NCT06133127

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
7mo left

Started Nov 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress81%
Nov 2023Dec 2026

First Submitted

Initial submission to the registry

October 31, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

November 15, 2023

Completed
5 days until next milestone

Study Start

First participant enrolled

November 20, 2023

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

December 4, 2025

Status Verified

September 1, 2025

Enrollment Period

2.4 years

First QC Date

October 31, 2023

Last Update Submit

November 26, 2025

Conditions

Cirrhosis

Keywords

Frailty markersQuadriceps strength

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • 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

  • +1 more secondary outcomes

Study Arms (2)

Patients with cirrhosis (45)

OTHER

Same assessments for all patients (cirrhosis)

Other: Frailty assessment

Healthy volunteers (15 subjects)

OTHER

Same assessments for all healthy volunteers

Other: Frailty assessments

Interventions

Frailty assessmentOTHER

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.

Patients with cirrhosis (45)
Frailty assessmentsOTHER

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

Healthy volunteers (15 subjects)

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)
  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU clermont-ferrand

Clermont-Ferrand, France

RECRUITING

MeSH Terms

Conditions

Fibrosis

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Armando ABERGEL

    aabergel@chu-clermontferrand.fr

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lise LACLAUTRE

CONTACT

334.73.754.963promo_interne_drci@chu-clermontferrand.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 31, 2023

First Posted

November 15, 2023

Study Start

November 20, 2023

Primary Completion

May 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

December 4, 2025

Record last verified: 2025-09

Locations

FR(1)