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

University Hospital, Clermont-Ferrand

Status: Enrolling

Conditions: Cirrhosis

Treatments: Other: Frailty assessments; Other: Frailty assessment

Study type: Interventional

Funder types: Other

Identifiers

NCT06133127

2023-A01460-45 (Other Identifier)

RBHP 2023 ABERGEL

Details and patient eligibility

About

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.

Full description

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

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Patients with cirrhosis (45)

Other group

Description:

Same assessments for all patients (cirrhosis)

Treatment:

Other: Frailty assessment

Healthy volunteers (15 subjects)

Other group

Description:

Same assessments for all healthy volunteers

Treatment:

Other: Frailty assessments