Ultrasound Muscle Biomarkers as Predictors of Isometric Quadriceps Muscle Strength and Handgrip in Healthy Adults: an Observational Study

NCT07647393 | Not Yet Recruiting

• 1 other identifier: CEIP/2026/2/39
• Study Type: observational
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Healthy Adult; Muscle Strength; Skeletal Muscle Ultrasound

Keywords

Muscle ultrasound; Skeletal muscle ultrasonography; Muscle biomarkers; Isometric quadriceps muscle strength; Handgrip; Muscle thickness; Echo intensity; Muscle quality; Predictive models

Outcome Measures

Primary Outcomes (3)

• Isometric quadriceps muscle strength

  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

  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

  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

Secondary Outcomes (10)

• Five-repetition sit-to-stand test

  Day 1

• One-minute sit-to-stand test

  Day 1

• Timed Up and Go test

  Day 1

• Modified Medical Research Council dyspnoea scale

  Day 1

• Modified Borg dyspnoea scale

  Day 1

Other Outcomes (10)

• Age

  Day 1

• Weight

  Day 1

• Height

  Day 1

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alcala: lead

Study Officials

• Nicola S. Diciolla, PT, Ph.D.

  University of Alcalá

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicola S. Diciolla, PT, Ph.D.

CONTACT

+34 918 85 48 28; nicola.diciolla@uah.es

Beatriz Sánchez-Sánchez, PT, Ph.D.

CONTACT

+34 918 85 48 28; beatriz.sanchez@uah.es

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PT, Ph.D.

Study Record Dates

• First Submitted: June 9, 2026
• First Posted: June 15, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2029
• Last Updated: June 15, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: 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.
• Access Criteria: 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.