NCT02920619

Brief Summary

The purpose of this study is to develop computational methods for cross-comparison of muscle composition measurements in three laboratory ultrasound systems.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

September 24, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 30, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

May 17, 2018

Status Verified

May 1, 2018

Enrollment Period

2 years

First QC Date

September 24, 2016

Last Update Submit

May 16, 2018

Conditions

Keywords

ultrasoundmuscle

Outcome Measures

Primary Outcomes (1)

  • Echogenicity

    Echogenicity values (i.e., image brightness) obtained from the ultrasound scans (units: grayscale levels, 0-255)

    1 day

Secondary Outcomes (1)

  • Muscle thickness

    1 day

Interventions

Imaging of the rectus femoris, lower-trapezius, brachioradialis, tibialis anterior, middle deltoid, and pectoralis major will be conducted in Veteran participants during a single visit to the Washington D.C. Veterans Affairs Medical Center. Imaging will be conducted by investigators experienced with quantitative ultrasound using diagnostic musculoskeletal B-mode ultrasound with a 10 Mhz linear transducer.

Eligibility Criteria

Age20 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Thirty adult Veterans (20-85 years) will be recruited for the study from the DC VAMC.

You may qualify if:

  • Male or female Veteran who receives medical care at the Washington DC VA Medical Center
  • Ages 20-85

You may not qualify if:

  • Limb amputation (upper or lower extremity)
  • Lower extremity joint replacement
  • Severe cognitive impairment
  • Edema
  • Inability to read, speak, or understand English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington DC VA Medical Center

Washington D.C., District of Columbia, 20422, United States

Location

Related Publications (1)

  • Harris-Love MO, Seamon BA, Teixeira C, Ismail C. Ultrasound estimates of muscle quality in older adults: reliability and comparison of Photoshop and ImageJ for the grayscale analysis of muscle echogenicity. PeerJ. 2016 Feb 22;4:e1721. doi: 10.7717/peerj.1721. eCollection 2016.

    PMID: 26925339BACKGROUND

MeSH Terms

Interventions

Ultrasonography

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Michael Harris-Love, D.Sc.

    Washington DC VA Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Director, CRC Human Performance Research Unit

Study Record Dates

First Submitted

September 24, 2016

First Posted

September 30, 2016

Study Start

September 1, 2016

Primary Completion

September 1, 2018

Study Completion

December 1, 2018

Last Updated

May 17, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations