Muscle Ultrasound for Sarcopenia Leading to Early Detection

NCT02319850 | Completed

• 2 other identifiers: 081320UL1TR000075
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Sarcopenia

Keywords

sarcopenia; screening; geriatrics; muscle; aging; ultrasound

Outcome Measures

Primary Outcomes (1)

• 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.

  1 day

Secondary Outcomes (4)

• DXA lean body mass

  1 day

• Grip strength

  1 day

• Lower extremity function

  1 day

• Physical activity questionnaire

  1 day

Study Arms (2)

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

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

Interventions

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).

Also known as: Radiograph, x-rays

Comparison Group; Reference Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify 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).

You may not qualify 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.

Sponsors & Collaborators

• George Washington University: lead
• National Institutes of Health (NIH): collaborator
• Children's National Research Institute: collaborator

Study Sites (1)

George Washington University

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

Location

Related Publications (1)

• 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.

  PMID: 25071570 BACKGROUND

MeSH Terms

Conditions

Sarcopenia

Interventions

X-Rays

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing

Study Officials

• Loretta DiPietro, PhD, MPH

  George Washington University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2014
• First Posted: December 18, 2014
• Study Start: February 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: March 1, 2018

Record last verified: 2018-02

Locations

US (1)