Ultrasound Muscle Biomarkers as Predictors of Isometric Quadriceps Muscle Strength and Handgrip in Healthy Adults: an Observational Study (MUSCLE-US)
12 juin 2026 mis à jour par: Nicola S. Diciolla, University of Alcala
This observational study aims to determine whether ultrasound-derived muscle biomarkers can predict isometric quadriceps muscle strength and handgrip in healthy adults aged 18-89 years.
The main questions it aims to answer are:
- Which ultrasound muscle characteristics are associated with isometric quadriceps muscle strength and handgrip?
- Can ultrasound-derived biomarkers be used to develop predictive models of muscle strength in healthy adults?
Participants will undergo:
- Ultrasound assessment of the quadriceps and forearm flexor muscles;
- Measurement of isometric quadriceps muscle strength and handgrip using standardized dynamometry protocols;
- Assessment of functional capacity, mobility and balance;
- Completion of questionnaires related to health status, physical activity, nutrition, fatigue and health-related quality of life.
The study will also assess the reliability of ultrasound measurements and explore the relationship between ultrasound variables, muscle strength, physical function and health-related factors.
Aperçu de l'étude
Statut
Pas encore de recrutement
Description détaillée
Peripheral muscle strength is an important determinant of physical function, independence and health outcomes. Reduced quadriceps muscle strength and handgrip have been associated with functional limitations, frailty, hospitalization and mortality. Although muscle ultrasound is increasingly used to assess muscle morphology and quality, its ability to predict muscle strength remains incompletely understood.
The MUSCLE-US study is a monocentre observational study designed to investigate the relationship between ultrasound-derived muscle biomarkers and isometric quadriceps muscle strength and handgrip in healthy adults. Participants aged 18-89 years will be recruited from community settings and stratified by age and sex.
Ultrasound assessments will be performed on the quadriceps and forearm flexor muscles using standardized acquisition procedures. First-order variables (e.g., muscle thickness, cross-sectional area, pennation angle, fascicle length), second-order texture features and higher-order ultrasound biomarkers will be extracted and analysed.
Isometric quadriceps muscle strength and handgrip will be measured using standardized dynamometry protocols. Additional assessments will include functional capacity tests, mobility and balance measures, physical activity, nutritional status, fatigue, dyspnoea, health-related quality of life, lifestyle factors and comorbidity profiles.
The primary objective is to identify ultrasound biomarkers associated with quadriceps muscle strength and handgrip, and to develop predictive models of muscle strength. Secondary objectives include assessment of ultrasound measurement reliability and exploration of relationships between ultrasound biomarkers, muscle strength, physical function and health-related characteristics.
Recruitment, assessor training, ultrasound standardisation procedures and reliability analyses will be conducted during the initial phase of the project, followed by the main recruitment and data collection phase and subsequent statistical modelling and dissemination activities.
Type d'étude
Observationnel
Inscription (Estimé)
300
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Nicola S. Diciolla, PT, Ph.D.
- Numéro de téléphone: +34 918 85 48 28
- E-mail: nicola.diciolla@uah.es
Sauvegarde des contacts de l'étude
- Nom: Beatriz Sánchez-Sánchez, PT, Ph.D.
- Numéro de téléphone: +34 918 85 48 28
- E-mail: beatriz.sanchez@uah.es
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Oui
Méthode d'échantillonnage
Échantillon non probabiliste
Population étudiée
Community-dwelling healthy adults aged 18-89 years residing in Spain.
Participants will be recruited through community advertisements, institutional dissemination channels, and collaborating centres.
The study aims to investigate the relationship between ultrasound-derived muscle biomarkers and isometric quadriceps muscle strength and handgrip in a healthy adult population.
La description
Inclusion Criteria:
- Healthy adults aged 18-89 years.
- Resident in Spain for at least 5 years.
- Living independently in the community and able to complete all study assessments.
- Able to understand and follow verbal instructions in Spanish.
- Able and willing to provide written informed consent prior to study participation.
Exclusion Criteria:
- Neurological, musculoskeletal, or systemic disorders affecting muscle strength or mobility.
- Recent surgery or acute injury affecting the upper or lower limbs.
- Recent use of medications affecting the musculoskeletal system (e.g., systemic corticosteroids for >1 week during the previous 6 months or muscle relaxants during the previous week).
- Cognitive or psychiatric conditions limiting participation.
- Pregnancy.
- Recent postpartum period (≤3 months after delivery).
- Presence of clinically relevant pain, fatigue, physical deconditioning, or functional limitations that may interfere with study procedures or measurement validity.
- Acute illness at the time of assessment.
- Uncontrolled hypertension (≥140/90 mmHg).
- Resting peripheral oxygen saturation ≤90%.
- Moderate-to-severe pain (Numeric Rating Scale ≥4/10).
- Any medical condition considered by the investigator to contraindicate study participation.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
|---|
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Healthy adults
Healthy/community-dwelling adults aged 18-89 years participating in an observational study evaluating ultrasound-derived muscle biomarkers and their relationship with isometric quadriceps muscle strength and handgrip.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Isometric quadriceps muscle strength
Délai: Day 1
|
Quadricpes maximal voluntary contraction measured using a handheld dynamometer according to a standardized testing protocol.
Peak force will be recorded in kilograms-force (kgf).
|
Day 1
|
|
Handgrip
Délai: Day 1
|
Maximal voluntary handgrip measured using a hydraulic hand dynamometer according to the American Society of Hand Therapists protocol.
Peak force will be recorded in kilograms-force (kgf).
|
Day 1
|
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Ultrasound-derived muscle biomarkers
Délai: Day 1
|
Muscle ultrasound biomarkers obtained from standardized B-mode ultrasound images of selected quadriceps and forearm muscles.
Candidate variables include muscle morphology, architecture, grayscale characteristics and texture-based parameters.
The final set of ultrasound-derived biomarkers will be defined following assessor training, protocol standardization and pilot reliability analyses.
|
Day 1
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Five-repetition sit-to-stand test
Délai: Day 1
|
Functional capacity assessed by the time required to complete five sit-to-stand repetitions according to standardised procedures.
Results will be expressed in seconds.
Lower values indicate better lower-limb functional capacity.
|
Day 1
|
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One-minute sit-to-stand test
Délai: Day 1
|
Functional capacity assessed as the number of sit-to-stand repetitions completed in one minute according to standardised procedures.
Higher values indicate better functional exercise capacity.
|
Day 1
|
|
Timed Up and Go test
Délai: Day 1
|
Mobility and dynamic balance assessed using the Timed Up and Go test.
Results will be expressed in seconds.
Lower values indicate better mobility and dynamic balance.
|
Day 1
|
|
Modified Medical Research Council dyspnoea scale
Délai: Day 1
|
Dyspnoea severity assessed using the modified Medical Research Council dyspnoea scale.
Scores range from 0 to 4, with higher scores indicating greater breathlessness.
|
Day 1
|
|
Modified Borg dyspnoea scale
Délai: Day 1
|
Perceived breathlessness assessed using the modified Borg dyspnoea scale.
Scores range from 0 to 10, with higher scores indicating greater breathlessness.
|
Day 1
|
|
Dyspnoea-12
Délai: Day 1
|
Dyspnoea assessed using the Dyspnoea-12 questionnaire.
The total score ranges from 0 to 36, with higher scores indicating more severe breathlessness.
|
Day 1
|
|
Functional Assessment of Chronic Illness Therapy-Fatigue
Délai: Day 1
|
Fatigue assessed using the Functional Assessment of Chronic Illness Therapy-Fatigue questionnaire.
Scores range from 0 to 52, with higher scores indicating less fatigue.
|
Day 1
|
|
EuroQol 5-Dimension 5-Level
Délai: Day 1
|
Health-related quality of life assessed using the EuroQol 5-Dimension 5-Level (EQ-5D) questionnaire.
The index score will be calculated according to the appropriate national value set.
Higher scores indicate better health status.
Self-rated health assessed using the EQ-5D Visual Analogue Scale.
Scores range from 0 to 100, with higher scores indicating better perceived health.
|
Day 1
|
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International Physical Activity Questionnaire-short form
Délai: Day 1
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Physical activity assessed using the International Physical Activity Questionnaire-short form.
Results will be expressed as minutes per week spent in vigorous/moderate/total physical activity, time per week spent walking and hours per day spent in sedentary behaviour (sitting).
|
Day 1
|
|
Mini Nutritional Assessment-short form
Délai: Day 1
|
Nutritional status assessed using the Mini Nutritional Assessment-short form.
Scores range from 0 to 14, with higher scores indicating better nutritional status.
|
Day 1
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Age
Délai: Day 1
|
Participant age recorded in completed years.
|
Day 1
|
|
Weight
Délai: Day 1
|
Participant weight recorded in kilograms.
|
Day 1
|
|
Height
Délai: Day 1
|
Participant height recorded in metres.
|
Day 1
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Body mass index
Délai: Day 1
|
Body mass index calculated as weight divided by height squared.
|
Day 1
|
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Sex
Délai: Day 1
|
Participant biological sex recorded as female or male.
|
Day 1
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Systemic inflammation markers
Délai: Day 1
|
CRP, IL-6, eosinophils, fibrinogen, neutrophil elastase, ESR, KL-6, SP-D, FeNO, IgE, calprotectin, if available, from medical records.
|
Day 1
|
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Charlson Comorbidity Index
Délai: Day 1
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Comorbidity burden assessed using the Charlson Comorbidity Index.
Higher scores indicate greater comorbidity burden.
|
Day 1
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Anatomical Therapeutic Chemical (ATC) Classification System
Délai: Day 1
|
Current medication use classified according to the Anatomical Therapeutic Chemical (ATC) Classification System.
|
Day 1
|
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Alcohol Use Disorders Identification Test-Consumption
Délai: Day 1
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Alcohol consumption assessed using the Alcohol Use Disorders Identification Test-Consumption (AUDIT-C).
Higher scores indicate greater alcohol consumption and increased risk of hazardous drinking.
|
Day 1
|
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Smoking Exposure (pack-year index)
Délai: Day 1
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Lifetime smoking exposure quantified using the pack-year index, calculated from self-reported smoking history.
A higher pack-year index means greater cumulative exposure to tobacco smoking over lifetime.
|
Day 1
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Nicola S. Diciolla, PT, Ph.D., University of Alcala
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
1 juin 2026
Achèvement primaire (Estimé)
1 juin 2028
Achèvement de l'étude (Estimé)
1 juin 2029
Dates d'inscription aux études
Première soumission
9 juin 2026
Première soumission répondant aux critères de contrôle qualité
9 juin 2026
Première publication (Réel)
15 juin 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
16 juin 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
12 juin 2026
Dernière vérification
1 juin 2026
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- CEIP/2026/2/39
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
OUI
Description du régime IPD
Individual participant data (IPD) that underlie the results reported in publications, after de-identification, will be made available.
Shared data may include demographic characteristics, anthropometric variables, isometric quadriceps muscle strength, handgrip, ultrasound-derived muscle variables, functional capacity measures, and patient-reported outcomes/questionnaire data collected as part of the study.
Direct identifiers will be removed before data sharing.
Data sharing will comply with applicable ethical approvals, informed consent provisions, and data protection regulations.
Délai de partage IPD
De-identified individual participant data and supporting documents will become available beginning 12 months after publication of the primary study results and will remain available for at least 5 years thereafter.
Critères d'accès au partage IPD
Researchers who provide a methodologically sound proposal for secondary analyses or validation studies may request access to the de-identified dataset.
Requests will be reviewed by the study investigators.
Data will be provided following approval of the proposal and execution of a data-sharing agreement, when required, in accordance with ethical and legal requirements.
Supporting documents, including the study protocol, statistical analysis plan, informed consent form template, and analytic code, will be made available upon reasonable request.
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- SÈVE
- CIF
- ANALYTIC_CODE
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .