Is There an Association Between Quadriceps Strength and Different Markers of Fragility in Patients With Cirrhosis? (FRACIR)

Physical frailty and malnutrition are important factors in morbidity and mortality in patients with cirrhosis. No study has assessed the validity of Liver Frailty Index (LFI) against reference measures such as maximal lower limb strength.

Main objective: To assess the association between LFI score and isometric maximal lower limb strength (quadriceps) in patients with cirrhosis.

Study Overview

• Status: Completed
• Conditions: Cirrhosis
• Intervention / Treatment: Other: Frailty assessment; Other: Frailty assessments

Detailed Description

Secondary objective: compare the different strength parameters of patients with cirrhosis (strength endurance, rate of strength development) with healthy subjects.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France
    • Chu Clermont-Ferrand

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

SUBJECT :

• with a diagnosis of liver cirrhosis (regardless of cirrhosis stage and etiology)
• under the care of a physician practising in the University Hospital Estaing in Clermont-Ferrand
• affiliated to the french social security system

Exclusion Criteria:

SUBJECT:

• with hepatocellular carcinoma
• with HIV infection
• with hepatic encephalopathy grade ≥ 2
• with cognitive dysfunction
• with contraindication for physical activity
• with knee pain/knee disorders
• pregnant or breastfeeding
• under protective supervision (guardianship, curatorship, protection of the court)

Inclusion Criteria for healthy volonteers:

• male subjects aged 52 to 62
• female subjects aged 42 to 60
• BMI between 20 and 30 kg/m2
• no musculoskeletal problems limiting physical activity
• level of physical activity < 3 hours per week
• affiliated to the french social security system

Exclusion Criteria for healthy volonteers:

• medical or surgical history deemed incompatible with the trial by the investigator
• simultaneous participation in a trial involving a drug or medical device, or period of exclusion from such a trial
• participants protected by law (under guardianship, conservatorship, or protection of the court)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Healthy volunteers (15 subjects); Same assessments for all healthy volunteers	Other: Frailty assessments; Assessments for all healthy volunteers: isometric quadriceps strength, body composition by circumference and triceps skinfold, frailty by LFI and SPPB.
Other: Patients with cirrhosis (45); Same assessments for all patients (cirrhosis)	Other: Frailty assessment; Assessments for all patients : isometric quadriceps strength, malnutrition by RFH-NPT and MNA questionnaires, body composition by circumference and triceps skinfold, frailty by LFI and SPPB, muscle cramps by Cramp questionnaire.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Isometric quadriceps strength	Isometric quadriceps strength (N.m) will be assessed 3 times with 30 second rest between each try. The dominant leg of each participant will be assessed, a standardised warm-up will be conducted to have effective results.	once, at inclusion

Secondary Outcome Measures

Outcome Measure	Time Frame
Malnutrition: Royal Free Hospital-Nutritional Prioritizing Tool (RFH-NPT)	once, at inclusion
Malnutrition: Mini Nutritional Assessment (MNA))	once, at inclusion
Body composition by circumference and triceps skinfold	once, at inclusion
Frailty by LFI	once, at inclusion
Frailty by Short Physical Performance Battery (SPPB)	once, at inclusion
Muscle cramps by Cramp questionnaire	once, at inclusion

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand
• Investigators: Principal Investigator: Armando ABERGEL, aabergel@chu-clermontferrand.fr

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2023
• Primary Completion (Actual): March 26, 2026
• Study Completion (Actual): March 26, 2026

Study Registration Dates

• First Submitted: October 31, 2023
• First Submitted That Met QC Criteria: November 9, 2023
• First Posted (Actual): November 15, 2023

Study Record Updates

• Last Update Posted (Actual): April 6, 2026
• Last Update Submitted That Met QC Criteria: March 31, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Quadriceps strength; Frailty markers
• Additional Relevant MeSH Terms: Pathologic Processes; Pathological Conditions, Signs and Symptoms; Fibrosis
• Other Study ID Numbers: RBHP 2023 ABERGEL; 2023-A01460-45 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No