Clinical trial NCT02319850: Muscle Ultrasound for Sarcopenia Leading to Early Detection
Official title: Revisiting the Sarcopenia Diagnosis: New Approaches to Rapid Screening and Preventative Healthcare
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sarcopenia
Keywords: sarcopenia
screening
geriatrics
muscle
aging
ultrasound
Lead sponsor: George Washington University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: Children's National Research Institute
First posted: 2014-12-18
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.

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.

Eligibility 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.

Primary outcomes:
measure: Sonographic Lean Body Mass
timeFrame: 1 day
Secondary outcomes:
measure: DXA lean body mass
timeFrame: 1 day
measure: Grip strength
timeFrame: 1 day
measure: Lower extremity function
timeFrame: 1 day
measure: Physical activity questionnaire
timeFrame: 1 day
Other outcomes:
Locations:
city: Washington
country: United States
facility: George Washington University
state: District of Columbia
Study officials:
affiliation: George Washington University
name: Loretta DiPietro, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.