Trial Outcomes & Findings for The Efficacy of Aerobic Exercise Training on ANS and Endothelial Function in Compensated Cirrhosis (NCT NCT06288828)

Participants were recruited from patients attending the Liver Unit of the Division of Gastroenterology, Department of Medicine, at King Chulalongkorn Memorial Hospital. The recruitment period spanned from March 12, 2024, to June 30, 2025.

A total of 525 patients who visited the Liver Unit, Division of Gastroenterology, at King Chulalongkorn Memorial Hospital were screened for eligibility. Potential participants were evaluated based on the inclusion and exclusion criteria. Of those screened, 475 patients were excluded prior to randomization: 303 did not meet the specific study criteria, and 172 declined to participate in the study for personal reasons or lack of interest in the intervention

Assessment of body composition parameters via Bioelectrical Impedance Analysis (BIA) and Dual-energy X-ray Absorptiometry (DXA).

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.

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."

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.

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.

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.

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).

Lean appendicular mass (kg) from Dual energy X-ray absorptiometry (DXA)

6-minute walk test (minute)

Handgrip strength (kg) from dynamometer

Blood-flow parameters derived from mesenteric Doppler ultrasound (celiac and superior mesenteric arteries, portal vein) were obtained as exploratory markers of splanchnic circulation.

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.