CirrhosisFRACIRNCT06133127
Is There an Association Between Quadriceps Strength and Different Markers of Fragility in Patients With Cirrhosis?
A study testing Frailty assessment and Frailty assessments in people with Cirrhosis, run by University Hospital, Clermont-Ferrand at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Cirrhosis
- What is being tested?
- Frailty assessment and Frailty assessments
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 20 Nov 2023to 26 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- SUBJECT:
- with hepatocellular carcinoma
- with HIV infection
- with hepatic encephalopathy grade ≥ 2
- with cognitive dysfunction
- with contraindication for physical activity
Show all 12Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Secondary objective: compare the different strength parameters of patients with cirrhosis (strength endurance, rate of strength development) with healthy subjects.
- Conditions
- Cirrhosis
- Being tested
- Frailty assessment, Frailty assessments
- Keywords
- Frailty markers, Quadriceps strength
- Medical subject headings
- Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Frailty assessmentsOther
Assessments for all healthy volunteers: isometric quadriceps strength, body composition by circumference and triceps skinfold, frailty by LFI and SPPB.
| Study group | Role | What they receive |
|---|---|---|
| Patients with cirrhosis (45) | Other | Same assessments for all patients (cirrhosis) Receives: Other: Frailty assessment |
| Healthy volunteers (15 subjects) | Other | Same assessments for all healthy volunteers Receives: Other: Frailty assessments |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: once, at inclusion
Secondary outcomes (6)
Malnutrition: Royal Free Hospital-Nutritional Prioritizing Tool (RFH-NPT)
Measured: once, at inclusion
Malnutrition: Mini Nutritional Assessment (MNA))
Measured: once, at inclusion
Body composition by circumference and triceps skinfold
Measured: once, at inclusion
Frailty by LFI
Measured: once, at inclusion
Frailty by Short Physical Performance Battery (SPPB)
Measured: once, at inclusion
Muscle cramps by Cramp questionnaire
Measured: once, at inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2023
- Study start20 Nov 2023
- Primary completion26 Mar 2026
- Study completion26 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CirrhosisStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Armando ABERGEL, Principal investigator, aabergel@chu-clermontferrand.fr
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06133127
- Sponsor's protocol ID
- RBHP 2023 ABERGEL
- Other IDs
- 2023-A01460-45
- Acronym
- FRACIR
- Status last verified
- Mar 2026
- First submitted
- 31 Oct 2023
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is There an Association Between Quadriceps Strength and Different Markers of Fragility in Patients With Cirrhosis?
- ClinicalTrials.gov ID
- NCT06133127
- Acronym / sponsor ID
- FRACIR / RBHP 2023 ABERGEL
- Conditions
- Cirrhosis
- Keywords
- Frailty markers, Quadriceps strength
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 20 Nov 2023 (actual)
- Primary completion
- 26 Mar 2026 (actual)
- Study completion
- 26 Mar 2026 (actual)
- First posted
- 15 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with cirrhosis (45) | Other | Other: Frailty assessmentSame assessments for all patients (cirrhosis) |
| Healthy volunteers (15 subjects) | Other | Other: Frailty assessmentsSame assessments for all healthy volunteers |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (12 listed)
- with hepatocellular carcinoma
- with HIV infection
- with hepatic encephalopathy grade ≥ 2
- with cognitive dysfunction
- with contraindication for physical activity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Frailty assessmentAssessments 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. | Other | Patients with cirrhosis (45) |
| Frailty assessmentsAssessments for all healthy volunteers: isometric quadriceps strength, body composition by circumference and triceps skinfold, frailty by LFI and SPPB. | Other | Healthy volunteers (15 subjects) |
Primary outcome
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.
6 secondary outcomes
Malnutrition: Royal Free Hospital-Nutritional Prioritizing Tool (RFH-NPT)
Time frame: once, at inclusion
Malnutrition: Mini Nutritional Assessment (MNA))
Time frame: once, at inclusion
Body composition by circumference and triceps skinfold
Time frame: once, at inclusion
Frailty by LFI
Time frame: once, at inclusion
Frailty by Short Physical Performance Battery (SPPB)
Time frame: once, at inclusion
Muscle cramps by Cramp questionnaire
Time frame: once, at inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Armando ABERGEL principal investigator
aabergel@chu-clermontferrand.fr
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Frailty assessment and Frailty assessments in people with Cirrhosis, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Isometric quadriceps strength (time frame: once, at inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2026.