Cirrhosis, LiverNCT05033327
Feasibility of an App-based Nutrition & Exercise Program in Cirrhosis
A study testing Nutrition and Exercise app in people with Cirrhosis, Liver and Hepatic Encephalopathy, run by University of Alberta at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cirrhosis, Liver, Hepatic Encephalopathy
- What is being tested?
- Nutrition and Exercise app
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteCanada
- Study dates
- 20 Apr 2021to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Acceptability of an App-based, Interactive, Personalized Nutrition and Exercise Program to Support Self-management in Cirrhosis: a Pilot Study
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.
Read the 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.
- Conditions
- Cirrhosis, Liver, Hepatic Encephalopathy
- Being tested
- Nutrition and Exercise app
- Medical subject headings
- Liver Cirrhosis, Hepatic Encephalopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrition and Exercise appBehavioural
Also called Heal-Me
Personalized, home-based, interactive therapy app
| Study group | Role | What they receive |
|---|---|---|
| Nutrition and Exercise App | Other | 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. Receives: Behavioral: Nutrition and Exercise app |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (2)
6-MWT
The change in distance walked in 6 minutes.
Measured: 12 weeks
Program Satisfaction
Self-reported satisfaction with the nutrition and exercise program.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2021
- Study start20 Apr 2021
- Primary completion31 Mar 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Cirrhosis, LiverStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pilot study
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian National Transplant Research Program, Nutricia Foundation
- Responsible party
- Sponsor
- Investigators
- Puneeta Tandon, MD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05033327
- Sponsor's protocol ID
- Pro00087451
- Status last verified
- Jan 2023
- First submitted
- 23 Mar 2020
- Last updated
- 1 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29964066Eslamparast 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.
PubMed 29738109Mazurak VC, Tandon P, Montano-Loza AJ. Nutrition and the transplant candidate. Liver Transpl. 2017 Nov;23(11):1451-1464. doi: 10.1002/lt.24848.
PubMed 29072825Ney 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.
PubMed 28361840Ney 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.
PubMed 27539029Zenith 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.
PubMed 24768811Ismond KP, McNeely ML, Spence JC, Spiers JA, Tandon P. Initial participant perspectives about participating in an online, semi-supervised, cirrhosis-specific nutrition and exercise intervention. Br J Health Psychol. 2025 Feb;30(1):e12769. doi: 10.1111/bjhp.12769.
PubMed 39624948
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Acceptability of an App-based, Interactive, Personalized Nutrition and Exercise Program to Support Self-management in Cirrhosis: a Pilot Study
- ClinicalTrials.gov ID
- NCT05033327
- Acronym / sponsor ID
- Pro00087451
- Conditions
- Cirrhosis, Liver, Hepatic Encephalopathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- Canadian National Transplant Research Program, Nutricia Foundation
- Study start
- 20 Apr 2021 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 2 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pilot study
| Arm | Type | Receives |
|---|---|---|
| Nutrition and Exercise App | Other | Behavioral: Nutrition and Exercise appThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- hepatocellular carcinoma (HCC) outside of the Edmonton liver transplant criteria
- previous myocardial infarction
- EF <50%
- ischemia on stress testing
- oxygen saturation <95%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutrition and Exercise appAlso: Heal-MePersonalized, home-based, interactive therapy app | Behavioural | Nutrition and Exercise App |
Primary outcome
Participant Retention/Adherence
Time frame: 12 weeks
The number of participants who complete the 12-week nutrition and exercise program and meet 70% of the nutrition and exercise goals.
2 secondary outcomes
6-MWT
Time frame: 12 weeks
Program Satisfaction
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2023.
- Background: PubMed 29964066Tandon 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.
- Background: PubMed 29738109Eslamparast 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.
- Background: PubMed 29072825Mazurak VC, Tandon P, Montano-Loza AJ. Nutrition and the transplant candidate. Liver Transpl. 2017 Nov;23(11):1451-1464. doi: 10.1002/lt.24848.
- Background: PubMed 28361840Ney 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.
- Background: PubMed 27539029Ney 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.
- Background: PubMed 24768811Zenith 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.
- Derived from this study: PubMed 39624948Ismond KP, McNeely ML, Spence JC, Spiers JA, Tandon P. Initial participant perspectives about participating in an online, semi-supervised, cirrhosis-specific nutrition and exercise intervention. Br J Health Psychol. 2025 Feb;30(1):e12769. doi: 10.1111/bjhp.12769.
- Study websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Puneeta Tandon, MD principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutrition and Exercise app in people with Cirrhosis, Liver and Hepatic Encephalopathy, run by University of Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant Retention/Adherence (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05033327, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2023.