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

November 25, 2022 updated by: University of Alberta

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

27

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2X8
        • University of Alberta

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Nutrition and Exercise App
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.
Behavioral: Nutrition and Exercise app
Personalized, home-based, interactive therapy app
Other Names:
  • Heal-Me

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
6-MWT
Time Frame: 12 weeks
The change in distance walked in 6 minutes.
12 weeks
Program Satisfaction
Time Frame: 12 weeks
Self-reported satisfaction with the nutrition and exercise program.
12 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Chair Sit-to-Stand
Time Frame: 12 weeks
The change in time required to complete 5x sit-to-stands from baseline to end of study.
12 weeks
Thigh Muscle Measures
Time Frame: 12 weeks
The change in thigh muscle thickness and echogenicity from baseline to end of study.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alberta

Collaborators

Nutricia Foundation
Canadian National Transplant Research Program

Investigators

  • Principal Investigator: Puneeta Tandon, MD, University of Alberta

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 20, 2021

Primary Completion (Actual)

March 31, 2022

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

March 23, 2020

First Submitted That Met QC Criteria

August 27, 2021

First Posted (Actual)

September 2, 2021

Study Record Updates

Last Update Posted (Actual)

November 28, 2022

Last Update Submitted That Met QC Criteria

November 25, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00087451

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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