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NCT Number: NCT06829004

Calf Circumference Adjusted for Body Composition to Assess Muscle Mass

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.

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Key information

Conditions

Muscle Mass Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity and Overweight Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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)

  4. Bone density estimated from corrected calf circumference

    Time frame: 15 months

    Bone density may be possible to estimate from corrected calf circumference

Study contacts

Contact information is provided by the study sponsor or research team.

Alastair Forbes, MD

CONTACT

[email protected]

+37258830422

Grete Kurik, MSc

CONTACT

[email protected]

+37253436535

Sponsors and collaborators

Lead sponsor

University of Tartu

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Feb 17, 2025
Registry last updated
Feb 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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