Calf Circumference Versus X-ray Absorptiometry in the Diagnosis of Sarcopenia in Elderly Hospitalized Patients

Sarcopenia Clinical Trial

— PAPY-SARCM  

Official title:

Evaluation of a Diagnostic Method: Calf Circumference Versus X-ray Absorptiometry in the Diagnosis of Sarcopenia in Elderly Hospitalized Participants

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05869487
• Other study ID #: CHRO-2023-02
• Status: Recruiting
• Phase: N/A
• Start date: December 11, 2023
• Est. completion date: April 2025

Study information

• Verified date: January 2024
• Source: Centre Hospitalier Régional d'Orléans
• Contact: ELODIE POUGOUE
• Phone: +33238744086
• Email: elodie.pougoue-touko[@]chr-orleans.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a prospective single-center study to evaluate a diagnostic method. The main objective of the study is to evaluate the performance of calf circumference as a diagnostic method for sarcopenia in hospitalized elderly people, compared to a gold standard method which is X-ray absorptiometry. The study population are hospitalizing participants aged 75 years and older with an indication to search for sarcopenia.

Description:

Sarcopenia is a loss of muscle mass associated with a loss of muscle strength. Sarcopenia is associated with an increase of mortality, risk of falling and hospitalization. The gold standard for assessing loss of muscle mass is X-ray absorptiometry. However, this exam is not systematically performed. The calf circumference (cutoff less than 31 centimeters) is preferentially used. However, this cutoff was defined from a population of women with a mean age of 80 years and a unfrail phenotypic profile that does not allow this result to be applied to elderly hospitalized patients.

The main objective of this study is to evaluate the performance of calf circumference as a diagnostic method for sarcopenia in hospitalized elderly people, compared to a gold standard method which is X-ray absorptiometry.

This is a single-center prospective study to evaluate a diagnostic method. The participants in the study will be hospitalized patients aged 75 years and over, with an indication to search for sarcopenia in the context of screening for protein-energy undernutrition under the recommendations of the French National Authority for Health. Participants will be included after being informed about the protocol and after obtaining their free and informed oral consent. Measurement of calf circumference will be performed before absorptiometry, the results of which will be analyzed in a blinded. The number of subjects to be included with a expected prevalence of 75%, specificity of 95% and an accuracy of 2% is 298 participants according to the literature. A sensitivity and specificity analysis will be performed using the ROC curve. A linear regression analysis will be performed with a significance threshold for the alpha risk of 5%.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 298
• Est. completion date: April 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 75 Years and older

Eligibility

Inclusion Criteria:

• Age greater than or equal to 75 years

• Hospitalization in a medical department or in the follow-up care or rehabilitation department of the Hospital Center of Orléans

• Presence of an etiological criterion of undernutrition

• Presence of a decrease in muscle strength

Exclusion Criteria:

• Presence of one of two phenotypic criteria for undernutrition other than sarcopenia, which are body mass index less than 22 kilogram per square meter and weight loss (= 5 percent over 1 month or = 10 percent over 6 months or =10 percent compared with usual weight before the disease).

• Refusal to participate in the study

• Patient under legal protection

• Impossible to perform X-ray absorptiometry (behavioral problems, functional constraints to climb on the DXA machine)

• Person not affiliated to a social security system

Related Conditions & MeSH terms

• Sarcopenia

Intervention

Radiation:
• Dual-energy X-ray absorptiometry
Whole body x-ray absorptiometry

Locations

Country	Name	City	State
France	CHU d'Orléans	Orléans

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Régional d'Orléans

Country where clinical trial is conducted

France, 

References & Publications (13)

Bahat G, Tufan A, Tufan F, Kilic C, Akpinar TS, Kose M, Erten N, Karan MA, Cruz-Jentoft AJ. Cut-off points to identify sarcopenia according to European Working Group on Sarcopenia in Older People (EWGSOP) definition. Clin Nutr. 2016 Dec;35(6):1557-1563. d — View Citation

Beaudart C, Zaaria M, Pasleau F, Reginster JY, Bruyere O. Health Outcomes of Sarcopenia: A Systematic Review and Meta-Analysis. PLoS One. 2017 Jan 17;12(1):e0169548. doi: 10.1371/journal.pone.0169548. eCollection 2017. — View Citation

Cheng KY, Chow SK, Hung VW, Wong CH, Wong RM, Tsang CS, Kwok T, Cheung WH. Diagnosis of sarcopenia by evaluating skeletal muscle mass by adjusted bioimpedance analysis validated with dual-energy X-ray absorptiometry. J Cachexia Sarcopenia Muscle. 2021 Dec — View Citation

Cruz-Jentoft AJ, Bahat G, Bauer J, Boirie Y, Bruyere O, Cederholm T, Cooper C, Landi F, Rolland Y, Sayer AA, Schneider SM, Sieber CC, Topinkova E, Vandewoude M, Visser M, Zamboni M; Writing Group for the European Working Group on Sarcopenia in Older Peopl — View Citation

Dodds RM, Syddall HE, Cooper R, Benzeval M, Deary IJ, Dennison EM, Der G, Gale CR, Inskip HM, Jagger C, Kirkwood TB, Lawlor DA, Robinson SM, Starr JM, Steptoe A, Tilling K, Kuh D, Cooper C, Sayer AA. Grip strength across the life course: normative data fr — View Citation

Gould H, Brennan SL, Kotowicz MA, Nicholson GC, Pasco JA. Total and appendicular lean mass reference ranges for Australian men and women: the Geelong osteoporosis study. Calcif Tissue Int. 2014 Apr;94(4):363-72. doi: 10.1007/s00223-013-9830-7. Epub 2014 J — View Citation

Kawakami R, Murakami H, Sanada K, Tanaka N, Sawada SS, Tabata I, Higuchi M, Miyachi M. Calf circumference as a surrogate marker of muscle mass for diagnosing sarcopenia in Japanese men and women. Geriatr Gerontol Int. 2015 Aug;15(8):969-76. doi: 10.1111/g — View Citation

Librero J, Peiro S, Ordinana R. Chronic comorbidity and outcomes of hospital care: length of stay, mortality, and readmission at 30 and 365 days. J Clin Epidemiol. 1999 Mar;52(3):171-9. doi: 10.1016/s0895-4356(98)00160-7. — View Citation

Maeda K, Koga T, Nasu T, Takaki M, Akagi J. Predictive Accuracy of Calf Circumference Measurements to Detect Decreased Skeletal Muscle Mass and European Society for Clinical Nutrition and Metabolism-Defined Malnutrition in Hospitalized Older Patients. Ann — View Citation

Pagotto V, Santos KFD, Malaquias SG, Bachion MM, Silveira EA. Calf circumference: clinical validation for evaluation of muscle mass in the elderly. Rev Bras Enferm. 2018 Mar-Apr;71(2):322-328. doi: 10.1590/0034-7167-2017-0121. English, Portuguese. — View Citation

Roberts HC, Denison HJ, Martin HJ, Patel HP, Syddall H, Cooper C, Sayer AA. A review of the measurement of grip strength in clinical and epidemiological studies: towards a standardised approach. Age Ageing. 2011 Jul;40(4):423-9. doi: 10.1093/ageing/afr051 — View Citation

Rolland Y, Lauwers-Cances V, Cournot M, Nourhashemi F, Reynish W, Riviere D, Vellas B, Grandjean H. Sarcopenia, calf circumference, and physical function of elderly women: a cross-sectional study. J Am Geriatr Soc. 2003 Aug;51(8):1120-4. doi: 10.1046/j.15 — View Citation

Studenski SA, Peters KW, Alley DE, Cawthon PM, McLean RR, Harris TB, Ferrucci L, Guralnik JM, Fragala MS, Kenny AM, Kiel DP, Kritchevsky SB, Shardell MD, Dam TT, Vassileva MT. The FNIH sarcopenia project: rationale, study description, conference recommend — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of muscle mass using calf circumference	Measurement with a tape measure (in centimetres) of the maximum circumference of the calf	Day 2
Primary	Measurement of muscle mass using X-ray absorptiometry	Measurement of appendicular mass by X-ray absorptiometry in kilograms	Day 2
Secondary	Arm circumference	Measurement with a tape measure (in centimetres) of the maximum circumference of the arm	Day 0
Secondary	Circumference of the thigh	Measurement with a tape measure (in centimetres) of the maximum circumference of the thigh	Day 0