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Completed

NCT Number: NCT06133127

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU clermont-ferrand

Clermont-Ferrand, France

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Frailty Assessment

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.

Frailty assessments

Other

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

Primary outcomes

  1. Isometric quadriceps strength

    Time frame: once, at inclusion

    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.

Secondary outcomes

  1. Malnutrition: Royal Free Hospital-Nutritional Prioritizing Tool (RFH-NPT)

    Time frame: once, at inclusion

  2. Malnutrition: Mini Nutritional Assessment (MNA))

    Time frame: once, at inclusion

  3. Body composition by circumference and triceps skinfold

    Time frame: once, at inclusion

  4. Frailty by LFI

    Time frame: once, at inclusion

  5. Frailty by Short Physical Performance Battery (SPPB)

    Time frame: once, at inclusion

  6. Muscle cramps by Cramp questionnaire

    Time frame: once, at inclusion

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Acronym: FRACIR

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Nov 15, 2023
Registry last updated
Apr 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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