University of Leicester
Leicester, LE1 7RH, United Kingdom
Location contact
Matt Harrison, BSc MA
CONTACT
Matt Harrison, BSc MA
SUB_INVESTIGATOR
Seth O'Neill, PhD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07726498
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 opening soon.
Get Notified18 year and older
All sexes
Observational
Leicester, LE1 7RH, United Kingdom
Matt Harrison, BSc MA
CONTACT
Matt Harrison, BSc MA
SUB_INVESTIGATOR
Seth O'Neill, PhD
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
No intervention (observational study)
Time frame: Baseline
Isometric plantarflexor strength will be tested using the Fysiometer C-station
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.
Time frame: Baseline
Imaging of the Achilles Tendon to identify structural changes to the Achilles tendon.
Time frame: Baseline
Imaging of the Plantarflexors and Achilles Tendon to understand muscle stiffness and tissue mechanical properties
Time frame: Baseline
A Jamar hand dynamometer will be used, measuring grip strength in kilograms
Time frame: Baseline
Isometric Knee Extension strength will be measured using Kinvent K-Pull incline dynamometer
Time frame: Baseline
Bioelectrical impedance analysis (BIA) will be used to estimate body composition and Skeletal Muscle Mass.
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.
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.
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.
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.
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).
University of Leicester
Other
Acronym: STRIDE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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