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

Not Applicable

Recruiting

• Conditions: Patients diagnosed with chronic hepatitis, cirrhosis, or liver cancer; chronic liver disease; D008103

• Registration Number: JPRN-jRCT1040230078
• Lead Sponsor: Shimizu Masahito

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-09-06
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 45

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

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 <50 mmHg), systolic blood pressure (>160 mmHg or <85 mmHg), diastolic blood pressure (>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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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. <br>2. To confirm the safety of liver rehabilitation (presence or absence of adverse events)

Secondary Outcome Measures

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