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

Cirrhosis Clinical Trial

— FRACIR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06133127
• Other study ID #: RBHP 2023 ABERGEL
• Secondary ID: 2023-A01460-45
• Status: Recruiting
• Phase: N/A
• Start date: November 20, 2023
• Est. completion date: December 2025

Study information

• Verified date: October 2023
• Source: University Hospital, Clermont-Ferrand
• Contact: Lise LACLAUTRE
• Phone: 334.73.754.963
• Email: promo_interne_drci[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: December 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Cirrhosis
• Fibrosis
• Liver Cirrhosis

Intervention

Other:
• 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.

Locations

Country	Name	City	State
France	CHU clermont-ferrand	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Malnutrition: Royal Free Hospital-Nutritional Prioritizing Tool (RFH-NPT)		once, at inclusion
Secondary	Malnutrition: Mini Nutritional Assessment (MNA))		once, at inclusion
Secondary	Body composition by circumference and triceps skinfold		once, at inclusion
Secondary	Frailty by LFI		once, at inclusion
Secondary	Frailty by Short Physical Performance Battery (SPPB)		once, at inclusion
Secondary	Muscle cramps by Cramp questionnaire		once, at inclusion