CirrhosisNCT06288828
The Efficacy of Aerobic Exercise Training on ANS and Endothelial Function in Compensated Cirrhosis
A study testing Aerobic exercise + Nutrition consultant and Nutrition consultant in people with Cirrhosis and Aerobic Exercises, run by King Chulalongkorn Memorial Hospital at 1 site in Thailand.
Trial summary
The goal of this randomized controlled trial is to investigate whether a 16-week structured aerobic exercise program combined with nutritional consultation can improve autonomic and endothelial function in patients with compensated cirrhosis. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Cirrhosis, Aerobic Exercises, Lifestyle Modification
- What is being tested?
- Aerobic exercise + Nutrition consultant and Nutrition consultant
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteThailand
- Study dates
- 12 Mar 2024to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Faculty of medicine, King Chulalongkorn Memorial Hospital
Bangkok, Bangkok, 10330
About this study
Official title: The Efficacy Of Aerobic Exercise Training On Autonomic Nervous System And Endothelial Function In Patients With Compensated Cirrhosis: A Parallel, RCT Study
The goal of this randomized controlled trial is to investigate whether a 16-week structured aerobic exercise program combined with nutritional consultation can improve autonomic and endothelial function in patients with compensated cirrhosis.
Study Design:
Read more
This assessor-blinded, parallel-group randomized controlled trial will be conducted at King Chulalongkorn Memorial Hospital, Bangkok, Thailand. Fifty adults with compensated (Child-Pugh class A) cirrhosis will be recruited during routine hepatology clinic visits. Eligible participants are aged 45-75 years, have a sedentary lifestyle (<150 minutes of moderate or <75 minutes of vigorous physical activity per week), and have abstained from alcohol for at least six months.
Exclusion criteria include active or recently treated hepatocellular carcinoma (within three months), severe portal hypertension complications (untreated large varices, prior variceal bleeding, or severe gastropathy), transjugular intrahepatic portosystemic shunt (TIPS), unstable cardiac disease, orthopedic limitations, morbid obesity (BMI >35 kg/m²), or current use of alpha- or beta-blockers that affect autonomic function.
Intervention:
Participants will be randomly assigned to either the intervention or control group. Both groups will receive nutritional consultation and individualized dietary guidance at baseline, week 8, and week 16. Nutritional goals are set at 35 kcal/kg/day and 1.2 g/kg/day of protein intake. If targets are unmet, the dietitian will provide individualized recommendations to support adequate intake.
The intervention group will participate in a 16-week aerobic exercise program consisting of brisk walking at moderate intensity (50-70% of maximal heart rate), totaling 150 minutes per week. The program includes two phases:
- Phase 1 (Weeks 1-4): Combined hospital-based (1 session per week) and home-based exercise under physical therapist supervision, with gradual intensity titration.
- Phase 2 (Weeks 5-16): Fully home-based exercise following prescribed intensity and frequency, with weekly follow-up via telephone or messaging to monitor adherence, safety, and exercise log completion.
The control group will maintain their usual physical activity levels while receiving the same schedule of nutritional consultations and weekly follow-up for monitoring compliance and adverse events.
Outcomes:
Primary outcomes include changes in autonomic and endothelial function after 16 weeks.
- Autonomic function will be assessed using the Ewing autonomic battery test (HR response to standing, deep breathing, and Valsalva maneuver; BP response to posture and sustained handgrip) and heart rate variability (HRV) indices (SDNN, RMSSD, LF/HF ratio).
- Endothelial function will be evaluated using flow-mediated dilation (FMD) of the brachial artery, analyzed via Cardiovascular Suite™ software to assess nitric oxide-dependent vasodilation.
Secondary outcomes include:
- Splanchnic hemodynamics: Changes in celiac and superior mesenteric artery (SMA) blood flow measured via mesenteric Doppler ultrasound (Vivid IQ, GE Healthcare). Time-averaged mean velocity (TAMV), vessel diameter, and blood flow will be recorded at baseline and post-intervention.
- Sarcopenia-related measures: Muscle mass (DEXA, BIA), muscle strength (handgrip dynamometry), and physical performance (6-minute walk test).
- Laboratory outcomes: Serum ammonia, liver function tests, fasting glucose, albumin, renal function, and coagulation profile.
- Correlative analyses: Associations between (a) muscle mass and serum ammonia, and (b) muscle mass and autonomic parameters (e.g., HRV indices).
Read the detailed description
An additional non-invasive assessment, Mesenteric Duplex Doppler Ultrasound, will be performed to evaluate mesenteric and portal blood flow as an exploratory parameter.
- Conditions
- Cirrhosis, Aerobic Exercises, Lifestyle Modification, Endothelial Function, Autonomic Nervous System, Autonomic Dysfunction
- Being tested
- Aerobic exercise + Nutrition consultant, Nutrition consultant
- Keywords
- Cirrhosis, Autonomic nervous system, Endothelial function, Aerobic exercise
- Medical subject headings
- Fibrosis, Primary Dysautonomias, Sarcopenia, Motor Activity, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic exercise + Nutrition consultantBehavioural
Also called Exercise group, Active group
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 consultantBehavioural
Also called diet
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Behavioral: Aerobic exercise + Nutrition consultant; Behavioral: Nutrition consultant |
| Control group | Other | The control group will solely receive nutritional guidance and maintain their physical inactivity. Receives: Behavioral: Nutrition consultant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time-domain Heart Rate Variability (HRV) Parameters: SDNN and RMSSD and SDANN
Heart rate variability (HRV) was assessed using a 15-minute resting ECG recording. This table reports three time-domain measures: 1) SDNN (Standard deviation of all NN intervals), 2) RMSSD (Root mean square of successive differences), and 3) SDANN (Standard deviation of the average NN intervals). These parameters reflect autonomic nervous system activity and cardiac vagal tone. All data are reported in milliseconds. Higher values indicate better autonomic regulation. Only these three time-domain parameters are presented in this table.
Measured: Change from Baseline (week 0) at Week 16
Time Domain Outcome: pNN50
A time-domain measure of heart rate variability (HRV) reflecting parasympathetic activity. It is calculated as the percentage of successive normal-to-normal (NN) intervals that differ by more than 50 milliseconds. Data were collected using 3-lead ECG during a 15-minute resting period."
Measured: Change from Baseline (week 0) at week 16
HRV Frequency Domain Measures: TP, HF, LF, VLF
Assessment of frequency-domain components of heart rate variability, including Total Power (TF), High Frequency (HF), Low Frequency (LF), and Very Low Frequency (VLF). Analysis was performed using Adinstrument (tm) on a 15-minute ECG recording at rest. These parameters reflect the power distribution across different frequency bands and represent autonomic nervous system activity. Data presented in the table represent the change from baseline to Week 16.
Measured: Change from Baseline (week 0) at Week 16
Changes in Ewing Autonomic Battery Test Scores (Improved, No Change, Worsened)
Categorical assessment of changes in autonomic function using the Ewing Autonomic Battery test. Participants are classified into three categories: 'Improved', 'No change', or 'Worsened' based on their composite score changes from baseline to Week 16. Results are reported as the number of participants in each category.
Measured: Change from Baseline (week 0) and Week 16
Endothelial Function Test: Change in Flow-mediated Dilation (FMD)
Assessment of the change in brachial artery flow-mediated dilation (FMD) from baseline to Week 16. FMD was determined by ultrasound as the percentage increase in arterial diameter during reactive hyperemia compared to baseline diameter. Results are reported as the percentage change (%). Positive values indicate an improvement in endothelial-dependent vasodilation.
Measured: Change from Baseline (week 0) at Week 16
HRV Frequency Domain Measures: Low Frequency/High Frequency (LF/HF) Ratio
The LF/HF ratio is calculated as the ratio between the absolute power of the Low Frequency (LF) and High Frequency (HF) bands. It is used as an index of sympathovagal balance. Results are reported as a ratio (unitless).
Measured: Change from baseline (week 0) to week 16
Secondary outcomes (5)
Muscle Mass Change
Lean appendicular mass (kg) from Dual energy X-ray absorptiometry (DXA)
Measured: Change from Baseline (week 0) at week 16
Physical Function
6-minute walk test (minute)
Measured: Change from Baseline (week 0) at week 16
Muscle Strength Change
Handgrip strength (kg) from dynamometer
Measured: Change from Baseline (week 0) at week 16
Splanchnic Volume Flow
Blood-flow parameters derived from mesenteric Doppler ultrasound (celiac and superior mesenteric arteries, portal vein) were obtained as exploratory markers of splanchnic circulation.
Measured: Baseline and after 16-week intervention
The Association Between Changes in Muscle Mass and Changes in Serum Ammonia Levels
Assessment of the correlation between the change in appendicular muscle mass index (measured by appendicular mass divided by height squared via Dual-Energy X-ray Absorptiometry; DXA) and the change in serum ammonia levels from baseline to week 16. Statistical significance is evaluated using Spearman's rank correlation coefficient for non-normally distributed data.
Measured: Baseline and Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2024
- Study start12 Mar 2024
- Primary completion15 Aug 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for CirrhosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Chulalongkorn Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Chulalongkorn University
- Responsible party
- Principal investigator, Sirinda Kittiprachakul, King Chulalongkorn Memorial Hospital
- Investigators
- Sirinda Kittiprachakul, Principal investigator, King Chulalongkorn Memorial
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06288828
- Sponsor's protocol ID
- IRB0569/66
- Status last verified
- May 2026
- First submitted
- 22 Feb 2024
- Last updated
- 22 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text,tables,figures, and appendices) will be provided with anyone who wishes to access the data. Study Protocol will also be provided with anyone who wishes to access the data. Information regarding submitting proposals and accessing data may be found at https://rehabmed.md.chula.ac.th/research/.
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy Of Aerobic Exercise Training On Autonomic Nervous System And Endothelial Function In Patients With Compensated Cirrhosis: A Parallel, RCT Study
- ClinicalTrials.gov ID
- NCT06288828
- Acronym / sponsor ID
- IRB0569/66
- Conditions
- Cirrhosis, Aerobic Exercises, Lifestyle Modification, Endothelial Function, Autonomic Nervous System, Autonomic Dysfunction
- Keywords
- Cirrhosis, Autonomic nervous system, Endothelial function, Aerobic exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- King Chulalongkorn Memorial HospitalUniversity, hospital or other
- Collaborators
- Chulalongkorn University
- Study start
- 12 Mar 2024 (actual)
- Primary completion
- 15 Aug 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 1 Mar 2024 (actual)
- Results
- Posted 22 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this randomized controlled trial is to investigate whether a 16-week structured aerobic exercise program combined with nutritional consultation can improve autonomic and endothelial function in patients with compensated cirrhosis.
Study Design:
This assessor-blinded, parallel-group randomized controlled trial will be conducted at King Chulalongkorn Memorial Hospital, Bangkok, Thailand. Fifty adults with compensated (Child-Pugh class A) cirrhosis will be recruited during routine hepatology clinic visits. Eligible participants are aged 45-75 years, have a sedentary lifestyle (<150 minutes of moderate or <75 minutes of vigorous physical activity per week), and have abstained from alcohol for at least six months.
Exclusion criteria include active or recently treated hepatocellular carcinoma (within three months), severe portal hypertension complications (untreated large varices, prior variceal bleeding, or severe gastropathy), transjugular intrahepatic portosystemic shunt (TIPS), unstable cardiac disease, orthopedic limitations, morbid obesity (BMI >35 kg/m²), or current use of alpha- or beta-blockers that affect autonomic function.
Intervention:
Participants will be randomly assigned to either the intervention or control group. Both groups will receive nutritional consultation and individualized dietary guidance at baseline, week 8, and week 16. Nutritional goals are set at 35 kcal/kg/day and 1.2 g/kg/day of protein intake. If targets are unmet, the dietitian will provide individualized recommendations to support adequate intake.
The intervention group will participate in a 16-week aerobic exercise program consisting of brisk walking at moderate intensity (50-70% of maximal heart rate), totaling 150 minutes per week. The program includes two phases:
- Phase 1 (Weeks 1-4): Combined hospital-based (1 session per week) and home-based exercise under physical therapist supervision, with gradual intensity titration.
- Phase 2 (Weeks 5-16): Fully home-based exercise following prescribed intensity and frequency, with weekly follow-up via telephone or messaging to monitor adherence, safety, and exercise log completion.
The control group will maintain their usual physical activity levels while receiving the same schedule of nutritional consultations and weekly follow-up for monitoring compliance and adverse events.
Outcomes:
Primary outcomes include changes in autonomic and endothelial function after 16 weeks.
- Autonomic function will be assessed using the Ewing autonomic battery test (HR response to standing, deep breathing, and Valsalva maneuver; BP response to posture and sustained handgrip) and heart rate variability (HRV) indices (SDNN, RMSSD, LF/HF ratio).
- Endothelial function will be evaluated using flow-mediated dilation (FMD) of the brachial artery, analyzed via Cardiovascular Suite™ software to assess nitric oxide-dependent vasodilation.
Secondary outcomes include:
- Splanchnic hemodynamics: Changes in celiac and superior mesenteric artery (SMA) blood flow measured via mesenteric Doppler ultrasound (Vivid IQ, GE Healthcare). Time-averaged mean velocity (TAMV), vessel diameter, and blood flow will be recorded at baseline and post-intervention.
- Sarcopenia-related measures: Muscle mass (DEXA, BIA), muscle strength (handgrip dynamometry), and physical performance (6-minute walk test).
- Laboratory outcomes: Serum ammonia, liver function tests, fasting glucose, albumin, renal function, and coagulation profile.
- Correlative analyses: Associations between (a) muscle mass and serum ammonia, and (b) muscle mass and autonomic parameters (e.g., HRV indices).
Detailed description
An additional non-invasive assessment, Mesenteric Duplex Doppler Ultrasound, will be performed to evaluate mesenteric and portal blood flow as an exploratory parameter.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise group | Experimental | Behavioral: Aerobic exercise + Nutrition consultant, Behavioral: Nutrition consultantParticipants 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). |
| Control group | Other | Behavioral: Nutrition consultantThe control group will solely receive nutritional guidance and maintain their physical inactivity. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic exercise + Nutrition consultantAlso: Exercise group, Active groupParticipants 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. | Behavioural | Exercise group |
| Nutrition consultantAlso: dietParticipants 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. | Behavioural | Control group, Exercise group |
Primary outcome
Time-domain Heart Rate Variability (HRV) Parameters: SDNN and RMSSD and SDANN
Time frame: Change from Baseline (week 0) at Week 16
Heart rate variability (HRV) was assessed using a 15-minute resting ECG recording. This table reports three time-domain measures: 1) SDNN (Standard deviation of all NN intervals), 2) RMSSD (Root mean square of successive differences), and 3) SDANN (Standard deviation of the average NN intervals). These parameters reflect autonomic nervous system activity and cardiac vagal tone. All data are reported in milliseconds. Higher values indicate better autonomic regulation. Only these three time-domain parameters are presented in this table.
Time Domain Outcome: pNN50
Time frame: Change from Baseline (week 0) at week 16
A time-domain measure of heart rate variability (HRV) reflecting parasympathetic activity. It is calculated as the percentage of successive normal-to-normal (NN) intervals that differ by more than 50 milliseconds. Data were collected using 3-lead ECG during a 15-minute resting period."
HRV Frequency Domain Measures: TP, HF, LF, VLF
Time frame: Change from Baseline (week 0) at Week 16
Assessment of frequency-domain components of heart rate variability, including Total Power (TF), High Frequency (HF), Low Frequency (LF), and Very Low Frequency (VLF). Analysis was performed using Adinstrument (tm) on a 15-minute ECG recording at rest. These parameters reflect the power distribution across different frequency bands and represent autonomic nervous system activity. Data presented in the table represent the change from baseline to Week 16.
Changes in Ewing Autonomic Battery Test Scores (Improved, No Change, Worsened)
Time frame: Change from Baseline (week 0) and Week 16
Categorical assessment of changes in autonomic function using the Ewing Autonomic Battery test. Participants are classified into three categories: 'Improved', 'No change', or 'Worsened' based on their composite score changes from baseline to Week 16. Results are reported as the number of participants in each category.
Endothelial Function Test: Change in Flow-mediated Dilation (FMD)
Time frame: Change from Baseline (week 0) at Week 16
Assessment of the change in brachial artery flow-mediated dilation (FMD) from baseline to Week 16. FMD was determined by ultrasound as the percentage increase in arterial diameter during reactive hyperemia compared to baseline diameter. Results are reported as the percentage change (%). Positive values indicate an improvement in endothelial-dependent vasodilation.
HRV Frequency Domain Measures: Low Frequency/High Frequency (LF/HF) Ratio
Time frame: Change from baseline (week 0) to week 16
The LF/HF ratio is calculated as the ratio between the absolute power of the Low Frequency (LF) and High Frequency (HF) bands. It is used as an index of sympathovagal balance. Results are reported as a ratio (unitless).
5 secondary outcomes
Muscle Mass Change
Time frame: Change from Baseline (week 0) at week 16
Physical Function
Time frame: Change from Baseline (week 0) at week 16
Muscle Strength Change
Time frame: Change from Baseline (week 0) at week 16
Splanchnic Volume Flow
Time frame: Baseline and after 16-week intervention
The Association Between Changes in Muscle Mass and Changes in Serum Ammonia Levels
Time frame: Baseline and Week 16
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text,tables,figures, and appendices) will be provided with anyone who wishes to access the data. Study Protocol will also be provided with anyone who wishes to access the data. Information regarding submitting proposals and accessing data may be found at https://rehabmed.md.chula.ac.th/research/.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sirinda Kittiprachakul principal investigator
King Chulalongkorn Memorial
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic exercise + Nutrition consultant and Nutrition consultant in people with Cirrhosis and Aerobic Exercises, run by King Chulalongkorn Memorial Hospital at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time-domain Heart Rate Variability (HRV) Parameters: SDNN and RMSSD and SDANN (time frame: Change from Baseline (week 0) at Week 16). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.