NCT07726498

Brief Summary

The calf muscles (plantarflexors) are the most important muscles for walking, running and daily activities. Weakness of these muscles through aging and disease significantly impact a person's ability to walk and complete daily activities. By assessing calf strength, it is possible to identify people at risk of falls, and a condition called sarcopenia (which means loss of muscle mass, strength and function). Unfortunately, most of the studies that have examined this have used specialist equipment unavailable to hospital staff. Our study aims to use commercially available equipment to explore the relationship between plantarflexor muscle strength and physical performance in adults living with or without sarcopenia, including those at risk of it. The study will determine if stronger/weaker calf muscles associated with sarcopenia influence the ability to walk and do things more easily. We will complete strength tests of the calf, thigh and hand, assess walking using a special camera system, use an ultrasound scan to look at the Achilles tendon, use a scan to look at how stiff your calf muscles are, assess your body composition, complete a physical performance test and some questionnaires. Each participant will complete the measures during one clinic visit

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
19mo left

Started Aug 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 17, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 24, 2026

Completed
8 days until next milestone

Study Start

First participant enrolled

August 1, 2026

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 29, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 29, 2028

Last Updated

July 24, 2026

Status Verified

July 1, 2026

Enrollment Period

1.6 years

First QC Date

July 17, 2026

Last Update Submit

July 22, 2026

Conditions

Keywords

PlantarflexorsSarcopeniaAgingWeaknessMulti-morbidity

Outcome Measures

Primary Outcomes (1)

  • Isometric plantarflexor strength testing

    Isometric plantarflexor strength will be tested using the Fysiometer C-station

    Baseline

Secondary Outcomes (11)

  • Theia markerless motion capture system

    Baseline

  • Ultrasound Tissue Characterization Imaging

    Baseline

  • Elastography

    Baseline

  • Grip strength

    Baseline

  • Isometric Knee Extension Strength Test

    Baseline

  • +6 more secondary outcomes

Study Arms (2)

Sarcopenic

Other: No intervention (observational study)

Non Sarcopenic

Other: No intervention (observational study)

Interventions

No intervention (observational study)

Non SarcopenicSarcopenic

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population is individuals over the age of 18 years, who may or may not have sarcopenia. Individuals will be determined as either sarcopenic or non-sarcopenic by completing the outcome measures (SARC-F questionnaire, Grip strength, BIA and SPPB) and using the cut-off values as recommended by the European Working Group on Sarcopenia in Older People 2 consensus.

You may qualify if:

  • Participant is able and willing to provide informed consent to participate in the study
  • Aged 18 years or over
  • Ambulatory status: able to walk independently with or without aids
  • Able to attend clinic

You may not qualify if:

  • Participant is unwilling or unable to give informed consent.
  • Palliative/ end of life
  • Moderate to severe communication difficulties/ cognitive function
  • Immobile
  • Lower limb surgery within the last 6 months
  • Recent lower limb fracture
  • Unstable cardiopulmonary conditions
  • Severe impairments of vision or vestibular system
  • Lower limb corticosteroid injection within the last 6 months
  • No restriction on language

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Leicester

Leicester, LE1 7RH, United Kingdom

Location

MeSH Terms

Conditions

SarcopeniaMuscle WeaknessAtrophyFrailtyAsthenia

Interventions

Observation

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and SymptomsMuscular DiseasesMusculoskeletal DiseasesPathologic Processes

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2026

First Posted

July 24, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

February 29, 2028

Study Completion (Estimated)

February 29, 2028

Last Updated

July 24, 2026

Record last verified: 2026-07

Locations