Background:
Cirrhosis is a systemic disease that impairs muscle health, defined by international guidelines as poor muscle mass, quality, and function, in approximately 41% of patients. Poor muscle health in cirrhosis is strongly associated with impaired quality of life, increased healthcare utilization, liver-related decompensation events, and mortality. Older adults (≥65 years) with cirrhosis are particularly vulnerable due to synergistic effects of both aging- and liver-related muscle loss.
Study design:
This is a prospective, randomized, double-blind, placebo-controlled, two-arm pilot feasibility study.
Study Arms:
- Treatment Arm A: HEAL-ME digital program + placebo supplementation (once daily for 12 weeks)
- Treatment Arm B: HEAL-ME digital program + creatine (5g) + whey protein (35g) supplementation (once daily for 12 weeks)
Study Schema:
Study Duration:
- Total Study Duration: 12 months
- Recruitment Period: Approximately 28 weeks (~1 participant/week)
- Intervention Duration: 12 weeks per participant
- Follow-up: End of intervention (Week 12)
- Data Analysis Period: Months 10-12