| Primary | 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. | All participants who underwent randomization were included in the final analysis according to the modified Intention-to-Treat (ITT) principle. | Posted | May 2026 | Median | Inter-Quartile Range | milliseconds | | Change from Baseline (week 0) at Week 16 | | | | ID | Title | Description |
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| OG000 | Aerobic Exercise Group (AE) | 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). | | OG001 | Control Group (CG) | The control group will solely receive nutritional guidance and maintain their physical inactivity. |
| | | Title | Denominators | Categories |
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| SDNN | | | Title | Measurements |
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| - OG00075.87(32.55 to 117.31)
- OG00155.13(42.14 to 137.86)
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| | SDANN | | |
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| This analysis refers to the between-group comparison for SDNN. | Wilcoxon (Mann-Whitney) | | 0.64 | | Median of all pairwise differences | 6.99 | | | | | | | | | The estimated value represents the Hodges-Lehmann median difference between groups, which accounts for the distribution of all pairwise observations and may differ from the simple subtraction of group medians. | | Superiority | | | |
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| Primary | 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." | | Posted | | Median | Inter-Quartile Range | percentage of successive NN intervals | | Change from Baseline (week 0) at week 16 | | | | ID | Title | Description |
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| OG000 | Aerobic Exercise Group (AE) | 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). | | OG001 | Control Group (CG) | The control group will solely receive nutritional guidance and maintain their physical inactivity. |
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| Secondary | Muscle Mass Change | Lean appendicular mass (kg) from Dual energy X-ray absorptiometry (DXA) | | Posted | | Mean | Standard Deviation | kg | | Change from Baseline (week 0) at week 16 | | | | ID | Title | Description |
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| OG000 | Aerobic Exercise Group (AE) | Participants in this group began the study with an initial enrollment of 25 individuals. Of these, 23 participants successfully completed the 16-week supervised exercise program. Two participants were withdrawn during the study period: one was lost to follow-up (could not be contacted), and one was excluded due to an intercurrent event (new-onset atrial fibrillation). The intervention consisted of 150 minutes per week of brisk walking at a moderate intensity (RPE 12-15), designed to improve cardiovascular fitness and autonomic function. During the initial four weeks, the program followed a hybrid model-combining once-weekly hospital-based sessions with home-based exercise-followed by 12 weeks of exclusively home-based sessions. Additionally, participants received individualized dietary counseling at baseline, week 8, and upon study completion. These nutritional recommendations were aimed at meeting daily energy and protein targets of 35 kcal/kg and 1.2 g/kg of body weight, respectively. Clinical assessments-including Heart Rate Variability (HRV), the Ewing battery, Flow-Mediated Dilation (FMD), and splanchnic circulation parameters-were performed at baseline and at the conclusion of the 16-week period. | | OG001 | Control Group (CG) | Participants in this group began the study with an initial enrollment of 25 individuals. Of these, 21 participants successfully completed the 16-week study period. Four participants were withdrawn: three declined further follow-up (withdrawal by subject), and one was excluded due to an intercurrent event (anemia). Participants received standard medical care for compensated cirrhosis and were instructed to maintain their usual physical activity levels throughout the 16-week period. No structured or supervised exercise intervention was provided. To ensure consistency between groups, participants also received individualized dietary counseling at baseline, week 8, and upon study completion. These nutritional recommendations targeted a daily energy intake of 35 kcal/kg and a protein intake of 1.2 g/kg of body weight. Clinical assessments-including Heart Rate Variability (HRV), the Ewing battery, Flow-Mediated Dilation (FMD), and splanchnic circulation parameters-were performed at baseline and at the conclusion of the 16-week period. |
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| Secondary | Physical Function | 6-minute walk test (minute) | | Posted | | Median | Inter-Quartile Range | meter | | Change from Baseline (week 0) at week 16 | | | | ID | Title | Description |
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| OG000 | Aerobic Exercise Group (AE) | Participants in this group began the study with an initial enrollment of 25 individuals. Of these, 23 participants successfully completed the 16-week supervised exercise program. Two participants were withdrawn during the study period: one was lost to follow-up (could not be contacted), and one was excluded due to an intercurrent event (new-onset atrial fibrillation). The intervention consisted of 150 minutes per week of brisk walking at a moderate intensity (RPE 12-15), designed to improve cardiovascular fitness and autonomic function. During the initial four weeks, the program followed a hybrid model-combining once-weekly hospital-based sessions with home-based exercise-followed by 12 weeks of exclusively home-based sessions. Additionally, participants received individualized dietary counseling at baseline, week 8, and upon study completion. These nutritional recommendations were aimed at meeting daily energy and protein targets of 35 kcal/kg and 1.2 g/kg of body weight, respectively. Clinical assessments-including Heart Rate Variability (HRV), the Ewing battery, Flow-Mediated Dilation (FMD), and splanchnic circulation parameters-were performed at baseline and at the conclusion of the 16-week period. | | OG001 | Control Group (CG) | Participants in this group began the study with an initial enrollment of 25 individuals. Of these, 21 participants successfully completed the 16-week study period. Four participants were withdrawn: three declined further follow-up (withdrawal by subject), and one was excluded due to an intercurrent event (anemia). Participants received standard medical care for compensated cirrhosis and were instructed to maintain their usual physical activity levels throughout the 16-week period. No structured or supervised exercise intervention was provided. To ensure consistency between groups, participants also received individualized dietary counseling at baseline, week 8, and upon study completion. These nutritional recommendations targeted a daily energy intake of 35 kcal/kg and a protein intake of 1.2 g/kg of body weight. Clinical assessments-including Heart Rate Variability (HRV), the Ewing battery, Flow-Mediated Dilation (FMD), and splanchnic circulation parameters-were performed at baseline and at the conclusion of the 16-week period. |
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| Secondary | Muscle Strength Change | Handgrip strength (kg) from dynamometer | | Posted | | Mean | Standard Deviation | Kg | | Change from Baseline (week 0) at week 16 | | | | ID | Title | Description |
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| OG000 | 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). | | OG001 | Control Group | The control group will solely receive nutritional guidance and maintain their physical inactivity. |
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| Secondary | 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. | | Posted | May 2026 | Mean | Standard Deviation | mL/min | | Baseline and after 16-week intervention | | | | ID | Title | Description |
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| OG000 | Aerobic Exercise Group (AE) | Participants in this group began the study with an initial enrollment of 25 individuals. Of these, 23 participants successfully completed the 16-week supervised exercise program. Two participants were withdrawn during the study period: one was lost to follow-up (could not be contacted), and one was excluded due to an intercurrent event (new-onset atrial fibrillation). The intervention consisted of 150 minutes per week of brisk walking at a moderate intensity (RPE 12-15), designed to improve cardiovascular fitness and autonomic function. During the initial four weeks, the program followed a hybrid model-combining once-weekly hospital-based sessions with home-based exercise-followed by 12 weeks of exclusively home-based sessions. Additionally, participants received individualized dietary counseling at baseline, week 8, and upon study completion. These nutritional recommendations were aimed at meeting daily energy and protein targets of 35 kcal/kg and 1.2 g/kg of body weight, respectively. Clinical assessments-including Heart Rate Variability (HRV), the Ewing battery, Flow-Mediated Dilation (FMD), and splanchnic circulation parameters-were performed at baseline and at the conclusion of the 16-week period. | | OG001 | Control Group (CG) |
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| Primary | 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. | | Posted | | Median | Inter-Quartile Range | ms^2 | | Change from Baseline (week 0) at Week 16 | | | | ID | Title | Description |
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| OG000 | 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). | | OG001 | Control Group | The control group will solely receive nutritional guidance and maintain their physical inactivity. |
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| Primary | 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. | | Posted | | Count of Participants | | Participants | | Change from Baseline (week 0) and Week 16 | | | | ID | Title | Description |
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| OG000 | 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). | | OG001 | Control Group | The control group will solely receive nutritional guidance and maintain their physical inactivity. |
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| Primary | 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. | | Posted | | Mean | Standard Deviation | % of FMD response | | Change from Baseline (week 0) at Week 16 | | | | ID | Title | Description |
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| OG000 | 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). | | OG001 | Control Group | The control group will solely receive nutritional guidance and maintain their physical inactivity. |
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| Primary | 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). | | Posted | | Median | Inter-Quartile Range | Ratio | | Change from baseline (week 0) to week 16 | | | | ID | Title | Description |
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| OG000 | Aerobic Exercise Group (AE) | Participants in this group began the study with an initial enrollment of 25 individuals. Of these, 23 participants successfully completed the 16-week supervised exercise program. Two participants were withdrawn during the study period: one was lost to follow-up (could not be contacted), and one was excluded due to an intercurrent event (new-onset atrial fibrillation). The intervention consisted of 150 minutes per week of brisk walking at a moderate intensity (RPE 12-15), designed to improve cardiovascular fitness and autonomic function. During the initial four weeks, the program followed a hybrid model-combining once-weekly hospital-based sessions with home-based exercise-followed by 12 weeks of exclusively home-based sessions. Additionally, participants received individualized dietary counseling at baseline, week 8, and upon study completion. These nutritional recommendations were aimed at meeting daily energy and protein targets of 35 kcal/kg and 1.2 g/kg of body weight, respectively. Clinical assessments-including Heart Rate Variability (HRV), the Ewing battery, Flow-Mediated Dilation (FMD), and splanchnic circulation parameters-were performed at baseline and at the conclusion of the 16-week period. | | OG001 |
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| Secondary | 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. | | Posted | | Number | | Correlation coefficient | | Baseline and Week 16 | | | | ID | Title | Description |
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| OG000 | 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). | | OG001 | Control Group | The control group will solely receive nutritional guidance and maintain their physical inactivity. |
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