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Completed

NCT Number: NCT02319850

Muscle Ultrasound for Sarcopenia Leading to Early Detection

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.

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Key information

Conditions

Sarcopenia Atrophy Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

George Washington University

Washington D.C., District of Columbia, 20052, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

You are eligible to participate if:

  • 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).

Exclusion criteria

You are not eligible to participate if:

  • 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.

Treatment and study plan

DXA scanning

Radiation

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

George Washington University

Other

Collaborators

  • Children's National Research Institute
  • National Institutes of Health (NIH)

Registry information

Official study title

Revisiting the Sarcopenia Diagnosis: New Approaches to Rapid Screening and Preventative Healthcare

Acronym: MUSCLED

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Dec 18, 2014
Registry last updated
Mar 1, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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