Muscle AtrophyNCT05729880
Can Ultrasound be Used as a Measure of Muscle Quality? A Validation Study Comparing Ultrasound With MRI and MRS in Older and Younger Persons.
An observational study of Muscle Atrophy, run by University of Exeter at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Muscle Atrophy
- What is being tested?
- MRI, MRS and Ultrasound
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 10 Jun 2022to 1 Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: General population
Who may be able to join
- Age <40y or >50yrs
Who cannot join
- Significant cognitive deficits and the inability to follow directions during assessment.
- Neurological, neuromuscular, or musculoskeletal disorders that could impair the quality of the muscle. eg. CP, muscular dystrophy or SCI
- Prosthesis with metalwork, eg. metal work from surgery
- Aneurysm clip in situ
- No metal work anywhere, history of metal fragments in eyes, spinal cord or brain.
- Previous exposure to metal flakes and metallic injury.
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- No external implants; cochlear implant, spinal cord simulator, pacemaker or other implanted electronic devices.
- Non-removal hearing aids
- FEMALE ONLY Not pregnant
- Not claustrophobic
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Muscle Atrophy
- Being tested
- MRI, MRS, Ultrasound
- Keywords
- ultrasound, mri
- Medical subject headings
- Muscular Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI, MRSDiagnostic test
Scan of right calf and thigh
UltrasoundDiagnostic test
Scan of right calf and thigh
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: MRI, MRS; Diagnostic Test: Ultrasound | |
| 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. Receives: Diagnostic Test: MRI, MRS; Diagnostic Test: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 1 year
Fat fraction
Obtained from MRI and will be used to validate the ultrasound echogenecity
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2023
- Study start10 Jun 2022
- Primary completion16 Nov 2022
- Study completion1 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle AtrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Exeter
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francis Stephens, Principal investigator, University of Exeter
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05729880
- Sponsor's protocol ID
- 2021-22-44
- Status last verified
- May 2024
- First submitted
- 16 Jan 2023
- Last updated
- 9 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Participant data will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05729880
- Acronym / sponsor ID
- 2021-22-44
- Conditions
- Muscle Atrophy
- Keywords
- ultrasound, mri
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of ExeterUniversity, hospital or other
- Study start
- 10 Jun 2022 (actual)
- Primary completion
- 16 Nov 2022 (actual)
- Study completion
- 1 Apr 2023 (actual)
- First posted
- 15 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Older | – | Diagnostic Test: MRI, MRS, Diagnostic Test: Ultrasound16 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. |
| Young | – | Diagnostic Test: MRI, MRS, Diagnostic Test: Ultrasound16 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- General population
Key inclusion criteria (1 listed)
- Age <40y or >50yrs
Key exclusion criteria (10 listed)
- Significant cognitive deficits and the inability to follow directions during assessment.
- Neurological, neuromuscular, or musculoskeletal disorders that could impair the quality of the muscle. eg. CP, muscular dystrophy or SCI
- Prosthesis with metalwork, eg. metal work from surgery
- Aneurysm clip in situ
- No metal work anywhere, history of metal fragments in eyes, spinal cord or brain.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI, MRSScan of right calf and thigh | Diagnostic test | Older, Young |
| UltrasoundScan of right calf and thigh | Diagnostic test | Older, Young |
Primary outcome
Ultrasound muscle thickness (cm)
Time frame: 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
Ultrasound echogenecity (arbitrary units on histogram)
Time frame: 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
Fat fraction
Time frame: 1 year
Obtained from MRI and will be used to validate the ultrasound echogenecity
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2024.
- Individual participant dataSharing planned: No. Participant data will not be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francis Stephens principal investigator
University of Exeter
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Muscle Atrophy, run by University of Exeter at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ultrasound muscle thickness (cm) (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2024; AzTrials last refreshed its copy on 8 Nov 2026.