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

NCT ID: NCT06288828

Last Updated: 2025-01-03

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-12
• Study Completion Date: 2025-12-31

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Exercise group

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).

Group Type: EXPERIMENTAL

Aerobic exercise + Nutrition consultant

Intervention Type: BEHAVIORAL

Participants in the intervention group will engage in 150 minutes of moderate aerobic exercise weekly for 16 weeks, primarily brisk walking or jogging.

For the initial four weeks, they will visit the hospital weekly for guidance and participate in home-based exercise following a protocol totaling 150 minutes of moderate aerobic exercise in the form of brisk walking or jogging. Healthcare professionals will help adjust exercise intensity based on heart rate (60-80% of maximum) and perceived exertion (RPE 12-15), while monitoring vital signs and adverse events.

After, they will transition to a home exercise program for twelve weeks, recording exercise details in a logbook. Weekly follow-up calls will ensure adherence and monitor adverse events.

They will be provided with nutritional recommendations by a dietitian, the same as the control group.

Nutrition consultant

Intervention Type: BEHAVIORAL

Participants will maintain their physical activity at the same level as before enrolling in the study.

However, they will be provided with nutritional recommendations by a dietitian, which include 1.2 grams of protein per kilogram of ideal body weight daily and 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 difficulties adhering to the recommended nutritional intake, the dietitian will provide additional guidance to help them meet the requirements.

Control group

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

Group Type: OTHER

Nutrition consultant

Intervention Type: BEHAVIORAL

Participants will maintain their physical activity at the same level as before enrolling in the study.

However, they will be provided with nutritional recommendations by a dietitian, which include 1.2 grams of protein per kilogram of ideal body weight daily and 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 difficulties adhering to the recommended nutritional intake, the dietitian will provide additional guidance to help them meet the requirements.

Interventions

Aerobic exercise + Nutrition consultant

Participants in the intervention group will engage in 150 minutes of moderate aerobic exercise weekly for 16 weeks, primarily brisk walking or jogging.

For the initial four weeks, they will visit the hospital weekly for guidance and participate in home-based exercise following a protocol totaling 150 minutes of moderate aerobic exercise in the form of brisk walking or jogging. Healthcare professionals will help adjust exercise intensity based on heart rate (60-80% of maximum) and perceived exertion (RPE 12-15), while monitoring vital signs and adverse events.

After, they will transition to a home exercise program for twelve weeks, recording exercise details in a logbook. Weekly follow-up calls will ensure adherence and monitor adverse events.

They will be provided with nutritional recommendations by a dietitian, the same as the control group.

Intervention Type: BEHAVIORAL

Nutrition consultant

Participants will maintain their physical activity at the same level as before enrolling in the study.

However, they will be provided with nutritional recommendations by a dietitian, which include 1.2 grams of protein per kilogram of ideal body weight daily and 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 difficulties adhering to the recommended nutritional intake, the dietitian will provide additional guidance to help them meet the requirements.

Intervention Type: BEHAVIORAL

Other Intervention Names

Exercise group; Active group; diet

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chulalongkorn University

OTHER

Sponsor Role: collaborator

King Chulalongkorn Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Sirinda Kittiprachakul

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of medicine, King Chulalongkorn Memorial Hospital

Bangkok, Bangkok, Thailand

Countries

Thailand

Other Identifiers

IRB0569/66

Identifier Type: -

Identifier Source: org_study_id