Using Bedside Ultrasound to Screen for Sarcopenia in Older Adults

Sarcopenia Clinical Trial

Official title:

Using Bedside Ultrasound to Screen for Sarcopenia in Older Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04370912
• Other study ID #: H20-01355
• Status: Completed
• 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
• 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
• 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

Related Conditions & MeSH terms

• Sarcopenia

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