Feasibility of an App-based Nutrition & Exercise Program in Cirrhosis
The Acceptability of an App-based, Interactive, Personalized Nutrition and Exercise Program to Support Self-management in Cirrhosis: a Pilot Study
1 other identifier
interventional
27
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 23, 2020
CompletedStudy Start
First participant enrolled
April 20, 2021
CompletedFirst Posted
Study publicly available on registry
September 2, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedFebruary 1, 2023
January 1, 2023
12 months
March 23, 2020
January 30, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
6-MWT
12 weeks
Program Satisfaction
12 weeks
Other Outcomes (2)
Chair Sit-to-Stand
12 weeks
Thigh Muscle Measures
12 weeks
Study Arms (1)
Nutrition and Exercise App
OTHERThe exercise and nutrition app intervention will be provided to study participants. The app offers self-directed and supervised (virtual) programming to support nutrition and exercise self-management. Each participant follows a program that has been tailored to their overall health, physical function, and needs.
Interventions
Personalized, home-based, interactive therapy app
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Albertalead
- Canadian National Transplant Research Programcollaborator
- Nutricia Foundationcollaborator
Study Sites (1)
University of Alberta
Edmonton, Alberta, T6G 2X8, Canada
Related Publications (6)
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.
PMID: 29964066BACKGROUNDEslamparast 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.
PMID: 29738109BACKGROUNDMazurak VC, Tandon P, Montano-Loza AJ. Nutrition and the transplant candidate. Liver Transpl. 2017 Nov;23(11):1451-1464. doi: 10.1002/lt.24848.
PMID: 29072825BACKGROUNDNey 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.
PMID: 28361840BACKGROUNDNey 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.
PMID: 27539029BACKGROUNDZenith 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.
PMID: 24768811BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Puneeta Tandon, MD
University of Alberta
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 23, 2020
First Posted
September 2, 2021
Study Start
April 20, 2021
Primary Completion
March 31, 2022
Study Completion
December 31, 2022
Last Updated
February 1, 2023
Record last verified: 2023-01
Data Sharing
- IPD Sharing
- Will not share