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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04370912
Other study ID # H20-01355
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 1, 2021
Est. completion date April 1, 2022

Study information

Verified date October 2022
Source University of British Columbia
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

Some recent work has examined the possibility of using ultrasound as a measure of both muscle quantity and muscle quantity. Work done by Strasser et al, has shown that ultrasonic measures of muscle thickness in the quadriceps muscle has a highly significant correlation with maximal voluntary contration. Other work done by Miron-Mombiela et al has shown that measures of muscle thickness and echointensity (a measure of muscle quality) also show high correlations with grip strength. These findings (supported by our pilot data, see Pilot Data) and new technological advances in bedside ultrasonic devices suggest that these measures might be a valuable contribution to the process of screening for sarcopenia in older adults. In this proposal, Investigators hypothesize that bedside ultrasound, which is increasingly becoming a mainstream component of the standard physical exam, will be a much more specific and accurate alternative to our current best screening methods.


Recruitment information / eligibility

Status Completed
Enrollment 152
Est. completion date April 1, 2022
Est. primary completion date December 31, 2021
Accepts healthy volunteers
Gender All
Age group 65 Years and older
Eligibility Inclusion Criteria: - each subject must be 65 years of age or greater Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Bed side Ultrasound
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

Locations

Country Name City State
Canada Vancouver Coastal Health Research Institute, VGH Research Pavilion Room 186 Vancouver British Columbia

Sponsors (2)

Lead Sponsor Collaborator
University of British Columbia Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary Weight in kg weight and height will be combined to report BMI in kg/m^2 through study completion, an average of 1 year
Primary Height in cm weight and height will be combined to report BMI in kg/m^2 through study completion, an average of 1 year
Primary Handgrip strength in kg Handgrip strength cutoffs for sarcopenia for men and women through study completion, an average of 1 year
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