Calf Circumference Adjusted for Body Composition to Assess Muscle Mass
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Muscle Mass, Obesity and Overweight. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
Muscle mass is a critical indicator for malnutrition and sarcopenia assessment. Anthropometric measurements like calf circumference (CC) could be a simple and cost-effective alternative when gold standard methods are not available. However, CC is probably less accurate for estimating muscle mass in female patients and patients with obesity. This study investigates whether adjusting CC using mid-upper arm circumference (MUAC) improves muscle mass estimation in patients with obesity. If validated, this correction method would serve as a simple clinical tool for muscle mass assessment.
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.
Primary outcome measures
- Accuracy of corrected calf circumference in estimating muscle mass [Time frame: 15 months]
Secondary outcome measures (4)
- Comparison of accuracy of corrected calf measurement results in female patients [Time frame: 15 months]
- Comparison of accuracy of corrected calf measurement results in obese patients [Time frame: 15 months]
- Quality of life with and without corrected results of anthropometry [Time frame: 15 months]
- Bone density estimated from corrected calf circumference [Time frame: 15 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- Deutz NEP, Ashurst I, Ballesteros MD, Bear DE, Cruz-Jentoft AJ, Genton L, Landi F, Laviano A, Norman K, Prado CM. The Underappreciated Role of Low Muscle Mass in the Management of Malnutrition. J Am Med Dir Assoc. 2019 Jan;20(1):22-27. doi: 10.1016/j.jamda.2018.11.021. PMID 30580819
Identifiers
NCT: NCT06829004 · 396/T-16