A pilot clinical trial of exercise program for elderly patients with cirrhosis and frailty: comprehensive exercise rehabilitation intervention

BACKGROUND AND AIM: Comprehensive exercise rehabilitation has the potential to increase muscle mass and performance by stimulating protein synthesis and accelerating muscle catabolism. We developed the comprehensive exercise rehabilitation intervention (CERI) for elderly patients with cirrhosis, and we aimed to evaluate the safety and efficacy of CERI. METHODS: Eligible were elderly patients with cirrhosis and frailty. Patients were randomized 1 : 1 to 12 weeks of CERI. Physical function were assessed using the gait speed, grip strength, 5 Sit-down Tests, and Balance Test, respectively. RESULTS: Finally, 58 and 58 completed the study in CERI and SOC arms, respectively. The age range is 60-73. After 12 weeks, gait speed improved from 0.89 to 1.06 in CERI participants (Δgait speed 0.17) and 0.87-0.91 (Δgait speed 0.04) in SOC arm ( P = 0.001 for Δgait speed difference). Grip strength improved from 15.44 to 15.94 in CERI participants (Δgrip strength 0.50) and 15.52-15.16 (Δgrip strength -0.36) in SOC arm ( P = 0.044 for Δgrip strength difference). 5 Sit-down Tests Score improved from 16.17 to 15.46 in CERI participants (Δ5 Sit-down Tests 0.71) and 16.78-16.61 (Δ5 Sit-down Tests 0.17) in SOC arm ( P = 0.037 for Δ5 Sit-down Tests difference). Median Balance Test score improved from 26.11 to 28.82 in CERI participants (ΔBalance Test 2.71) and 25.94-26.13 (ΔBalance Test 0.19) in SOC arm ( P < 0.001 for ΔBalance Test difference); 92% of CERI participants adhered to the study for 12 weeks. No adverse events were reported by CERI participants. CONCLUSION: CERI was safely administered at pilot randomized clinical trial, while all participants showed minimal improvement in gait speed, grip strength, 5 Sit-down Tests, and Balance Test. But multicenter, larger sample clinical trials are needed to track the effects of CERI.