MUSCLED: Muscle Ultrasound for Sarcopenia Leading to Early Detection

Sponsor
George Washington University (Other)
Overall Status
Completed
CT.gov ID
NCT02319850
Collaborator
National Institutes of Health (NIH) (NIH), Children's National Research Institute (Other)
34
1
21.9
1.5

Study Details

Study Description

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 Phase
  • 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.

Study Design

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 :
Feb 1, 2014
Actual Primary Completion Date :
Dec 1, 2015
Actual Study Completion Date :
Dec 1, 2015

Arms and Interventions

Arm 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 Names:
  • 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 Names:
  • Radiograph, x-rays
  • Outcome Measures

    Primary Outcome Measures

    1. Sonographic Lean Body Mass [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 [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 [1 day]

      Grip strength will be assessed bilaterally using a isometric dynamometer.

    3. Lower extremity function [1 day]

      A standardized timed sit-to-stand test will be conducted (5 repetitions).

    4. Physical activity questionnaire [1 day]

      Participants will also complete the International Physical Activity Questionnaire (IPAQ) to obtain an estimate of their customary activity and formal exercise.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 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

    • Principal Investigator: Loretta DiPietro, PhD, MPH, George Washington University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    George Washington University
    ClinicalTrials.gov Identifier:
    NCT02319850
    Other Study ID Numbers:
    • 081320
    • UL1TR000075
    First Posted:
    Dec 18, 2014
    Last Update Posted:
    Mar 1, 2018
    Last Verified:
    Feb 1, 2018
    Keywords provided by George Washington University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 1, 2018