Feasibility of an App-based Nutrition & Exercise Program in Cirrhosis

Cirrhosis, Liver Clinical Trial

Official title:

The Acceptability of an App-based, Interactive, Personalized Nutrition and Exercise Program to Support Self-management in Cirrhosis: a Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05033327
• Other study ID #: Pro00087451
• Status: Completed
• Phase: N/A
• Start date: April 20, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: January 2023
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: December 31, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Diseases
• Cirrhosis, Liver
• Fibrosis
• Hepatic Encephalopathy
• Liver Cirrhosis

Intervention

Behavioral:
• Nutrition and Exercise app
Personalized, home-based, interactive therapy app

Locations

Country	Name	City	State
Canada	University of Alberta	Edmonton	Alberta

Sponsors (3)

Lead Sponsor	Collaborator
University of Alberta	Canadian National Transplant Research Program, Nutricia Foundation

Country where clinical trial is conducted

Canada, 

References & Publications (6)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Chair Sit-to-Stand	The change in time required to complete 5x sit-to-stands from baseline to end of study.	12 weeks
Other	Thigh Muscle Measures	The change in thigh muscle thickness and echogenicity from baseline to end of study.	12 weeks
Primary	Participant Retention/Adherence	The number of participants who complete the 12-week nutrition and exercise program and meet 70% of the nutrition and exercise goals.	12 weeks
Secondary	6-MWT	The change in distance walked in 6 minutes.	12 weeks
Secondary	Program Satisfaction	Self-reported satisfaction with the nutrition and exercise program.	12 weeks

External Links

•   Study website