Clinical trial NCT06288828: The Efficacy of Aerobic Exercise Training on Autonomic Nervous System and Endothelial Function in Patients with Compensated Cirrhosis
Official title: The Efficacy of Aerobic Exercise Training on Autonomic Nervous System and Endothelial Function in Patients with Compensated Cirrhosis: a Parallel, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cirrhosis
Aerobic Exercises
Lifestyle Modification
Endothelial Function
Autonomic Nervous System
Autonomic Dysfunction
Heart Rate Variability
Flow Mediated Dilation
Sarcopenia
Physical Activity
Physical Functional Performance
Physical Inactivity
Keywords: Cirrhosis
Autonomic nervous system
Endothelial function
Aerobic exercise
Lead sponsor: King Chulalongkorn Memorial Hospital
Sponsor class: OTHER
Collaborators: name: Chulalongkorn University
First posted: 2024-03-01
Enrollment: 70
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: 1.Autonomic function test: Heart rate variability (HRV), Ewing autonomic battery test
timeFrame: The study duration will span from enrollment through treatment completion at 16 weeks or within 2 weeks after the end of the study
measure: Endothelial function test: Flow mediated dilation (FMD) in % FMD change
timeFrame: The study duration will span from enrollment through treatment completion at 16 weeksor within 2 weeks after the end of the study
Secondary outcomes:
measure: Physical function
timeFrame: The study duration will span from enrollment through treatment completion at 16 weeks, plus or minus 2 weeks".
measure: Muscle mass change
timeFrame: The study duration will span from enrollment through treatment completion at 16 weeks, or within 2 weeks after the end of the study
measure: Muscle strength change
timeFrame: The study duration will span from enrollment through treatment completion at 16 weeks, or within 2 weeks after the end of the study
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Faculty of medicine, King Chulalongkorn Memorial Hospital
Study officials:
References: