Ultrasound Muscle Biomarkers as Predictors of Isometric Quadriceps Muscle Strength and Handgrip in Healthy Adults: an Observational Study (MUSCLE-US)
12 de junho de 2026 atualizado por: 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.
Visão geral do estudo
Status
Ainda não está recrutando
Descrição detalhada
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 de estudo
Observacional
Inscrição (Estimado)
300
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Nicola S. Diciolla, PT, Ph.D.
- Número de telefone: +34 918 85 48 28
- E-mail: nicola.diciolla@uah.es
Estude backup de contato
- Nome: Beatriz Sánchez-Sánchez, PT, Ph.D.
- Número de telefone: +34 918 85 48 28
- E-mail: beatriz.sanchez@uah.es
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Sim
Método de amostragem
Amostra Não Probabilística
População do estudo
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.
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
|---|
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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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Isometric quadriceps muscle strength
Prazo: Day 1
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Quadricpes maximal voluntary contraction measured using a handheld dynamometer according to a standardized testing protocol.
Peak force will be recorded in kilograms-force (kgf).
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Day 1
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Handgrip
Prazo: Day 1
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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
Prazo: Day 1
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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.
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Day 1
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Five-repetition sit-to-stand test
Prazo: Day 1
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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.
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Day 1
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One-minute sit-to-stand test
Prazo: Day 1
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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
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Timed Up and Go test
Prazo: Day 1
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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
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Modified Medical Research Council dyspnoea scale
Prazo: Day 1
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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
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Modified Borg dyspnoea scale
Prazo: Day 1
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Perceived breathlessness assessed using the modified Borg dyspnoea scale.
Scores range from 0 to 10, with higher scores indicating greater breathlessness.
|
Day 1
|
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Dyspnoea-12
Prazo: 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
|
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Functional Assessment of Chronic Illness Therapy-Fatigue
Prazo: 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
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EuroQol 5-Dimension 5-Level
Prazo: Day 1
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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.
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Day 1
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International Physical Activity Questionnaire-short form
Prazo: 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).
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Day 1
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Mini Nutritional Assessment-short form
Prazo: Day 1
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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
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Age
Prazo: Day 1
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Participant age recorded in completed years.
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Day 1
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Weight
Prazo: Day 1
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Participant weight recorded in kilograms.
|
Day 1
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Height
Prazo: Day 1
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Participant height recorded in metres.
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Day 1
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Body mass index
Prazo: Day 1
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Body mass index calculated as weight divided by height squared.
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Day 1
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Sex
Prazo: Day 1
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Participant biological sex recorded as female or male.
|
Day 1
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Systemic inflammation markers
Prazo: Day 1
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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
Prazo: Day 1
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Comorbidity burden assessed using the Charlson Comorbidity Index.
Higher scores indicate greater comorbidity burden.
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Day 1
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Anatomical Therapeutic Chemical (ATC) Classification System
Prazo: Day 1
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Current medication use classified according to the Anatomical Therapeutic Chemical (ATC) Classification System.
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Day 1
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Alcohol Use Disorders Identification Test-Consumption
Prazo: 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.
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Day 1
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Smoking Exposure (pack-year index)
Prazo: 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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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Nicola S. Diciolla, PT, Ph.D., University of Alcala
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Estimado)
1 de junho de 2026
Conclusão Primária (Estimado)
1 de junho de 2028
Conclusão do estudo (Estimado)
1 de junho de 2029
Datas de inscrição no estudo
Enviado pela primeira vez
9 de junho de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
9 de junho de 2026
Primeira postagem (Real)
15 de junho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
16 de junho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
12 de junho de 2026
Última verificação
1 de junho de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- CEIP/2026/2/39
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano 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.
Prazo de Compartilhamento de 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.
Critérios de acesso de compartilhamento 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 de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
- CIF
- ANALYTIC_CODE
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .