Calf Circumference Adjusted for Body Composition to Assess Muscle Mass

NCT ID: NCT06829004

Last Updated: 2025-02-17

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-02-15
• Study Completion Date: 2026-06-30

Brief Summary

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.

Conditions

Muscle Mass; Obesity and Overweight

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Tartu

OTHER

Sponsor Role: lead

Responsible Party

Alastair Forbes

Visiting Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alastair Forbes, MD

Role: STUDY_DIRECTOR

University of Tartu

Central Contacts

Grete Kurik, MSc

Role: CONTACT

grete.kurik@ut.ee

+37253436535

Alastair Forbes, MD

Role: CONTACT

alastair.forbes@ut.ee

+37258830422

References

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.

Reference Type: BACKGROUND

PMID: 30580819 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

396/T-16

Identifier Type: -

Identifier Source: org_study_id