- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06829004
Calf Circumference Adjusted for Body Composition to Assess Muscle Mass
Study Overview
Status
Conditions
Detailed Description
The patient's demographic data including age, sex, primary diagnosis, and diagnoses of co-morbidities are found by the investigator in the medical history (eHL). The researcher codes the current main diagnosis and its severity: we use the World Health Organization's ICD-11 classification (icd.who.int/browse11/l-m/en) and a three-point scale where 1 is mild and 3 is severe.
The patient will be interviewed for changes in body weight and food intake. Anthropometric measurements will be recorded, including height, weight, body mass index (BMI), mid upper arm circumference, calf circumference, and waist circumference.
The accurate muscle mass measurement will be done using total body densitometry (DEXA) scan, that was already ordered for other purposes. Bone mineral density (BMD) from DEXA scan will be recorded. This allows us to see if calf circumference can be used for estimating bone mineral density. Patients will be followed up one year after data collection. Follow up will involve calling the patients and asking them questions from the SarQoL (sarcopenia quality of life questionnaire)
Calf circumference will be measured using non-elastic tape at the widest part of the dominant calf in the seated position with the weight evenly distributed on both feet (1). Mid upper arm circumference will be measured at the midpoint between the acromial surface of the scapula and the olecranon process of the elbow over the dominant arm when bent at 90 degrees. Waist circumference will be measured using measuring tape 2.5 cm above the umbilicus in a standing position. Waist circumference is used to define obesity as it is a marker of abdominal obesity (2). We aim to keep the interview no longer than 10 minutes.
Demographic and anthropometric data will be analyzed using descriptive statistics. The sensitivity, specificity of muscle mass measurements will be calculated. Corrected calf circumference will be compared to DEXA (gold standard diagnostic tool) and new cutoffs will be defined by using Receiver Operating Characteristic curves. Statistical analyses will be performed using R.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Grete Kurik, MSc
- Phone Number: +37253436535
- Email: grete.kurik@ut.ee
Study Contact Backup
- Name: Alastair Forbes, MD
- Phone Number: +37258830422
- Email: alastair.forbes@ut.ee
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
Booked to undergo bone density scanning (DEXA) at Tartu University Hospital
Exclusion Criteria:
Isolation for infectious disease Pregnancy and lactation Unable to understand or follow study protocol
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
Patients undergoing bone density scanning at Tartu University Hospital
Patients undergoing bone density scanning at Tartu University Hospital selected from those attending the internal medicine clinics
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Accuracy of corrected calf circumference in estimating muscle mass
Time Frame: 15 months
|
Accuracy of corrected calf circumference in estimating muscle mass in comparison to densitometry (DEXA) used as a gold standard
|
15 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Comparison of accuracy of corrected calf measurement results in female patients
Time Frame: 15 months
|
Comparison of accuracy of results in female patients thought to be in greater need of correction
|
15 months
|
|
Comparison of accuracy of corrected calf measurement results in obese patients
Time Frame: 15 months
|
Calf measurement results thought to be less reliable in obese patients
|
15 months
|
|
Quality of life with and without corrected results of anthropometry
Time Frame: 15 months
|
Low muscle mass is associated with poor quality of life and may be estimated better with anthropometric corrections.
Quality of life will be measured using the SarQoL tool designed to examine quality of life in sarcopenia (0-100 scale high being good)
|
15 months
|
|
Bone density estimated from corrected calf circumference
Time Frame: 15 months
|
Bone density may be possible to estimate from corrected calf circumference
|
15 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Alastair Forbes, MD, University of Tartu
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 396/T-16
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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