
地位
招聘中
条件
研究类型
介入性
注册 (估计的)
192
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Matteo Bonato, Ph.D.
- 电话号码：+390283502246
- 邮箱：matteo.bonato@unimi.it
研究联系人备份
- 姓名：Stefano Borghi, Ph.D.
- 邮箱：stefano.borghi@grupposandonato.it
学习地点
-
-
Mi
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Milan、Mi、意大利、20157
- 招聘中
- IRCCS Ospedale Galeazzi-Sant'Ambrogio
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接触：
- Stefano Borghi, Ph.D.
- 电话号码：+390283502246
- 邮箱：stefano.borghi@grupposandonato.it
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-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
是的
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：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.
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Digitally delivered, home-based, 48-week exercise program combining progressive resistance training and moderate-intensity aerobic training.
Participants will perform three sessions per week, each lasting approximately 45 minutes.
Resistance exercises will use body weight and/or light external loads and will follow progressive overload principles.
Aerobic exercise intensity will be adjusted using heart-rate feedback.
The intervention will be delivered through a certified digital therapeutic platform including instructional videos, wearable inertial sensors, heart-rate monitoring, automated feedback, and remote professional supervision through chat or video call.
Training progression will be individualized using adherence data, functional assessments, and monitoring outputs.
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|
有源比较器：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.
|
Participants allocated to the control condition 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 program, wearable sensor-based monitoring, automated feedback, or remote exercise supervision.
This intervention is intended to represent a standard recommendation-based comparator condition against which the digitally delivered home-based exercise intervention will be evaluated.
|
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实验性的：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.
|
Digitally delivered, home-based, 48-week exercise program combining progressive resistance training and moderate-intensity aerobic training.
Participants will perform three sessions per week, each lasting approximately 45 minutes.
Resistance exercises will use body weight and/or light external loads and will follow progressive overload principles.
Aerobic exercise intensity will be adjusted using heart-rate feedback.
The intervention will be delivered through a certified digital therapeutic platform including instructional videos, wearable inertial sensors, heart-rate monitoring, automated feedback, and remote professional supervision through chat or video call.
Training progression will be individualized using adherence data, functional assessments, and monitoring outputs.
|
|
有源比较器：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.
|
Participants allocated to the control condition 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 program, wearable sensor-based monitoring, automated feedback, or remote exercise supervision.
This intervention is intended to represent a standard recommendation-based comparator condition against which the digitally delivered home-based exercise intervention will be evaluated.
|
|
无干预：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.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in 30-second Chair Stand Test performance
大体时间：Baseline, Week 12, and Week 48
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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.
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Baseline, Week 12, and Week 48
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in handgrip strength
大体时间：Baseline, Week 12, and Week 48
|
Maximal handgrip strength will be assessed using a handgrip dynamometer according to a standardized protocol.
The outcome will be expressed in kilograms or Newtons, according to the device output.
Changes from baseline to Week 12 and Week 48 will be compared between groups.
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Baseline, Week 12, and Week 48
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Change in lower-limb explosive strength
大体时间：Baseline, Week 12, and Week 48
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Explosive strength and rapid force production will be assessed during lower-limb contractions using standardized dynamometric procedures.
The outcome will quantify the ability to rapidly generate force and will be used to characterize neuromuscular adaptations to the intervention.
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Baseline, Week 12, and Week 48
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Change in 6-Minute Walk Test distance
大体时间：Baseline, Week 12, and Week 48
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Functional walking capacity will be assessed using the 6-Minute Walk Test.
Participants will be instructed to walk as far as possible in 6 minutes according to a standardized protocol.
The outcome will be expressed as distance walked in meters.
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Baseline, Week 12, and Week 48
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Change in Mini-Balance Evaluation Systems Test score
大体时间：Baseline, Week 12, and Week 48
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Balance performance will be assessed using the Mini-Balance Evaluation Systems Test.
The total score ranges from 0 to 28 points, with higher scores indicating better balance performance.
Changes from baseline to Week 12 and Week 48 will be evaluated to assess intervention-related effects on balance.
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Baseline, Week 12, and Week 48
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Change in fat mass assessed by bioelectrical impedance analysis
大体时间：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.
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Baseline, Week 12, and Week 48
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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.
|
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Change in lean mass assessed by bioelectrical impedance analysis
大体时间：Baseline, Week 12, and Week 48
|
Lean 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.
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Baseline, Week 12, and Week 48
|
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Change in skeletal muscle mass index assessed by bioelectrical impedance analysis
大体时间：Baseline, Week 12, and Week 48
|
Skeletal muscle mass index will be assessed using bioelectrical impedance analysis according to standardized procedures.
The outcome will be expressed as kilograms per square meter.
Changes from baseline to Week 12 and Week 48 will be evaluated.
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Baseline, Week 12, and Week 48
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Change in quantitative ultrasound radio-frequency-derived muscle echo-intensity parameters
大体时间：Baseline, Week 12, and Week 48
|
Quantitative ultrasound radio-frequency analysis will be used to assess muscle quality and microstructure.
The primary QUS-RF parameter will be muscle echo-intensity, derived from standardized ultrasound acquisitions of selected lower-limb muscles.
The outcome will be expressed in arbitrary units or grayscale units, according to the image analysis output.
Changes from baseline to Week 12 and Week 48 will be evaluated and related to functional outcomes.
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Baseline, Week 12, and Week 48
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Area under the receiver operating characteristic curve of quantitative ultrasound radio-frequency analysis for sarcopenia classification
大体时间：Baseline
|
The diagnostic performance of quantitative ultrasound radio-frequency-derived muscle parameters for classifying sarcopenia status will be evaluated against reference criteria based on muscle mass and muscle strength.
Diagnostic accuracy will be expressed as the area under the receiver operating characteristic curve.
The area under the receiver operating characteristic curve ranges from 0.5 to 1.0 for a clinically useful classifier, with higher values indicating better diagnostic accuracy.
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Baseline
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Change in 12-Item Short Form Health Survey Physical Component Summary score
大体时间：Baseline, Week 12, and Week 48
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Health-related physical quality of life will be assessed using the 12-Item Short Form Health Survey Physical Component Summary score.
The score ranges from 0 to 100, with higher scores indicating better physical health-related quality of life.
Changes from baseline to Week 12 and Week 48 will be evaluated between groups.
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Baseline, Week 12, and Week 48
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Change in 12-Item Short Form Health Survey Mental Component Summary score
大体时间：Baseline, Week 12, and Week 48
|
Health-related mental quality of life will be assessed using the 12-Item Short Form Health Survey Mental Component Summary score.
The score ranges from 0 to 100, with higher scores indicating better mental health-related quality of life.
Changes from baseline to Week 12 and Week 48 will be evaluated between groups.
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Baseline, Week 12, and Week 48
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Change in appendicular skeletal muscle mass index assessed by dual-energy X-ray absorptiometry
大体时间：Baseline and Week 48
|
Appendicular skeletal muscle mass index will be assessed using dual-energy X-ray absorptiometry.
The index will be calculated as appendicular skeletal muscle mass divided by height squared and expressed in kilograms per square meter.
This is a continuous body composition parameter, not a scale score; therefore, no fixed minimum or maximum values apply.
Higher values indicate greater appendicular skeletal muscle mass relative to height.
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Baseline and Week 48
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Change in Profile of Mood States Total Mood Disturbance score
大体时间：Baseline, Week 12, and Week 48
|
Mood state will be assessed using the Profile of Mood States questionnaire.
The Total Mood Disturbance score will be calculated according to standard scoring procedures.
Higher scores indicate greater mood disturbance and therefore a worse mood-related outcome.
Changes from baseline to Week 12 and Week 48 will be evaluated between groups.
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Baseline, Week 12, and Week 48
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Change in C-reactive protein concentration
大体时间：Baseline and Week 48
|
Systemic inflammation will be assessed by measuring serum C-reactive protein concentration.
The outcome will be expressed in milligrams per liter.
Changes from baseline to Week 48 will be evaluated between groups.
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Baseline and Week 48
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年6月3日
初级完成 (估计的)
2027年6月3日
研究完成 (估计的)
2029年6月3日
研究注册日期
首次提交
2026年6月26日
首先提交符合 QC 标准的
2026年7月2日
首次发布 (实际的)
2026年7月9日
研究记录更新
最后更新发布 (实际的)
2026年7月13日
上次提交的符合 QC 标准的更新
2026年7月9日
最后验证
2026年7月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.