The Efficacy of Aerobic Exercise Training on Autonomic Nervous System and Endothelial Function in Patients with Compensated Cirrhosis

King Chulalongkorn Memorial Hospital

Status: Active, not recruiting

Conditions: Endothelial Function; Physical Inactivity; Cirrhosis; Heart Rate Variability; Flow Mediated Dilation; Autonomic Nervous System; Lifestyle Modification; Physical Activity; Aerobic Exercises; Physical Functional Performance; Sarcopenia; Autonomic Dysfunction

Treatments: Behavioral: Nutrition consultant; Behavioral: Aerobic exercise + Nutrition consultant

Study type: Interventional

Funder types: Other

Identifiers

NCT06288828

IRB0569/66

Details and patient eligibility

About

The goal of this clinical trial is to explore the impact of a 16-week aerobic exercise regimen on the autonomic nervous system and endothelial function in patients with compensated cirrhosis who have physical inactivity. The primary research question is:

1. What effect does 16 weeks of aerobic exercise have on changes in the autonomic nervous system and endothelial function in cirrhotic patients?

Additionally, the secondary research questions are:

1. How does a 16-week aerobic exercise program influence changes in muscle mass, muscle strength, and physical performance in cirrhotic patients?
2. Is there a correlation between muscle mass and parameters of the autonomic nervous system in cirrhotic patients?

Participants in the intervention group will undergo 150 minutes of moderate aerobic exercise per week for 16 weeks, accompanied by a personalized nutritional plan (1.2 grams of protein per kilogram of ideal body weight per day and a calorie intake of 35 kilocalories per kilogram of ideal body weight per day). The control group will solely receive nutritional guidance and maintain their physical inactivity. The researchers will compare outcomes between these two groups.

Enrollment: 70 estimated patients

Sex: All

Ages: 45 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The diagnosis of cirrhosis is confirmed either through liver biopsy ,and/or compatible features on ultrasonography/ computer tomography or magnetic resonance imaging.
• The age range is between 45 and 75 years.
• Participants are classified as Child Pugh score class A.
• Participants report a physical inactivity, defined as engaging in physical activity for less than 150 minutes of moderate-intensity physical activity per week, or less than 75 minutes of vigorous-intensity physical activity per week, or an equivalent combination of both.

Exclusion criteria

• Active hepatocellular carcinoma (HCC) or remission of HCC within the past 3 months.
• Untreated large esophageal varices (EV) greater than F2 or history of upper gastrointestinal bleeding from portal hypertension or gastric varices.
• Active or history of hepatic encephalopathy (HE).
• Inpatient hospitalization for any reason or discharge from the hospital within the past 3 months.
• Complete portal vein thrombosis.
• Transjugular intrahepatic portosystemic shunt.
• Contraindications to exercise, such as recent myocardial infarction, unstable angina, electrocardiography changes within the past 24 hours, complete heart block, acute congestive heart failure, uncontrolled hypertension, hemoglobin level less than 11 g/dL, platelet count less than 50,000 cells/mm 3 .
• End-stage renal disease without dialysis.
• Severe orthopedic problems that limit the ability to exercise.
• Inability to communicate with the research team via telemedicine system.
• Body mass index (BMI) exceeding 35 kg/m 2 .
• On alpha or beta-blocker

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

70 participants in 2 patient groups

Exercise group

Experimental group

Description:

Participants in the intervention group will undergo 150 minutes of moderate aerobic exercise per week for 16 weeks, accompanied by a personalized nutritional plan (1.2 grams of protein per kilogram of ideal body weight per day and a calorie intake of 35 kilocalories per kilogram of ideal body weight per day).

Treatment:

Behavioral: Aerobic exercise + Nutrition consultant

Behavioral: Nutrition consultant

Control group

Other group

Description:

The control group will solely receive nutritional guidance and maintain their physical inactivity.

Treatment:

Behavioral: Nutrition consultant