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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 juni 2026 uppdaterad av: 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.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Beräknad)

300

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studera Kontakt Backup

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Ja

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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.

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Isometric quadriceps muscle strength
Tidsram: 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
Tidsram: 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
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Five-repetition sit-to-stand test
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Andra resultatmått

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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

University of Alcala

Utredare

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

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 juni 2026

Primärt slutförande (Beräknad)

1 juni 2028

Avslutad studie (Beräknad)

1 juni 2029

Studieregistreringsdatum

Först inskickad

9 juni 2026

Först inskickad som uppfyllde QC-kriterierna

9 juni 2026

Första postat (Faktisk)

15 juni 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

16 juni 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

12 juni 2026

Senast verifierad

1 juni 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Andra studie-ID-nummer

  • CEIP/2026/2/39

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

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.

Tidsram för IPD-delning

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.

Kriterier för IPD Sharing Access

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-delning som stöder informationstyp

  • STUDY_PROTOCOL
  • SAV
  • ICF
  • ANALYTIC_CODE

Läkemedels- och apparatinformation, studiedokument

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Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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