NCT04370912

Brief Summary

The loss of both muscle mass and quality with increasing age is called 'sarcopenia' and is a risk factor for falls, fractures and increased mortality. Sarcopenia is diagnosed with Dual-energy X-ray absorptiometry (DXA) scanning (according to current criteria), but in Canada DXA scans are not approved to screen for this condition. One potential solution is Point of Care Ultrasound (PoCUS), since recent advances have made bedside ultrasound technology readily available as a rapid bedside screening tool.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
152

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

April 27, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 1, 2020

Completed
1.3 years until next milestone

Study Start

First participant enrolled

September 1, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
Last Updated

November 2, 2022

Status Verified

October 1, 2022

Enrollment Period

4 months

First QC Date

April 27, 2020

Last Update Submit

October 31, 2022

Conditions

Outcome Measures

Primary Outcomes (4)

  • US measurement for Sarcopenia

    o establish PoCUS measures (muscle thickness, MT; echointensity, EI) as a new screening test for sarcopenia

    through study completion, an average of 1 year

  • Weight in kg

    weight and height will be combined to report BMI in kg/m\^2

    through study completion, an average of 1 year

  • Height in cm

    weight and height will be combined to report BMI in kg/m\^2

    through study completion, an average of 1 year

  • Handgrip strength in kg

    Handgrip strength cutoffs for sarcopenia for men and women

    through study completion, an average of 1 year

Interventions

Bed side UltrasoundDIAGNOSTIC_TEST

Handgrip strength will be measured using a digital grip strength dynamometer (Sammons Preston, Nottinghamshire, UK). This measurement is carried out three times using the subject's dominant hand, and then averaged

Also known as: Grip strength, Appendicular Skeletal Mass assessment

Eligibility Criteria

Age65 Years+
Sexall
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects will be recruited from Vancouver Coastal Health Authority has 5 outpatient geriatric medicine clinics that continuously for 5 days per week and see 4000 new patients per year.

You may qualify if:

  • each subject must be 65 years of age or greater

You may not qualify if:

  • hemodialysis patients will be excluded, due to excessive fluid shifts with dialysis
  • patients using chronic oral corticosteroids will be excluded, due to potential muscle atrophy
  • hemiparesis due to a stroke or paresis of the lower limbs will be excluded
  • subjects with pitting edema on physical exam (due to liver, renal or heart failure) or patients that are severely dehydrated will be excluded
  • patients with myositis, systemic connective tissue disorders, systemic atrophies affecting the central nervous system (CNS) and CNS demyelinating diseases will be excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vancouver Coastal Health Research Institute, VGH Research Pavilion Room 186

Vancouver, British Columbia, V5Z 1M9, Canada

Location

MeSH Terms

Conditions

Sarcopenia

Interventions

Hand Strength

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Muscle StrengthPhysical ExaminationDiagnostic Techniques and ProceduresDiagnosisMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Kenneth Madden, MD

    UBC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Allan M. McGavin Chair in Geriatric Medicine Division Head, Vancouver General Hospital Division of Geriatric Medicine

Study Record Dates

First Submitted

April 27, 2020

First Posted

May 1, 2020

Study Start

September 1, 2021

Primary Completion

December 31, 2021

Study Completion

April 1, 2022

Last Updated

November 2, 2022

Record last verified: 2022-10

Locations