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

NCT06288828 | Active Not Recruiting

• 1 other identifier: IRB0569/66
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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

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

Outcome Measures

Primary Outcomes (2)

• 1.Autonomic function test: Heart rate variability (HRV), Ewing autonomic battery test

  HRV: Time-domain: SDNN (milliseconds), SD of delta NN (milliseconds), o RMSSD, Mean spectrum NN (milliseconds), NN50 (%) Frequency-domain: Very Low-Frequency (VLF) Power, Low-Frequency (LF) Power, High-Frequency (HF) Power , LF/HF Ratio

  The study duration will span from enrollment through treatment completion at 16 weeks or within 2 weeks after the end of the study

• 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 Outcomes (3)

• Physical function

  The study duration will span from enrollment through treatment completion at 16 weeks, plus or minus 2 weeks".

• Muscle mass change

  The study duration will span from enrollment through treatment completion at 16 weeks, or within 2 weeks after the end of the study

• Muscle strength change

  The study duration will span from enrollment through treatment completion at 16 weeks, or within 2 weeks after the end of the study

Study Arms (2)

Exercise group

EXPERIMENTAL

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).

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

Control group

OTHER

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

Behavioral: Nutrition consultant

Interventions

Aerobic exercise + Nutrition consultant 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.

Also known as: Exercise group, Active group

Exercise group

Nutrition consultant 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.

Also known as: diet

Control group; Exercise group

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• King Chulalongkorn Memorial Hospital: lead
• Chulalongkorn University: collaborator

Study Sites (1)

Faculty of medicine, King Chulalongkorn Memorial Hospital

Bangkok, Bangkok, 10330, Thailand

Location

MeSH Terms

Conditions

Fibrosis; Primary Dysautonomias; Sarcopenia; Motor Activity; Sedentary Behavior

Interventions

Exercise; Diet

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Autonomic Nervous System Diseases; Nervous System Diseases; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Atrophy; Pathological Conditions, Anatomical; Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 22, 2024
• First Posted: March 1, 2024
• Study Start: March 12, 2024
• Primary Completion: July 2, 2024
• Study Completion: December 31, 2025
• Last Updated: January 3, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The data will be begin 9 months and end 36 months following article publication.
• Access Criteria: Share via E-mail on request Contact: sirinda.ning@gmail.com

Locations

TH (1)