Morphological and Functional Biomarkers of Skeletal Muscle Adaptations in Sarcopenia (EXEDOS)
9 de julio de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Tipo de estudio
Intervencionista
Inscripción (Estimado)
192
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Matteo Bonato, Ph.D.
- Número de teléfono: +390283502246
- Correo electrónico: matteo.bonato@unimi.it
Copia de seguridad de contactos de estudio
- Nombre: Stefano Borghi, Ph.D.
- Correo electrónico: stefano.borghi@grupposandonato.it
Ubicaciones de estudio
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Mi
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Milan, Mi, Italia, 20157
- Reclutamiento
- IRCCS Ospedale Galeazzi-Sant'Ambrogio
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Contacto:
- Stefano Borghi, Ph.D.
- Número de teléfono: +390283502246
- Correo electrónico: stefano.borghi@grupposandonato.it
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-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Sí
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 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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Comparador activo: 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.
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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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Experimental: 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.
|
|
Comparador activo: 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.
|
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Sin intervención: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in 30-second Chair Stand Test performance
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in handgrip strength
Periodo de tiempo: Baseline, Week 12, and Week 48
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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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: Baseline, Week 12, and Week 48
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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
Periodo de tiempo: Baseline, Week 12, and Week 48
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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
Periodo de tiempo: Baseline, Week 12, and Week 48
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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
Periodo de tiempo: Baseline
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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
Periodo de tiempo: 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
Periodo de tiempo: Baseline, Week 12, and Week 48
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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
Periodo de tiempo: Baseline and Week 48
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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
Periodo de tiempo: Baseline, Week 12, and Week 48
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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
Periodo de tiempo: Baseline and Week 48
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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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
3 de junio de 2026
Finalización primaria (Estimado)
3 de junio de 2027
Finalización del estudio (Estimado)
3 de junio de 2029
Fechas de registro del estudio
Enviado por primera vez
26 de junio de 2026
Primero enviado que cumplió con los criterios de control de calidad
2 de julio de 2026
Publicado por primera vez (Actual)
9 de julio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
13 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
9 de julio de 2026
Última verificación
1 de julio de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- GR-2024-12378411
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .