Feasibility of an App-based Nutrition & Exercise Program in Cirrhosis
Primary Purpose
Cirrhosis, Liver, Hepatic Encephalopathy
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Nutrition and Exercise app
Sponsored by
About this trial
This is an interventional treatment trial for Cirrhosis, Liver
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
Sites / Locations
- University of Alberta
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Nutrition and Exercise App
Arm Description
The 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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
6-MWT
The change in distance walked in 6 minutes.
Program Satisfaction
Self-reported satisfaction with the nutrition and exercise program.
Full Information
NCT ID
NCT05033327
First Posted
March 23, 2020
Last Updated
January 30, 2023
Sponsor
University of Alberta
Collaborators
Canadian National Transplant Research Program, Nutricia Foundation
1. Study Identification
Unique Protocol Identification Number
NCT05033327
Brief Title
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
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
April 20, 2021 (Actual)
Primary Completion Date
March 31, 2022 (Actual)
Study Completion Date
December 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Alberta
Collaborators
Canadian National Transplant Research Program, Nutricia Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cirrhosis, Liver, Hepatic Encephalopathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Pilot study
Masking
None (Open Label)
Allocation
N/A
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nutrition and Exercise App
Arm Type
Other
Arm Description
The 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.
Intervention Type
Behavioral
Intervention Name(s)
Nutrition and Exercise app
Other Intervention Name(s)
Heal-Me
Intervention Description
Personalized, home-based, interactive therapy app
Primary Outcome Measure Information:
Title
Participant Retention/Adherence
Description
The number of participants who complete the 12-week nutrition and exercise program and meet 70% of the nutrition and exercise goals.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
6-MWT
Description
The change in distance walked in 6 minutes.
Time Frame
12 weeks
Title
Program Satisfaction
Description
Self-reported satisfaction with the nutrition and exercise program.
Time Frame
12 weeks
Other Pre-specified Outcome Measures:
Title
Chair Sit-to-Stand
Description
The change in time required to complete 5x sit-to-stands from baseline to end of study.
Time Frame
12 weeks
Title
Thigh Muscle Measures
Description
The change in thigh muscle thickness and echogenicity from baseline to end of study.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Puneeta Tandon, MD
Organizational Affiliation
University of Alberta
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alberta
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2X8
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29964066
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.
Results Reference
background
PubMed Identifier
29738109
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.
Results Reference
background
PubMed Identifier
29072825
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.
Results Reference
background
PubMed Identifier
28361840
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.
Results Reference
background
PubMed Identifier
27539029
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.
Results Reference
background
PubMed Identifier
24768811
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.
Results Reference
background
Links:
URL
http://www.wellnesstoolbox.ca
Description
Study website
Learn more about this trial
Feasibility of an App-based Nutrition & Exercise Program in Cirrhosis
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