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

Sponsor
University of Exeter (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05729880
Collaborator
(none)
30
1
17.7
1.7

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Actual Enrollment :
30 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
Can Ultrasound be Used as a Measure of Muscle Quality? A Validation Study Comparing Ultrasound With MRI and MRS in Older and Younger Persons.
Actual Study Start Date :
Jun 10, 2022
Actual Primary Completion Date :
Nov 16, 2022
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Ultrasound muscle thickness (cm) [1 year]

    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

  2. Ultrasound echogenecity (arbitrary units on histogram) [1 year]

    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

  3. Fat fraction [1 year]

    Obtained from MRI and will be used to validate the ultrasound echogenecity

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Exeter Devon United Kingdom EX2 4TH

Sponsors and Collaborators

  • University of Exeter

Investigators

  • Principal Investigator: Francis Stephens, University of Exeter

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Exeter
ClinicalTrials.gov Identifier:
NCT05729880
Other Study ID Numbers:
  • 2021-22-44
First Posted:
Feb 15, 2023
Last Update Posted:
Feb 15, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of Exeter
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 15, 2023