Clinical trial NCT05033327: Feasibility of an App-based Nutrition & Exercise Program in Cirrhosis
Official title: The Acceptability of an App-based, Interactive, Personalized Nutrition and Exercise Program to Support Self-management in Cirrhosis: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cirrhosis, Liver
Hepatic Encephalopathy
Lead sponsor: University of Alberta
Sponsor class: OTHER
Collaborators: name: Canadian National Transplant Research Program
name: Nutricia Foundation
First posted: 2021-09-02
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pilot study
Primary purpose: TREATMENT

Brief summary: The personalized nutrition and exercise app was designed for use by individuals living with chronic conditions. The pilot study examines the acceptance and use of the online, interactive program to support self-management in cirrhosis.

Detailed description: Patients living with chronic disease are at-risk for frailty because of their potentially sedentary lifestyle and/or symptoms. Supervised exercise programs are useful for improving or maintaining physical capacity as measured by common physical function measures. However, accessibility is limited due to scheduling, transportation, employment, and residential location. Unsupervised, self-directed home-based programs have had limited success due to absence of peer support and accountability.

An alternative is an app-based program that offers interactive engagement with study staff and accountability. Further, follow-along videos and tracking for both nutrition and exercise can be completed at the patient's convenience.

A 12-week pilot study with patients living with cirrhosis will assess the acceptability of the programming. The hypothesis is that study participants will find the customization of the app and interaction with the study staff acceptable as measured by completion rates (primary study endpoint). Secondary outcomes include change in measures (0-12 weeks) for the 6-minute walk test (6MWT), thigh muscle thickness, and chair sit-to-stands. At the end of the study, participants will also complete a program satisfaction survey (developed in-house).

Interviews with participants, caregivers, and study staff, conducted via videoconference at 4-6 weeks and end of study, will be descriptively analysed to identify feasibility, acceptability, and perceived utility of the program. Analyses will also identify areas for program improvement.

Eligibility criteria: Inclusion Criteria:

* adult (aged 18 years and older)
* diagnosis of cirrhosis (MELD\<25) according to biopsy, imaging, elastography, or other
* fulfill the guideline-based prophylaxis in place for high risk gastroesophageal varices
* able to communicate (e.g., speak, read, and write) in English
* provide informed written consent for self

Exclusion Criteria:

* hepatocellular carcinoma (HCC) outside of the Edmonton liver transplant criteria
* previous myocardial infarction
* EF \<50%
* ischemia on stress testing
* oxygen saturation \<95%
* non-HCC malignancy
* end-stage renal disease.
* at the discretion of the healthcare team if a participant can participate in the pilot study

Primary outcomes:
measure: Participant Retention/Adherence
timeFrame: 12 weeks
Secondary outcomes:
measure: 6-MWT
timeFrame: 12 weeks
measure: Program Satisfaction
timeFrame: 12 weeks
Other outcomes:
measure: Chair Sit-to-Stand
timeFrame: 12 weeks
measure: Thigh Muscle Measures
timeFrame: 12 weeks
Locations:
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
Study officials:
affiliation: University of Alberta
name: Puneeta Tandon, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tandon P, Ismond KP, Riess K, Duarte-Rojo A, Al-Judaibi B, Dunn MA, Holman J, Howes N, Haykowsky MJF, Josbeno DA, McNeely M. Exercise in cirrhosis: Translating evidence and experience to practice. J Hepatol. 2018 Nov;69(5):1164-1177. doi: 10.1016/j.jhep.2018.06.017. Epub 2018 Jun 30.
citation: Eslamparast T, Montano-Loza AJ, Raman M, Tandon P. Sarcopenic obesity in cirrhosis-The confluence of 2 prognostic titans. Liver Int. 2018 Oct;38(10):1706-1717. doi: 10.1111/liv.13876. Epub 2018 May 25.
citation: Mazurak VC, Tandon P, Montano-Loza AJ. Nutrition and the transplant candidate. Liver Transpl. 2017 Nov;23(11):1451-1464. doi: 10.1002/lt.24848.
citation: Ney M, Gramlich L, Mathiesen V, Bailey RJ, Haykowsky M, Ma M, Abraldes JG, Tandon P. Patient-perceived barriers to lifestyle interventions in cirrhosis. Saudi J Gastroenterol. 2017 Mar-Apr;23(2):97-104. doi: 10.4103/1319-3767.203357.
citation: Ney M, Haykowsky MJ, Vandermeer B, Shah A, Ow M, Tandon P. Systematic review: pre- and post-operative prognostic value of cardiopulmonary exercise testing in liver transplant candidates. Aliment Pharmacol Ther. 2016 Oct;44(8):796-806. doi: 10.1111/apt.13771. Epub 2016 Aug 19.
citation: Zenith L, Meena N, Ramadi A, Yavari M, Harvey A, Carbonneau M, Ma M, Abraldes JG, Paterson I, Haykowsky MJ, Tandon P. Eight weeks of exercise training increases aerobic capacity and muscle mass and reduces fatigue in patients with cirrhosis. Clin Gastroenterol Hepatol. 2014 Nov;12(11):1920-6.e2. doi: 10.1016/j.cgh.2014.04.016. Epub 2014 Apr 24.