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FrailityNCT07310667

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

An observational study of Fraility and Nutrition Assessment, run by Ankara Training and Research Hospital at 1 site in Turkey (Türkiye).

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 65 years and older
What is being tested?
Muscle ultrasound
Type of treatment
Medical device
How many people
80 participants
Where
1 siteTurkey (Türkiye)
Study dates
2 May 2025to 31 May 2027
How long will I take part?
1 Week
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

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

Who may be able to join

  • over 65
  • 1 week min stay

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Turkey (Türkiye)1 site

  • Ankara Training And Research Hospital

    Altındağ, Ankara, 06230

Other trials in Turkey (Türkiye)

About this study

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

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.

Read the detailed description

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.

Being tested
Muscle ultrasound
Keywords
Fraility, Nutrition Assessment, Muscle Ultrasound, Muscle Thickness, Critically Ill
Medical subject headings
Critical Illness

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Muscle ultrasoundDevice

    Also called Fraility Scale

    Examine all patients both USG and Fraility scale

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 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

    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

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

  3. 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.)

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

Secondary outcomes (1)

  1. Critical Care Scoring System: APACHE II

    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.

    Measured: During the first 24 hours of ICU admission

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Dec 2025
  2. Study start2 May 2025
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 May 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
80 participants (estimated)
Target duration
1 Week
IDs, dates and publications
ClinicalTrials.gov ID
NCT07310667
Sponsor's protocol ID
13.03.2025_E25-423
Status last verified
Mar 2026
First submitted
25 Jun 2025
Last updated
19 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • 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.

    PubMed 37133796

  • 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.

    PubMed 32919818

  • 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.

    PubMed 37214110

Questions about this trial

What is this clinical trial studying?

An observational study of Fraility and Nutrition Assessment, run by Ankara Training and Research Hospital at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07310667, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.

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