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

Physical Activity Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06288828
• Other study ID #: IRB0569/66
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 5, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: February 2024
• Source: King Chulalongkorn Memorial Hospital
• Contact: Sirinda Kittiprachakul
• Phone: 66+863979908
• Email: sirinda.ning[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 maintain sedentary lifestyles. 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 sedentary lifestyle. The researchers will compare outcomes between these two groups.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: December 31, 2025
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 75 Years

Eligibility

Inclusion Criteria:

• The diagnosis of cirrhosis is confirmed either through liver biopsy or the presence of portal hypertension, evidenced by esophageal varices on endoscopy, ascites, and/or compatible features on ultrasonography.
• The age range is between 45 and 75 years.
• Participants are classified as Child Pugh score class A.
• Participants report a sedentary lifestyle, 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 .
• Use of Vitamin E and C supplements.
• 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 30 kg/m 2 .

Related Conditions & MeSH terms

• Autonomic Dysfunction
• Autonomic Nervous System
• Autonomic Nervous System Diseases
• Cirrhosis
• Endothelial Function
• Fibrosis
• Flow Mediated Dilation
• Heart Rate Variability
• Lifestyle Modification
• Liver Cirrhosis
• Physical Activity
• Physical Functional Performance
• Primary Dysautonomias
• Sarcopenia

Intervention

Behavioral:
• Aerobic exercise
Participants in the intervention group will engage in 150 minutes of moderate aerobic exercise weekly for 16 weeks, primarily brisk walking or jogging. They will follow a personalized nutritional plan: 1.2 grams of protein per kilogram of ideal body weight daily and 35 kilocalories per kilogram of ideal body weight daily. For the initial four weeks, they will visit the hospital weekly for guidance. Healthcare professionals will help adjust exercise intensity based on heart rate (60-80% of max) and perceived exertion (RPE 12-15), monitoring vital signs and adverse events. After, they will transition to a home exercise program for eight weeks, recording exercise details in a logbook. Weekly follow-up calls will ensure adherence and monitor adverse events.
• Nutrition consultant
Participants will be provided with a personalized nutritional plan by a nutritionist, which will involve consuming 1.2 grams of protein per kilogram of ideal body weight daily, while also maintaining a calorie intake of 35 kilocalories per kilogram of ideal body weight per day. To assess adherence and make necessary adjustments, participants will complete a 3-day food record at the beginning of the study, at week 8, and at the end of the study at week 16. If participants encounter difficulty in adhering to the recommended nutritional intake, the nutritionist will offer additional guidance to help them meet the requirements. The primary objective of this nutritional plan is to ensure that participants receive adequate nutrition to support their exercise regimen and maintain their body weight throughout the study period.

Locations

Country	Name	City	State
Thailand	Faculty of medicine, King Chulalongkorn Memorial Hospital	Bangkok

Sponsors (2)

Lead Sponsor	Collaborator
King Chulalongkorn Memorial Hospital	Chulalongkorn University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Autonomic function test: Heart rate variability (HRV)	in form of parameter change: Time-domain methods-; SDNN (milliseconds), SD of delta NN (milliseconds), o RMSSD, Mean spectrum NN (milliseconds), NN50 (%); Frequency method:	The study duration will span from enrollment through treatment completion at 16 weeks or within 2 weeks after the end of the study
Primary	Endothelial function test: Flow mediated dilation (FMD) in % FMD change		The study duration will span from enrollment through treatment completion at 16 weeksor within 2 weeks after the end of the study
Secondary	Physical function	6-minute walk test (minute)	The study duration will span from enrollment through treatment completion at 16 weeks, plus or minus 2 weeks".
Secondary	Muscle mass change	Lean appendicular mass (kg) from Dual energy X-ray absorptiometry (DXA)	The study duration will span from enrollment through treatment completion at 16 weeks, or within 2 weeks after the end of the study
Secondary	Muscle strength change	Handgrip strength (kg) from dynamometer	The study duration will span from enrollment through treatment completion at 16 weeks, or within 2 weeks after the end of the study