Skip to content

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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06133127
Acronym
FRACIR
Enrollment
60
Registered
2023-11-15
Start date
2023-11-20
Completion date
2026-12-31
Last updated
2025-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cirrhosis

Keywords

Frailty markers, Quadriceps strength

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.

Detailed description

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

Interventions

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.

OTHERFrailty assessments

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

Sponsors

University Hospital, Clermont-Ferrand
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Isometric quadriceps strengthonce, at inclusionIsometric 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

MeasureTime frame
Malnutrition: Mini Nutritional Assessment (MNA))once, at inclusion
Body composition by circumference and triceps skinfoldonce, at inclusion
Malnutrition: Royal Free Hospital-Nutritional Prioritizing Tool (RFH-NPT)once, at inclusion
Frailty by Short Physical Performance Battery (SPPB)once, at inclusion
Muscle cramps by Cramp questionnaireonce, at inclusion
Frailty by LFIonce, at inclusion

Countries

France

Contacts

Primary ContactLise LACLAUTRE
promo_interne_drci@chu-clermontferrand.fr334.73.754.963

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026