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Muscle Ultrasound for Sarcopenia Leading to Early Detection (MUSCLED)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02319850
Recruitment Status : Completed
First Posted : December 18, 2014
Last Update Posted : March 1, 2018
Sponsor:
Collaborators:
National Institutes of Health (NIH)
Children's National Research Institute
Information provided by (Responsible Party):
George Washington University

Brief 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. 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.


Condition or disease Intervention/treatment
Sarcopenia Radiation: DXA scanning

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.

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Study Type : Observational
Actual Enrollment : 34 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Revisiting the Sarcopenia Diagnosis: New Approaches to Rapid Screening and Preventative Healthcare
Study Start Date : February 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Group/Cohort Intervention/treatment
Reference Group
18 - 29 years of age; apparently healthy younger participants; 1:1 male and female recruitment ratio (Exposure include DXA scanning).
Radiation: DXA scanning
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).
Other Name: Radiograph, x-rays

Comparison Group
55 - 75 years of age; apparently healthy older participants; 1:1 male and female recruitment ratio (Exposure include DXA scanning).
Radiation: DXA scanning
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).
Other Name: Radiograph, x-rays




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. DXA lean body mass [ Time Frame: 1 day ]
    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%).

  2. Grip strength [ Time Frame: 1 day ]
    Grip strength will be assessed bilaterally using a isometric dynamometer.

  3. Lower extremity function [ Time Frame: 1 day ]
    A standardized timed sit-to-stand test will be conducted (5 repetitions).

  4. Physical activity questionnaire [ Time Frame: 1 day ]
    Participants will also complete the International Physical Activity Questionnaire (IPAQ) to obtain an estimate of their customary activity and formal exercise.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria: You are eligible to participate if:

  1. You are between the ages of 18 - 29 years, or 55 - 75 years.
  2. You must be able to stand comfortably for 10 minutes and walk a short distance (use of assistive devices are acceptable).

Exclusion Criteria: You are not eligible to participate if:

  1. You have a medical condition that results in edema.
  2. You have had an upper or a lower extremity amputation.
  3. You are, or may be, pregnant.
  4. You have a body mass index (BMI) > 30.0.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02319850


Locations
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United States, District of Columbia
George Washington University
Washington, District of Columbia, United States, 20052
Sponsors and Collaborators
George Washington University
National Institutes of Health (NIH)
Children's National Research Institute
Investigators
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Principal Investigator: Loretta DiPietro, PhD, MPH George Washington University
Publications:
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Responsible Party: George Washington University
ClinicalTrials.gov Identifier: NCT02319850    
Other Study ID Numbers: 081320
UL1TR000075 ( U.S. NIH Grant/Contract )
First Posted: December 18, 2014    Key Record Dates
Last Update Posted: March 1, 2018
Last Verified: February 2018
Keywords provided by George Washington University:
sarcopenia
screening
geriatrics
muscle
aging
ultrasound
Additional relevant MeSH terms:
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Sarcopenia
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical