- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04370912
Using Bedside Ultrasound to Screen for Sarcopenia in Older Adults
October 31, 2022 updated by: Kenneth Madden, University of British Columbia
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Observational
Enrollment (Actual)
152
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
British Columbia
-
Vancouver, British Columbia, Canada, V5Z 1M9
- Vancouver Coastal Health Research Institute, VGH Research Pavilion Room 186
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years and older (Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-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.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
US measurement for Sarcopenia
Time Frame: through study completion, an average of 1 year
|
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
Time Frame: through study completion, an average of 1 year
|
weight and height will be combined to report BMI in kg/m^2
|
through study completion, an average of 1 year
|
Height in cm
Time Frame: through study completion, an average of 1 year
|
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
Time Frame: through study completion, an average of 1 year
|
Handgrip strength cutoffs for sarcopenia for men and women
|
through study completion, an average of 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2021
Primary Completion (Actual)
December 31, 2021
Study Completion (Actual)
April 1, 2022
Study Registration Dates
First Submitted
April 27, 2020
First Submitted That Met QC Criteria
April 29, 2020
First Posted (Actual)
May 1, 2020
Study Record Updates
Last Update Posted (Actual)
November 2, 2022
Last Update Submitted That Met QC Criteria
October 31, 2022
Last Verified
October 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H20-01355
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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