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
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.
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 . |
Country | Name | City | State |
---|---|---|---|
Thailand | Faculty of medicine, King Chulalongkorn Memorial Hospital | Bangkok |
Lead Sponsor | Collaborator |
---|---|
King Chulalongkorn Memorial Hospital | Chulalongkorn University |
Thailand,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT05661799 -
Persistence of Physical Activity in People With Type 2 Diabetes Over Time.
|
N/A | |
Active, not recruiting |
NCT03903874 -
Testing Scalable, IVR-supported Cancer Prevention Interventions in the Rural Alabama Black Belt
|
N/A | |
Recruiting |
NCT03662438 -
HOPE (Home-based Oxygen [Portable] and Exercise) for Patients on Long Term Oxygen Therapy (LTOT)
|
N/A | |
Withdrawn |
NCT04540523 -
Home-Based Exergaming Intervention
|
N/A | |
Recruiting |
NCT03250000 -
Changes in Microcirculation and Functional Status During Exacerbation of COPD
|
N/A | |
Recruiting |
NCT05563805 -
Exploring Virtual Reality Adventure Training Exergaming
|
N/A | |
Completed |
NCT03430648 -
Is Tau Protein Linked to Mobility Function?
|
||
Completed |
NCT05019482 -
Intervention Program Among University Student to Promote Physical Activity and Reduce the Sedentary Time
|
N/A | |
Completed |
NCT03253406 -
Health Wearables and College Student Health
|
N/A | |
Not yet recruiting |
NCT05985460 -
A Very Brief Intervention to Increase the Intention to Practice Physical Activity
|
N/A | |
Completed |
NCT03380143 -
Whole-of-Community Youth Population Physical Activity
|
N/A | |
Completed |
NCT03700736 -
The Healthy Moms Study: Comparison of a Post-Partum Weight Loss Intervention Delivered Via Facebook or In-Person Groups
|
N/A | |
Completed |
NCT03170921 -
Psychophysiological Characterization of Different Capoeira Performances in Experienced Individuals
|
N/A | |
Completed |
NCT04973813 -
Active Choice Intervention About Physical Activity for Physically Inactive Adults
|
N/A | |
Completed |
NCT03982095 -
Survey on Lifestyle, Perceived Barriers and Development of Change in Patients With Prostate Cancer
|
||
Completed |
NCT03271112 -
Frailty Prevention in Elders From Reunion Island
|
N/A | |
Completed |
NCT05670223 -
Healthy Activities Improve Lives
|
N/A | |
Completed |
NCT04894929 -
Comprehensive Geriatric Assessment in the Monitoring of Functional Improvement
|
N/A | |
Recruiting |
NCT04578067 -
Empowering Immigrant Women for Active and Healthy Lifestyle
|
N/A | |
Completed |
NCT03297567 -
Physical Therapy Guidelines For Hospitalized Elderly
|
N/A |