Ultrasound Muscle Biomarkers as Predictors of Isometric Quadriceps Muscle Strength and Handgrip in Healthy Adults: an Observational Study (MUSCLE-US)
perjantai 12. kesäkuuta 2026 päivittänyt: 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.
Tutkimuksen yleiskatsaus
Tila
Ei vielä rekrytointia
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Havainnollistava
Ilmoittautuminen (Arvioitu)
300
Yhteystiedot ja paikat
Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.
Opiskeluyhteys
- Nimi: Nicola S. Diciolla, PT, Ph.D.
- Puhelinnumero: +34 918 85 48 28
- Sähköposti: nicola.diciolla@uah.es
Tutki yhteystietojen varmuuskopiointi
- Nimi: Beatriz Sánchez-Sánchez, PT, Ph.D.
- Puhelinnumero: +34 918 85 48 28
- Sähköposti: beatriz.sanchez@uah.es
Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Aikuinen
- Vanhempi Aikuinen
Hyväksyy terveitä vapaaehtoisia
Joo
Näytteenottomenetelmä
Ei-todennäköisyysnäyte
Tutkimusväestö
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.
Kuvaus
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.
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
Kohortit ja interventiot
Ryhmä/Kohortti |
|---|
|
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.
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Isometric quadriceps muscle strength
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Five-repetition sit-to-stand test
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
|
Muut tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Age
Aikaikkuna: Day 1
|
Participant age recorded in completed years.
|
Day 1
|
|
Weight
Aikaikkuna: Day 1
|
Participant weight recorded in kilograms.
|
Day 1
|
|
Height
Aikaikkuna: Day 1
|
Participant height recorded in metres.
|
Day 1
|
|
Body mass index
Aikaikkuna: Day 1
|
Body mass index calculated as weight divided by height squared.
|
Day 1
|
|
Sex
Aikaikkuna: Day 1
|
Participant biological sex recorded as female or male.
|
Day 1
|
|
Systemic inflammation markers
Aikaikkuna: 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
Aikaikkuna: Day 1
|
Comorbidity burden assessed using the Charlson Comorbidity Index.
Higher scores indicate greater comorbidity burden.
|
Day 1
|
|
Anatomical Therapeutic Chemical (ATC) Classification System
Aikaikkuna: Day 1
|
Current medication use classified according to the Anatomical Therapeutic Chemical (ATC) Classification System.
|
Day 1
|
|
Alcohol Use Disorders Identification Test-Consumption
Aikaikkuna: 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)
Aikaikkuna: 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
|
Yhteistyökumppanit ja tutkijat
Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.
Sponsori
Tutkijat
- Päätutkija: Nicola S. Diciolla, PT, Ph.D., University of Alcala
Opintojen ennätyspäivät
Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan julkisella verkkosivustolla.
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Arvioitu)
Maanantai 1. kesäkuuta 2026
Ensisijainen valmistuminen (Arvioitu)
Torstai 1. kesäkuuta 2028
Opintojen valmistuminen (Arvioitu)
Perjantai 1. kesäkuuta 2029
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Tiistai 9. kesäkuuta 2026
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Tiistai 9. kesäkuuta 2026
Ensimmäinen Lähetetty (Todellinen)
Maanantai 15. kesäkuuta 2026
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Tiistai 16. kesäkuuta 2026
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Perjantai 12. kesäkuuta 2026
Viimeksi vahvistettu
Maanantai 1. kesäkuuta 2026
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muut tutkimustunnusnumerot
- CEIP/2026/2/39
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
JOO
IPD-suunnitelman kuvaus
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.
IPD-jaon aikakehys
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.
IPD-jaon käyttöoikeuskriteerit
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.
IPD-jakamista tukeva tietotyyppi
- STUDY_PROTOCOL
- MAHLA
- ICF
- ANALYTIC_CODE
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Ei
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
Ei
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .