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The efficacy and safety of liver rehabilitation for patients with chronic liver disease: a prospective clinical trial.

The efficacy and safety of liver rehabilitation for patients with chronic liver disease: a prospective clinical trial.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1040230078
Enrollment
45
Registered
2023-09-06
Start date
2023-09-06
Completion date
Unknown
Last updated
2025-07-18

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

Conditions

Patients diagnosed with chronic hepatitis, cirrhosis, or liver cancer chronic liver disease

Interventions

We will evaluate the physical assessment (walking test, sarcopenia, frailty), QOL, and liver reserve function of patients with chronic hepatitis, cirrhosis, and liver cancer, and implement a comprehen
liver rehabilitation

Sponsors

Shimizu Masahito
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients aged 20 or older 2. Patients diagnosed with chronic hepatitis, cirrhosis, or liver cancer by histological or clinical criteria (regardless of etiology) 3. Patients with exercise tolerance

Exclusion criteria

Exclusion criteria: 1. Patients with reduced liver reserve function (Child-Pugh class C and/or MELD score 20 or higher) 2. Patients with esophageal-gastric varices that require treatment 3. Patients with hepatic encephalopathy 4. Patients with refractory ascites 5. Anemia or thrombocytopenia 6. Mental or physical disabilities that prevent safe exercise therapy 7. Uncontrolled systemic diseases (infections, electrolyte abnormalities, thyroid dysfunction, etc.) 8. Signs or symptoms (chest discomfort, dyspnea, dizziness, syncope, palpitations, heart murmur, etc.) during exertion 9. Past or present medical conditions (history of myocardial infarction, pacemaker/implantable cardioverter-defibrillator/rhythm disorder, valvular heart disease, heart failure, heart transplant, congenital heart disease) 10 Heart rate (>100 mmHg or 160 mmHg or 110 mmHg or <50 mmHg), percutaneous oxygen saturation (SpO2<92%) 11. Specific musculoskeletal limitations (arthritis, joint swelling, or conditions that limit walking or daily activities) 12. Three or more falls in the past year: risk level II or higher in the Gifu University Fall Assessment.

Design outcomes

Primary

MeasureTime frame
1. To clarify the effect of liver rehabilitation on physical function assessment measurements [six-minute walk test (6MWT), Short physical performance battery (SPPB), balance function test, knee extension muscle strength measurement, grip strength measurement, frailty (Liver Frailty Index: LFI), muscle mass measurement, sarcopenia, average number of steps, activity level. 2. To confirm the safety of liver rehabilitation (presence or absence of adverse events)

Secondary

MeasureTime frame
1. Improvement of readmission rate by liver rehabilitation 2. Improvement of liver disease-specific QOL assessment 3. Impact of liver rehabilitation on liver reserve function 4. Association of liver rehabilitation with liver-related events (ascites, encephalopathy, variceal rupture)

Contacts

Public ContactTatsunori Hanai

Gifu University Hospital

hanai.tatsunori.p8@f.gifu-u.ac.jp+81-58-230-6308

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Feb 4, 2026