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

NCT ID: NCT06133127

Last Updated: 2025-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-20

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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

Conditions

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Cirrhosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Patients with cirrhosis (45)

Same assessments for all patients (cirrhosis)

Group Type OTHER

Frailty assessment

Intervention Type OTHER

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.

Healthy volunteers (15 subjects)

Same assessments for all healthy volunteers

Group Type OTHER

Frailty assessments

Intervention Type OTHER

Assessments for all healthy volunteers: isometric quadriceps strength, body composition by circumference and triceps skinfold, frailty by LFI and SPPB.

Interventions

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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.

Intervention Type OTHER

Frailty assessments

Assessments for all healthy volunteers: isometric quadriceps strength, body composition by circumference and triceps skinfold, frailty by LFI and SPPB.

Intervention Type OTHER

Eligibility Criteria

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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


* 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

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)


* 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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Clermont-Ferrand

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Armando ABERGEL

Role: PRINCIPAL_INVESTIGATOR

[email protected]

Locations

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CHU clermont-ferrand

Clermont-Ferrand, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Lise LACLAUTRE

Role: CONTACT

334.73.754.963

Facility Contacts

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Lise

Role: primary

334.73.754.963

Other Identifiers

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2023-A01460-45

Identifier Type: OTHER

Identifier Source: secondary_id

RBHP 2023 ABERGEL

Identifier Type: -

Identifier Source: org_study_id

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