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Enrolling by Invitation

NCT Number: NCT07310667

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

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.

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Key information

Conditions

Fraility Critical Illness Disease Attributes Nutrition Assessment Pathologic Processes Pathological Conditions, Signs and Symptoms Ultrasound Evaluation

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ankara Training And Research Hospital

Altındağ, Ankara, 06230, Turkey (Türkiye)

About this study

According to the World Health Organization, the global elderly population is rapidly increasing, and this is causing a significant increase in the number of elderly patients admitted to intensive care units (ICUs). The rate of individuals aged 60 and over, which was 12% in 2015, is estimated to reach 22% in 2050. This demographic change significantly increases the use of intensive care beds and the duration of healthcare services by frail and vulnerable elderly individuals. Malnutrition, frailty and mortality rates in patients hospitalized in intensive care units are among the main factors that directly affect patient prognosis. Malnutrition negatively affects both short- and long-term clinical outcomes by causing serious consequences such as weakening of the immune system, increased susceptibility to infections, delayed wound healing and decreased muscle mass. Frailty is characterized by the decrease in physiological reserves due to age and disease and has an important role in predicting clinical deterioration in intensive care patients.

The aim of our study was to investigate the effects of anterior thigh muscle thickness on frailty, malnutrition, and length of stay in intensive care in intensive care patients.

This study was designed as a prospective, observational study. The study will be conducted on patients admitted to the Ankara Education and Research Hospital Anesthesia intensive care unit for any reason after obtaining ethics committee approval.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • over 65
  • 1 week min stay

Exclusion criteria

  • 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.

Treatment and study plan

Muscle ultrasound

Device

Examine all patients both USG and Fraility scale

Other names: Fraility Scale

Primary outcomes

  1. Front Thigh Muscle Measurement

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

    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.

  2. Frailty Assessment

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

    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

  3. Nutritional Status Assessment

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

    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.)

Secondary outcomes

  1. Critical Care Scoring System: APACHE II

    Time frame: During the first 24 hours of ICU admission

    The APACHE II (Acute Physiology and Chronic Health Evaluation II) score is a system used to assess mortality risk in ICU patients. It will be calculated from physiologic and clinical parameters obtained during the first 24 hours of ICU admission. The score is based on acute physiologic variables, age, and chronic health status, and ranges from 0 to 71.

Sponsors and collaborators

Lead sponsor

Ankara Training and Research Hospital

Other

Registry information

Official study title

Assessing the Relationship Between Frailty and Skeletal Muscle Thickness in Critically Ill Patients: A Prospective Observational Study.

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Dec 30, 2025
Registry last updated
Mar 19, 2026

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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