Can Ultrasound be Used as a Measure of Muscle Quality? A Validation Study Comparing Ultrasound With MRI and MRS in Older and Younger Persons.

This study aims to see if ultrasound can be used as a reliable and valid method to measure fatty infiltration, muscle thickness and muscle architecture to provide a quick, cheap and mobile alternative measure of muscle quality to MRI.

The MRS and MRI images will be used to validate the ultrasound images.

Study Overview

• Status: Completed
• Conditions: Muscle Atrophy
• Intervention / Treatment: Diagnostic test: MRI, MRS; Diagnostic test: Ultrasound

Detailed Description

A key hallmark of the natural biology of ageing is a progressive loss of skeletal muscle mass, strength and aerobic capacity, termed 'sarcopenia' (Cruz-Jentoft et al. 2019a). The association between muscle loss (mass and quality) and increased incidence of falls, fractures, metabolic disease and other health complications is well established. Despite exercise and physiotherapy, recovery from these is often incomplete and studies have failed to identify fully effective countermeasures (Reeves et al, 2005). Ways to objectively measure the clinical effectiveness of the countermeasures are also limited.

Muscle quality can be measured in terms of muscle thickness, architecture (pennation angle and fascicle length) and fatty infiltration. At present ultrasound muscle thickness and architecture have been shown against MRI to be a reliable and valid but fatty infiltration can only be measured reliably using MRI. MRI is an expensive, time consuming and immobile technique limiting its use as a clinical tool in a rehabilitative setting. Finding a cheaper, quicker and mobile alternative, such as ultrasound, would enable clinicians to gather useful information on patient muscle quality in an objective manner and use this information to tailor treatment accordingly.

15 old (>50y) and 15 young (<40y) will be recruited. MRI, MRS and Ultrasound will be measured in each participant in calf and thigh muscle, at the same location within a 1 hour time frame.

MRI and MRS will provide the validation to ultrasound fatty infiltration.

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• United Kingdom
  • Devon
    • Exeter, Devon, United Kingdom, EX2 4TH
      • University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

General population

Description

Inclusion Criteria:

- Age <40y or >50yrs

Exclusion Criteria:

1. Significant cognitive deficits and the inability to follow directions during assessment.
2. Neurological, neuromuscular, or musculoskeletal disorders that could impair the quality of the muscle. eg. CP, muscular dystrophy or SCI
3. Prosthesis with metalwork, eg. metal work from surgery
4. Aneurysm clip in situ
5. No metal work anywhere, history of metal fragments in eyes, spinal cord or brain.
6. Previous exposure to metal flakes and metallic injury.
7. No external implants; cochlear implant, spinal cord simulator, pacemaker or other implanted electronic devices.
8. Non-removal hearing aids
9. FEMALE ONLY Not pregnant
10. Not claustrophobic

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Older; 16 older (>50y) will be recruited. MRI, MRS and Ultrasound will be measured in each participant in calf and thigh muscle, at the same location within a 1 hour time frame.	Diagnostic test: MRI, MRS; Scan of right calf and thigh; Diagnostic test: Ultrasound; Scan of right calf and thigh
Young; 16 young (<40y) will be recruited. MRI, MRS and Ultrasound will be measured in each participant in calf and thigh muscle, at the same location within a 1 hour time frame.	Diagnostic test: MRI, MRS; Scan of right calf and thigh; Diagnostic test: Ultrasound; Scan of right calf and thigh

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ultrasound muscle thickness (cm)	A single ultrasound image can measure both thickness (cm) and echogenecity (AU). Echogenecity has been used as a proxy for fat infiltration. By combining both thickness and fat infiltration and index of muscle quality can be determined	1 year
Ultrasound echogenecity (arbitrary units on histogram)	A single ultrasound image can measure both thickness (cm) and echogenecity (AU). Echogenecity has been used as a proxy for fat infiltration. By combining both thickness and fat infiltration and index of muscle quality can be determined	1 year
Fat fraction	Obtained from MRI and will be used to validate the ultrasound echogenecity	1 year

Collaborators and Investigators

• Sponsor: University of Exeter
• Investigators: Principal Investigator: Francis Stephens, University of Exeter

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2022
• Primary Completion (Actual): November 16, 2022
• Study Completion (Actual): April 1, 2023

Study Registration Dates

• First Submitted: January 16, 2023
• First Submitted That Met QC Criteria: February 6, 2023
• First Posted (Actual): February 15, 2023

Study Record Updates

• Last Update Posted (Actual): May 9, 2024
• Last Update Submitted That Met QC Criteria: May 8, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: ultrasound; mri
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Atrophy; Muscular Atrophy
• Other Study ID Numbers: 2021-22-44

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Participant data will not be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No