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Ultrasound Muscle Biomarkers as Predictors of Isometric Quadriceps Muscle Strength and Handgrip in Healthy Adults: an Observational Study (MUSCLE-US)

12 czerwca 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Szczegółowy opis

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.

Typ studiów

Obserwacyjny

Zapisy (Szacowany)

300

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Kopia zapasowa kontaktu do badania

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Tak

Metoda próbkowania

Próbka bez prawdopodobieństwa

Badana populacja

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.

Opis

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 studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Kohorty i interwencje

Grupa / Kohorta
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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Isometric quadriceps muscle strength
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Five-repetition sit-to-stand test
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
Age
Ramy czasowe: Day 1
Participant age recorded in completed years.
Day 1
Weight
Ramy czasowe: Day 1
Participant weight recorded in kilograms.
Day 1
Height
Ramy czasowe: Day 1
Participant height recorded in metres.
Day 1
Body mass index
Ramy czasowe: Day 1
Body mass index calculated as weight divided by height squared.
Day 1
Sex
Ramy czasowe: Day 1
Participant biological sex recorded as female or male.
Day 1
Systemic inflammation markers
Ramy czasowe: 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
Ramy czasowe: Day 1
Comorbidity burden assessed using the Charlson Comorbidity Index. Higher scores indicate greater comorbidity burden.
Day 1
Anatomical Therapeutic Chemical (ATC) Classification System
Ramy czasowe: Day 1
Current medication use classified according to the Anatomical Therapeutic Chemical (ATC) Classification System.
Day 1
Alcohol Use Disorders Identification Test-Consumption
Ramy czasowe: 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
Smoking Exposure (pack-year index)
Ramy czasowe: Day 1
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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

University of Alcala

Śledczy

  • Główny śledczy: Nicola S. Diciolla, PT, Ph.D., University of Alcala

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 czerwca 2026

Zakończenie podstawowe (Szacowany)

1 czerwca 2028

Ukończenie studiów (Szacowany)

1 czerwca 2029

Daty rejestracji na studia

Pierwszy przesłany

9 czerwca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

9 czerwca 2026

Pierwszy wysłany (Rzeczywisty)

15 czerwca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

16 czerwca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

12 czerwca 2026

Ostatnia weryfikacja

1 czerwca 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Inne numery identyfikacyjne badania

  • CEIP/2026/2/39

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Opis planu 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.

Ramy czasowe udostępniania 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.

Kryteria dostępu do udostępniania 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.

Typ informacji pomocniczych dotyczących udostępniania IPD

  • PROTOKÓŁ BADANIA
  • SOK ROŚLINNY
  • ICF
  • ANALITYCZNY_KOD

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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