NCT06288828

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

The Efficacy of Aerobic Exercise Training on Autonomic Nervous System and Endothelial Function in Patients with Compensated Cirrhosis: a Parallel, Randomized Controlled Trial

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: King Chulalongkorn Memorial Hospital · Academic / Other
• Sex: All
• Age: 45 Years – 75 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
BEHAVIORAL	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.
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.

Timeline

• Start date: 2024-03-12
• Primary completion: 2024-07-02
• Completion: 2025-12-31
• First posted: 2024-03-01
• Last updated: 2025-01-03

Locations

1 site across 1 country: Thailand