SarcopeniaMUSCLEDNCT02319850
Muscle Ultrasound for Sarcopenia Leading to Early Detection
An observational study of Sarcopenia, run by George Washington University at 1 site in United States.
Trial summary
Sarcopenia is an age-related loss of muscle mass that may affect over 25% of individuals over the age of 60 and results in a 3 to 4 times increased likelihood of developing a disability. Despite these observations, sarcopenia is rarely subject to a systematic screening process as a part of customary geriatric care. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia
- What is being tested?
- DXA scanning
- Type of treatment
- Surgery or procedure
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to Dec 2015
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Enrolled subjects in this pilot study will include a healthy young reference group (18 - 29 years of age) and an older comparison group (55 - 75 years of age; n = 15 per group; approximately 50% female), consecutively recruited from George Washington University and the surrounding community.
Who may be able to join
- You are between the ages of 18 - 29 years, or 55 - 75 years.
- You must be able to stand comfortably for 10 minutes and walk a short distance (use of assistive devices are acceptable).
Who cannot join
- You have a medical condition that results in edema.
- You have had an upper or a lower extremity amputation.
- You are, or may be, pregnant.
- You have a body mass index (BMI) > 30.0.
Trial locations and contacts
1 site in 1 country.
United States1 site
George Washington University
Washington D.C., District of Columbia, 20052
About this study
Official title: Revisiting the Sarcopenia Diagnosis: New Approaches to Rapid Screening and Preventative Healthcare
Sarcopenia is an age-related loss of muscle mass that may affect over 25% of individuals over the age of 60 and results in a 3 to 4 times increased likelihood of developing a disability. Despite these observations, sarcopenia is rarely subject to a systematic screening process as a part of customary geriatric care. Furthermore, when lean body mass (LBM) is measured via dual energy X-ray absorptiometry (DXA) in older adults, it is typically within a reactive, hospital-based, model of healthcare where muscle wasting is only assessed after a loss of functional independence. The investigators propose an affordable, portable screening method with ultrasound imaging to be performed in primary care settings.
The investigators long term goal is to identify individuals at risk, and intervene with treatments that may prevent the onset of debilitating loss of muscle function in the elderly.
Read the detailed description
Purpose: The overall goal of this pilot project is to validate a rapid, portable, cost-effective, sarcopenia identification method using diagnostic sonography. This method would be used for screening to aid early detection, diagnosis in clinical settings, and monitoring the effects of formal intervention. The investigators central hypothesis is that the sonographic muscle characteristics will be significantly associated with estimates of lean body mass (LBM) and functional status.
Research Setting: George Washington University, Exercise Science Laboratory.
Participants: Subjects will include a healthy young reference group (18 - 29 years of age) and an older comparison group (55 - 75 years of age; n = 15 per group; approximately 50% female), consecutively recruited from George Washington University and the surrounding community.
Implications/Significance: Diagnostic musculoskeletal ultrasound is a portable, inexpensive modality suitable for bedside use or community health initiatives, and features no exposure to low-dose radiation. It is important to note that DXA is considered a relatively low cost procedure, and DXA-based measures may continue to be used as the standard for the sarcopenia syndrome LBM criterion. Consequently, this study will examine if LBM values obtained with ultrasound may serve as a viable proxy of LBM measures obtained with DXA.
The innovation in the investigators study is reflected by a proactive approach to sarcopenia screening that is responsive to the growing shift of healthcare from hospitals to alternative, community-based settings.
- Conditions
- Sarcopenia
- Being tested
- DXA scanning
- Keywords
- sarcopenia, screening, geriatrics, muscle, aging, ultrasound
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DXA scanningRadiation
Also called Radiograph, x-rays
Exposure: Participants will undergo DXA scanning in the supine position per manufacturer guidelines to estimate absolute and percentage of total lean body mass (LBM) and body fat (BF).
| Study group | Role | What they receive |
|---|---|---|
| Reference Group | 18 - 29 years of age; apparently healthy younger participants; 1:1 male and female recruitment ratio (Exposure include DXA scanning). Receives: Radiation: DXA scanning | |
| Comparison Group | 55 - 75 years of age; apparently healthy older participants; 1:1 male and female recruitment ratio (Exposure include DXA scanning). Receives: Radiation: DXA scanning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sonographic Lean Body Mass
US estimates of aggregate regional LBM (muscle thickness, cm), will be assessed using B-mode diagnostic US with a 13-6 megahertz linear array transducer for morphology measures at 5 axial and appendicular sites.
Measured: 1 day
Secondary outcomes (4)
DXA lean body mass
Participants will undergo dual energy X-ray absorptiometry (DXA) scanning in the supine position per manufacturer guidelines to estimate absolute and percentage of total LBM, and body fat percentage (BF%).
Measured: 1 day
Grip strength
Grip strength will be assessed bilaterally using a isometric dynamometer.
Measured: 1 day
Lower extremity function
A standardized timed sit-to-stand test will be conducted (5 repetitions).
Measured: 1 day
Physical activity questionnaire
Participants will also complete the International Physical Activity Questionnaire (IPAQ) to obtain an estimate of their customary activity and formal exercise.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2014 (estimated)
- Study startFeb 2014
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- More trials run by George Washington UniversityThe sponsor's other registered studies.
- 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
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- George Washington University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), Children's National Research Institute
- Responsible party
- Sponsor
- Investigators
- Loretta DiPietro, PhD, MPH, Principal investigator, George Washington University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02319850
- Sponsor's protocol ID
- 081320
- Other IDs
- UL1TR000075
- Acronym
- MUSCLED
- Status last verified
- Feb 2018
- First submitted
- 15 Dec 2014
- Last updated
- 1 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Harris-Love MO, Monfaredi R, Ismail C, Blackman MR, Cleary K. Quantitative ultrasound: measurement considerations for the assessment of muscular dystrophy and sarcopenia. Front Aging Neurosci. 2014 Jul 14;6:172. doi: 10.3389/fnagi.2014.00172. eCollection 2014. No abstract available.
PubMed 25071570
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Revisiting the Sarcopenia Diagnosis: New Approaches to Rapid Screening and Preventative Healthcare
- ClinicalTrials.gov ID
- NCT02319850
- Acronym / sponsor ID
- MUSCLED / 081320
- Conditions
- Sarcopenia
- Keywords
- sarcopenia, screening, geriatrics, muscle, aging, ultrasound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- George Washington UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), Children's National Research Institute
- Study start
- Feb 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 18 Dec 2014 (estimated)
- 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.
Sarcopenia is an age-related loss of muscle mass that may affect over 25% of individuals over the age of 60 and results in a 3 to 4 times increased likelihood of developing a disability. Despite these observations, sarcopenia is rarely subject to a systematic screening process as a part of customary geriatric care. Furthermore, when lean body mass (LBM) is measured via dual energy X-ray absorptiometry (DXA) in older adults, it is typically within a reactive, hospital-based, model of healthcare where muscle wasting is only assessed after a loss of functional independence. The investigators propose an affordable, portable screening method with ultrasound imaging to be performed in primary care settings.
The investigators long term goal is to identify individuals at risk, and intervene with treatments that may prevent the onset of debilitating loss of muscle function in the elderly.
Detailed description
Purpose: The overall goal of this pilot project is to validate a rapid, portable, cost-effective, sarcopenia identification method using diagnostic sonography. This method would be used for screening to aid early detection, diagnosis in clinical settings, and monitoring the effects of formal intervention. The investigators central hypothesis is that the sonographic muscle characteristics will be significantly associated with estimates of lean body mass (LBM) and functional status.
Research Setting: George Washington University, Exercise Science Laboratory.
Participants: Subjects will include a healthy young reference group (18 - 29 years of age) and an older comparison group (55 - 75 years of age; n = 15 per group; approximately 50% female), consecutively recruited from George Washington University and the surrounding community.
Implications/Significance: Diagnostic musculoskeletal ultrasound is a portable, inexpensive modality suitable for bedside use or community health initiatives, and features no exposure to low-dose radiation. It is important to note that DXA is considered a relatively low cost procedure, and DXA-based measures may continue to be used as the standard for the sarcopenia syndrome LBM criterion. Consequently, this study will examine if LBM values obtained with ultrasound may serve as a viable proxy of LBM measures obtained with DXA.
The innovation in the investigators study is reflected by a proactive approach to sarcopenia screening that is responsive to the growing shift of healthcare from hospitals to alternative, community-based settings.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reference Group | – | Radiation: DXA scanning18 - 29 years of age; apparently healthy younger participants; 1:1 male and female recruitment ratio (Exposure include DXA scanning). |
| Comparison Group | – | Radiation: DXA scanning55 - 75 years of age; apparently healthy older participants; 1:1 male and female recruitment ratio (Exposure include DXA scanning). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Enrolled subjects in this pilot study will include a healthy young reference group (18 - 29 years of age) and an older comparison group (55 - 75 years of age; n = 15 per group; approximately 50% female), consecutively recruited from George Washington University and the surrounding community.
Key inclusion criteria (2 listed)
- You are between the ages of 18 - 29 years, or 55 - 75 years.
- You must be able to stand comfortably for 10 minutes and walk a short distance (use of assistive devices are acceptable).
Key exclusion criteria (4 listed)
- You have a medical condition that results in edema.
- You have had an upper or a lower extremity amputation.
- You are, or may be, pregnant.
- You have a body mass index (BMI) > 30.0.
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 |
|---|---|---|
| DXA scanningAlso: Radiograph, x-raysExposure: Participants will undergo DXA scanning in the supine position per manufacturer guidelines to estimate absolute and percentage of total lean body mass (LBM) and body fat (BF). | Radiation | Comparison Group, Reference Group |
Primary outcome
Sonographic Lean Body Mass
Time frame: 1 day
US estimates of aggregate regional LBM (muscle thickness, cm), will be assessed using B-mode diagnostic US with a 13-6 megahertz linear array transducer for morphology measures at 5 axial and appendicular sites.
4 secondary outcomes
DXA lean body mass
Time frame: 1 day
Grip strength
Time frame: 1 day
Lower extremity function
Time frame: 1 day
Physical activity questionnaire
Time frame: 1 day
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 1 Mar 2018.
- Background: PubMed 25071570Harris-Love MO, Monfaredi R, Ismail C, Blackman MR, Cleary K. Quantitative ultrasound: measurement considerations for the assessment of muscular dystrophy and sarcopenia. Front Aging Neurosci. 2014 Jul 14;6:172. doi: 10.3389/fnagi.2014.00172. eCollection 2014. No abstract available.
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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.
Loretta DiPietro, PhD, MPH principal investigator
George Washington University
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 Sarcopenia, run by George Washington University at 1 site in United States.
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 2 inclusion and 4 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 1 Mar 2018. 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 States. 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?
Sonographic Lean Body Mass (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02319850, which also lists 1 linked publication.
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 1 Mar 2018.