Assessing the Relationship Between Frailty and Skeletal Muscle Thickness in Critically Ill Patients

NCT07310667 | Enrolling By Invitation

• 1 other identifier: 13.03.2025_E25-423
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Assessment of muscle mass in critically ill patients is critical for both improving clinical outcomes and monitoring the effectiveness of nutritional interventions. Loss of muscle mass is associated with mortality and morbidity in the elderly, including organ transplantation, trauma, and sepsis. Previous studies have assessed muscle mass using computed tomography. The use of computed tomography is costly, carries radiation risks, and requires the patient to be transported to a CT scanner. In contrast, ultrasonography is a noninvasive, rapid, and bedside method without radiation exposure. In particular, anterior thigh muscle thickness (ATMT) stands out as a reliable biomarker in the assessment of muscle mass. ATMT measurement includes the assessment of the combined depth of the vastus intermedius and rectus femoris muscles in the anterior thigh. There is no study in the literature examining the effects of anterior thigh muscle thickness measured by ultrasonography on malnutrition and frailty in intensive care patients. In this study, we aimed to investigate the effects of anterior thigh muscle thickness on frailty, malnutrition and length of stay in intensive care patients.

Conditions

Nutrition Assessment; Ultrasound Evaluation; Critical Illness; Fraility

Keywords

Fraility; Nutrition Assessment; Muscle Ultrasound; Muscle Thickness; Critically Ill

Outcome Measures

Primary Outcomes (3)

• Front Thigh Muscle Measurement

  Anterior thigh muscle thickness will be measured using ultrasonography with a linear transducer operating at 5-10 MHz. Using ample gel and minimal probe compression, the measurement site will be marked at the midpoint between the anterior superior iliac spine (SIAS) and the superior pole of the patella. Total quadriceps thickness-defined as the combined thickness of the rectus femoris and vastus intermedius-will then be recorded. Thickness will be measured as milimeter. Ultrasound assessments will be performed within 24 hours of intensive care unit (ICU) admission and repeated on ICU days 3 and 7.

  Ultrasound assessments will be performed within 24 hours of intensive care unit (ICU) admission and repeated on ICU days 3 and 7.

• Frailty Assessment

  Frailty will be assessed using the Clinical Frailty Scale (CFS). Frailty status will be determined at the time of ICU admission by interviewing family members/caregivers to ascertain the patient's frailty level prior to the acute illness and hospitalization. Clinical Frailty Scale (CFS): 1 Very fit; 2 Well; 3 Managing well; 4 Vulnerable-independent but slowed, fatigued; 5 Mildly frail-needs help with instrumental ADLs (finances, transport, heavy housework, meds); 6 Moderately frail-needs help with all outside activities/housework; may need minimal help bathing/dressing; 7 Severely frail-dependent for personal care but clinically stable; 8 Very severely frail-dependent, near end of life; 9 Terminally ill-life expectancy \<6 months. Classification: 1-3 non-frail; 4 pre-frail; ≥5 frail

  Frailty will be ascertained at ICU admission by interviewing family/caregivers about the patient's frailty level prior to the acute illness and hospitalization.

• Nutritional Status Assessment

  Assessment nutritional risk in ICU patients and identify those at high risk of malnutrition, the NRS-2002, GLIM criteria, and the NUTRIC score will be used. (NRS-2002: Nutritional Risk Screening 2002; GLIM: Global Leadership Initiative on Malnutrition; NUTRIC: Nutrition Risk in the Critically Ill.)

  Will be ascertained at ICU admission by interviewing with family/caregivers

Secondary Outcomes (1)

• Critical Care Scoring System: APACHE II

  During the first 24 hours of ICU admission

Interventions

Muscle ultrasound DEVICE

Examine all patients both USG and Fraility scale

Also known as: Fraility Scale

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Over 65 years, critically ill patients, who are submitted to ICU.

You may qualify if:

• over 65
• week min stay

You may not qualify if:

• Patients under 65 years of age
• those with cardiac arrest, terminal illnesses, advanced cancer, advanced neurodegenerative diseases,
• those with knee or hip prosthesis that would affect the anterior thigh muscle thickness measurement those whose intensive care stay did not exceed 1 week will be excluded.

Sponsors & Collaborators

• Ankara Training and Research Hospital: lead

Study Sites (1)

Ankara Training And Research Hospital

Altındağ, Ankara, 06230, Turkey (Türkiye)

Location

Related Publications (3)

• Bruno RR, Wernly B, Bagshaw SM, van den Boogaard M, Darvall JN, De Geer L, de Gopegui Miguelena PR, Heyland DK, Hewitt D, Hope AA, Langlais E, Le Maguet P, Montgomery CL, Papageorgiou D, Seguin P, Geense WW, Silva-Obregon JA, Wolff G, Polzin A, Dannenberg L, Kelm M, Flaatten H, Beil M, Franz M, Sviri S, Leaver S, Guidet B, Boumendil A, Jung C. The Clinical Frailty Scale for mortality prediction of old acutely admitted intensive care patients: a meta-analysis of individual patient-level data. Ann Intensive Care. 2023 May 3;13(1):37. doi: 10.1186/s13613-023-01132-x.

  PMID: 37133796 BACKGROUND

• Lee ZY, Ong SP, Ng CC, Yap CSL, Engkasan JP, Barakatun-Nisak MY, Heyland DK, Hasan MS. Association between ultrasound quadriceps muscle status with premorbid functional status and 60-day mortality in mechanically ventilated critically ill patient: A single-center prospective observational study. Clin Nutr. 2021 Mar;40(3):1338-1347. doi: 10.1016/j.clnu.2020.08.022. Epub 2020 Aug 28.

  PMID: 32919818 BACKGROUND

• Kalaiselvan MS, Yadav A, Kaur R, Menon A, Wasnik S. Prevalence of Frailty in ICU and its Impact on Patients' Outcomes. Indian J Crit Care Med. 2023 May;27(5):335-341. doi: 10.5005/jp-journals-10071-24456.

  PMID: 37214110 BACKGROUND

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Week
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 25, 2025
• First Posted: December 30, 2025
• Study Start: May 2, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): May 31, 2027
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: between January 1st 2026 and May 1st 2026

Locations

TU (1)