Date: Saturday, May 30, 2020
Session Time: 3:15pm-4:45pm
Presentation Time: 3:15pm-3:27pm
*Purpose: Patients with cirrhosis experience progressive physical frailty and functional decline that may ultimately lead to an increased risk of death. We developed the Strength Training Intervention (STRIVE), a home-based exercise program targeting physical function in patients with cirrhosis. In this study, we aimed to test the real-world feasibility of administering STRIVE.
*Methods: Adult patients with cirrhosis awaiting liver transplantation at 3 sites (UCSF n=62, JHMI n=12, Duke n=9) with home internet or smart phone access were eligible; excluded were those with a variceal bleed within the last 3 months. Patients were randomized 2:1 [STRIVE:enhanced standard-of-care (SOC)] after providing informed consent. STRIVE consisted a 30-minute strength training video with resistance bands 3x/week, and weekly health coach phone calls for 12 weeks. The SOC arm consisted of an exercise handout based on national activity guidelines for older adults. All participants received a Fitbit for monitoring of their daily steps. Liver Frailty Index (LFI), as a metric of physical function, and Chronic Liver Disease Questionnaire (CLDQ), as a metric of quality of life, was assessed at baseline and 12 weeks.
*Results: 83 participants were enrolled: 58 and 25 were randomized to STRIVE and to the SOC arms, respectively: 43% women, 83% White, median age 61y. Median (IQR) MELDNa was 14 (11-19); 46%/46%/7% were Child A/B/C. There were no differences in baseline characteristics by arm. Average daily step count over 12 weeks was higher in STRIVE vs. SOC participants (4451 vs. 3569; p=0.37). LFI @ 12 weeks was available in 43 STRIVE and 20 SOC participants; baseline characteristics between those who did vs. did not have a 12 week assessment were similar except for % with hepatocellular carcinoma (44 vs. 20%) . After 12 weeks, median LFI improved from 3.76 to 3.62 (ΔLFI -0.07) in the STRIVE arm and 3.70 to 3.55 (ΔLFI -0.14) in SOC arm (p=0.65 for ΔLFI difference). CLDQ scores improved from 4.59 to 5.24 in STRIVE participants (ΔCLDQ 0.38) and worsened from 4.22 to 4.17 (ΔCLDQ -0.03) in SOC participants (p=0.09 for ΔCLDQ difference). Over 12 weeks, 1 patient died (SOC arm) of bleeding. No adverse events related to the intervention were reported.
*Conclusions: STRIVE, a home-based structured exercise program for patients with cirrhosis, was feasibly and safely administered at 3 sites. While all participants showed mild improvement in LFI, STRIVE was associated with a higher daily step count and substantial improvement in quality of life. These data are essential foundational data for the development of future interventions targeting physical frailty—and ultimately, mortality—in patients with cirrhosis.
To cite this abstract in AMA style:Lai JC, Kappus MR, Dodge JL, Wong R, Mohamad Y, Segev DL, McAdams-DeMarco MA. A Multi-Center Pilot and Feasibility Randomized Clinical Trial of a Home-Based Exercise Program for Patients with Cirrhosis: The Strength Training Intervention [abstract]. Am J Transplant. 2020; 20 (suppl 3). https://atcmeetingabstracts.com/abstract/a-multi-center-pilot-and-feasibility-randomized-clinical-trial-of-a-home-based-exercise-program-for-patients-with-cirrhosis-the-strength-training-intervention/. Accessed October 27, 2020.
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