A Multicenter Pilot Randomized Clinical Trial of a Home-Based Exercise Program for Patients With Cirrhosis: The Strength Training Intervention (STRIVE)

Abstract

INTRODUCTION We developed the strength training intervention (STRIVE), a home-based exercise program targeting physical function in patients with cirrhosis. In this pilot study, we aimed to evaluate the safety and efficacy of STRIVE. METHODS Eligible were adult patients with cirrhosis at 3 sites. Patients were randomized 2:1–12 weeks of STRIVE, a 30-minute strength training video plus a health coach or standard of care (SOC). Physical function and quality of life were assessed using the Liver Frailty Index (LFI) and Chronic Liver Disease Questionnaire (CLDQ), respectively. RESULTS Fifty-eight and 25 were randomized to STRIVE and SOC arms, respectively: 43% women, median age was 61 years, MELDNa, Model for End-Stage Liver Disease Sodium was 14, and 54% were Child-Pugh B/C. Baseline characteristics were similar in the STRIVE vs SOC arms except for rates of hepatic encephalopathy (19 vs 36%). LFI @ 12 weeks was available in 43 STRIVE and 20 SOC participants. After 12 weeks, the median LFI improved from 3.8 to 3.6 (ΔLFI −0.1) in the STRIVE arm and 3.7 to 3.6 (ΔLFI −0.1) in the SOC arm (P = 0.65 for ΔLFI difference). CLDQ scores improved from 4.6 to 5.2 in STRIVE participants (ΔCLDQ 0.38) and did not change in SOC participants (4.2–4.2; ΔCLDQ −0.03) (P = 0.09 for ΔCLDQ difference). One patient died (SOC arm) of bleeding. Only 14% of STRIVE participants adhered to the strength training video for 10–12 weeks. No adverse events were reported by STRIVE participants. DISCUSSION STRIVE, a home-based structured exercise program for patients with cirrhosis, was safely administered at 3 sites, but adherence was low. Although all participants showed minimal improvement in the LFI, STRIVE was associated with a substantial improvement in quality of life.

Impact of a Pilot Structured Mobile Technology Based Lifestyle Intervention for Patients with Nonalcoholic Fatty Liver Disease

“…Among the 33 participants who completed the program, the median percentage of days with valid FitBit data collection was 91%. Our rates of adherence using the fitness activity tracker are higher than those reported in other physical activity intervention trials including the recent STRIVE trial of a home-based exercise program among individuals with cirrhosis [20]. This is likely related to variations in definition for adherence, study design features for follow-up among participants with patterns indicating low adherence, and patient population enrolled.…”

Malnutrition, Frailty, and Sarcopenia in Patients With Cirrhosis: 2021 Practice Guidance by the American Association for the Study of Liver Diseases

“…This article is protected by copyright. All rights reserved [78][79][80][81]238,[262][263][264][265] The caveat to interpretation of these studies in this population is they have been limited by small sample size and inclusion of primarily well-compensated patients.…”

“…Physical activity-based interventions have been shown to improve muscle contractile function and muscle mass as well as cardiopulmonary function and quality of life in patients with cirrhosis. (78)(79)(80)(81)238,(262)(263)(264)(265) The caveat to interpretation of these studies in this population is that they have been limited by small sample size and inclusion of primarily well-compensated patients.…”

Randomised Clinical Trial: Effect of Adding Branched Chain Amino Acids to Exercise and Standard-of-care on Muscle Mass in Cirrhotic Patients With Sarcopenia

“…However, similar and even lower adherence for home based exercise regimens have been reported in previous larger trials and the higher adherence in our study could be due to telephonic reminders and visual aid provided to the patient. 41 To conclude, this trial demonstrates that addition of BCAA to exercise and adequate dietary intake does not improve muscle mass, functional measures of sarcopenia or quality of life in patients with cirrhosis with sarcopenia. Further trials may be useful to assess if any subgroup of patients may bene t, especially Child C patients as they have the highest short-term mortality and prevalence of sarcopenia.…”