- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07726498
STRIDE: Strength of The Calf Muscles and Their Role In Declining Effectiveness of Movement With Aging (STRIDE)
July 22, 2026 updated by: University of Leicester
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
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
This study aims to assess the relationship between plantarflexor (calf muscles) muscle strength and physical performance between people with and without sarcopenia.
The measurements include Isometric plantarflexor strength testing, Theia markerless motion capture system, Ultrasound Tissue Characterization Imaging, Elastography, Grip strength, Isometric Knee Extension Strength Test, Bioelectrical Impedance analysis, Short Physical Performance Battery.
In addition the SARC-F, Falls Efficacy Scale- International (FES-I), EuroQol- 5 Dimension (EQ-5D-5L) and Short-Form-12-health-survey (SF-12) questionnaires will be completed.
Study Type
Observational
Enrollment (Estimated)
200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Leicester, United Kingdom, LE1 7RH
- University of Leicester
-
Contact:
- Matt Harrison, BSc MA
- Email: mch58@leicester.ac.uk
-
Principal Investigator:
- Seth O'Neill, PhD
-
Sub-Investigator:
- Matt Harrison, BSc MA
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-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.
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Sarcopenic
|
No intervention (observational study)
|
|
Non Sarcopenic
|
No intervention (observational study)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Isometric plantarflexor strength testing
Time Frame: Baseline
|
Isometric plantarflexor strength will be tested using the Fysiometer C-station
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Theia markerless motion capture system
Time Frame: Baseline
|
Gait will be assessed using Theia 3D (Theia Markerless Inc., Kingston, ON, Canada).
Theia 3D is a commercial markerless motion capture system which uses multiple cameras to capture video footage of physical performance, tracking 124 keypoints producing 3D models.
Calibration it completed prior to recording.
Data is processed in Theia 3D and analysed in Visual 3D software.
Measures such as gait speed and pattern, forces, joint angles, stride length and cadence will be collected.
|
Baseline
|
|
Ultrasound Tissue Characterization Imaging
Time Frame: Baseline
|
Imaging of the Achilles Tendon to identify structural changes to the Achilles tendon.
|
Baseline
|
|
Elastography
Time Frame: Baseline
|
Imaging of the Plantarflexors and Achilles Tendon to understand muscle stiffness and tissue mechanical properties
|
Baseline
|
|
Grip strength
Time Frame: Baseline
|
A Jamar hand dynamometer will be used, measuring grip strength in kilograms
|
Baseline
|
|
Isometric Knee Extension Strength Test
Time Frame: Baseline
|
Isometric Knee Extension strength will be measured using Kinvent K-Pull incline dynamometer
|
Baseline
|
|
Bioelectrical Impedance analysis
Time Frame: Baseline
|
Bioelectrical impedance analysis (BIA) will be used to estimate body composition and Skeletal Muscle Mass.
|
Baseline
|
|
Short Physical Performance Battery
Time Frame: Baseline
|
It consists of three key components: balance tests, gait speed and chair stand test.
Participants who are unable to complete a component score 0, whereas a score of 4 indicates highest performance of that component.
Each component is scored out of 4 points with a maximum combined score of 12 points.
|
Baseline
|
|
SARC-F questionnaire
Time Frame: Baseline
|
The questionnaire contains 5 questions/components, covering strength, assistance with walking, rise from a chair, climb stairs and falls.
Each component is scored ranging from 0 to 2 points, with a minimum combined score of 0 and a maximal combined score of 10.
A score equal to or greater than 4 is predictive of sarcopenia and poor outcomes.
|
Baseline
|
|
Falls Efficacy Scale- International (FES-I)
Time Frame: Baseline
|
The questionnaire contains sixteen questions/items.
Each question/item is scored on a four-point Likert scale (1- not at all concerned; 2- somewhat concerned; 3- fairly concerned; 4- very concerned).
The total score ranges from 16-64.
|
Baseline
|
|
EuroQol- 5 Dimension (EQ-5D-5L)
Time Frame: Baseline
|
It consists of five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) and a visual analogue scale where individuals rate their overall health on a scale of 0-100.
|
Baseline
|
|
Short-Form-12-health-survey (SF-12)
Time Frame: Baseline
|
It measures eight domains, covering physical functioning, role physical, bodily pain, general health perception, energy/vitality, social functioning, role emotional and mental health.
Two summary scores are reported (Physical Component Summary and Mental Component Summary).
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
August 1, 2026
Primary Completion (Estimated)
February 29, 2028
Study Completion (Estimated)
February 29, 2028
Study Registration Dates
First Submitted
July 17, 2026
First Submitted That Met QC Criteria
July 22, 2026
First Posted (Actual)
July 24, 2026
Study Record Updates
Last Update Posted (Actual)
July 24, 2026
Last Update Submitted That Met QC Criteria
July 22, 2026
Last Verified
July 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Musculoskeletal Diseases
- Nervous System Diseases
- Muscular Diseases
- Neuromuscular Manifestations
- Pathologic Processes
- Pathological Conditions, Anatomical
- Muscular Atrophy
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Frailty
- Muscle Weakness
- Atrophy
- Sarcopenia
- Asthenia
- Investigative Techniques
- Methods
- Observation
Other Study ID Numbers
- 1117
- 367102 (Other Identifier: IRAS)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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