Ultrasound Muscle Biomarkers as Predictors of Isometric Quadriceps Muscle Strength and Handgrip in Healthy Adults: an Observational Study (MUSCLE-US)
9 giugno 2026 aggiornato da: 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.
Panoramica dello studio
Stato
Non ancora reclutamento
Descrizione dettagliata
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.
Tipo di studio
Osservativo
Iscrizione (Stimato)
300
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Nicola S. Diciolla, PT, Ph.D.
- Numero di telefono: +34 918 85 48 28
- Email: nicola.diciolla@uah.es
Backup dei contatti dello studio
- Nome: Beatriz Sánchez-Sánchez, PT, Ph.D.
- Numero di telefono: +34 918 85 48 28
- Email: beatriz.sanchez@uah.es
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Sì
Metodo di campionamento
Campione non probabilistico
Popolazione di studio
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.
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
|---|
|
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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Isometric quadriceps muscle strength
Lasso di tempo: 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
Lasso di tempo: 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
|
|
Ultrasound-derived muscle biomarkers
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Five-repetition sit-to-stand test
Lasso di tempo: 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
|
|
One-minute sit-to-stand test
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
|
|
International Physical Activity Questionnaire-short form
Lasso di tempo: Day 1
|
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
Lasso di tempo: 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
|
Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Age
Lasso di tempo: Day 1
|
Participant age recorded in completed years.
|
Day 1
|
|
Weight
Lasso di tempo: Day 1
|
Participant weight recorded in kilograms.
|
Day 1
|
|
Height
Lasso di tempo: Day 1
|
Participant height recorded in metres.
|
Day 1
|
|
Body mass index
Lasso di tempo: Day 1
|
Body mass index calculated as weight divided by height squared.
|
Day 1
|
|
Sex
Lasso di tempo: Day 1
|
Participant biological sex recorded as female or male.
|
Day 1
|
|
Systemic inflammation markers
Lasso di tempo: Day 1
|
CRP, IL-6, eosinophils, fibrinogen, neutrophil elastase, ESR, KL-6, SP-D, FeNO, IgE, calprotectin, if available, from medical records.
|
Day 1
|
|
Charlson Comorbidity Index
Lasso di tempo: Day 1
|
Comorbidity burden assessed using the Charlson Comorbidity Index.
Higher scores indicate greater comorbidity burden.
|
Day 1
|
|
Anatomical Therapeutic Chemical (ATC) Classification System
Lasso di tempo: Day 1
|
Current medication use classified according to the Anatomical Therapeutic Chemical (ATC) Classification System.
|
Day 1
|
|
Smoking Exposure (pack-year index)
Lasso di tempo: Day 1
|
Lifetime smoking exposure quantified using the pack-year index, calculated from self-reported smoking history.
|
Day 1
|
|
Alcohol Use Disorders Identification Test-Consumption
Lasso di tempo: Day 1
|
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
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Investigatore principale: Nicola S. Diciolla, PT, Ph.D., University of Alcalá
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Stimato)
1 giugno 2026
Completamento primario (Stimato)
1 giugno 2028
Completamento dello studio (Stimato)
1 giugno 2029
Date di iscrizione allo studio
Primo inviato
9 giugno 2026
Primo inviato che soddisfa i criteri di controllo qualità
9 giugno 2026
Primo Inserito (Effettivo)
15 giugno 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
15 giugno 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
9 giugno 2026
Ultimo verificato
1 giugno 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- CEIP/2026/2/39
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
SÌ
Descrizione del piano 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.
Periodo di condivisione 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.
Criteri di accesso alla condivisione 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.
Tipo di informazioni di supporto alla condivisione IPD
- STUDIO_PROTOCOLLO
- LINFA
- ICF
- CODICE_ANALITICO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .