Strength training intervention with creatine/whey protein supplementation vs placebo on frailty in older adults with cirrhosis (STRIVE): A Randomized Controlled Trial
Abstract
Abstract Background Older adults with cirrhosis are particularly vulnerable to developing frailty with poor outcomes including increased falls, physical disability, hospitalizations, and all-cause mortality. Current management of frailty among older adults with cirrhosis is limited to general lifestyle recommendations including increased exercise and optimized diet, and few studies examining exercise interventions include patients with Child Pugh Class B or C. Whey protein and creatine are well-studied supplements commonly used to improve physical performance in athletes and have recently demonstrated positive effect in muscle mass among older adults but have not been studied in patients with cirrhosis. Therefore, we aimed to evaluate the effect of creatine/whey protein supplementation on frailty in older adults with cirrhosis (Child Pugh Class A, B, C) engaged in Strength Training Intervention (STRIVE), a semi-supervised program practicing exercise, nutrition, and life skills. Methods This study is a randomized, placebo-controlled trial including older adults (≥ 60 years) with cirrhosis evaluated at a single health center. We will recruit 200 patients informed by sample size calculations. Patients will be randomized 1:1, stratified by Child Pugh Class and gender. Participants who meet eligibility criteria will be automatically enrolled in a 2-week “ramp-up” period to assess engagement in the exercise portion of STRIVE prior to full enrollment into the 12-week study (STRIVE…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 200 participants or records.
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