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

JRCT ID: jRCT1040230078

Registered date:06/09/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Patients diagnosed with chronic hepatitis, cirrhosis, or liver cancer
• Date of first enrollment: 06/09/2023
• Target sample size: 45
• Study type: Interventional
• Intervention(s): 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 comprehensive treatment (liver rehabilitation) for chronic liver disease, which includes exercise therapy as the main component, as well as lifestyle guidance, nutritional guidance, and pharmacotherapy. The exercise therapy will be mainly aerobic exercise (walking) according to the guidelines of the American College of Sports Medicine (ACSM). Resistance exercise will be added for patients who are judged to have sufficient exercise tolerance. We will conduct a 12-week intervention study to verify the improvement of exercise tolerance, muscle strength and muscle mass (sarcopenia/frailty), and health-related QOL by liver rehabilitation, and to evaluate the efficacy and safety of liver rehabilitation.

Outcome(s)

Primary Outcome

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 Outcome

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)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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.

Related Information

• Primary Sponsor: Shimizu Masahito