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Changes in hepatic venous pressure gradient induced by physical exercise in cirrhosis: results of a pilot randomized open clinical trial [with consumer summary]
Macias-Rodriguez RU, Ilarraza-Lomeli H, Ruiz-Margain A, Ponce-de-Leon-Rosales S, Vargas-Vorackova F, Garcia-Flores O, Torre A, Duarte-Rojo A
Clinical and Translational Gastroenterology 2016 Jul 14;7(7):e180
clinical trial
8/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

OBJECTIVES: Exercise has been scarcely studied in patients with cirrhosis, and prior evidence showed hepatic venous pressure gradient (HVPG) to be increased in response to exercise. The aim of this study was to investigate the effects of a supervised physical exercise program (PEP) in patients with cirrhosis. METHODS: In an open-label, pilot clinical trial, patients with cirrhosis were randomized to PEP (cycloergometry/kinesiotherapy plus nutritional therapy, n = 14) or control (nutritional therapy, n = 15); for 14 weeks. Primary outcomes were: the effect of PEP in HVPG, and quality of life (chronic liver disease questionnaire, CLDQ). As secondary outcomes we investigated changes in physical fitness (cardiopulmonary exercise testing), nutritional status (phase angle-bioelectrical impedance), ammonia levels, and safety. RESULTS: Twenty-two patients completed the study (11 each). HVPG decreased in subjects allocated to PEP (-2.5 mmHg (interquartile range -5.25 to 2); p = 0.05), and increased in controls (4 mmHg (0 to 5); p = 0.039), with a significant between-groups difference (p = 0.009). No major changes were noted in CLDQ in both groups. There was significant improvement in ventilatory efficiency (VE/VCO2) in PEP group (-1.9 (-3.12 to -0.1); p = 0.033), but not in controls (-0.4 (-5.7 to 1.4); p = 0.467). Phase angle improvement and a less-pronounced exercise-induced hyperammonemia were noted only in PEP group. No episodes of variceal bleeding or hepatic encephalopathy were observed. CONCLUSIONS: A supervised PEP in patients with cirrhosis decreases the HVPG and improves nutritional status with no changes in quality of life. Further studies evaluating physical training in cirrhosis are eagerly awaited in order to better define the benefits of sustained exercise. ClinicalTrials.gov NCT00517738.

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