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Completed

NCT Number: NCT05033327

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nutrition and Exercise app

Behavioral

Personalized, home-based, interactive therapy app

Other names: Heal-Me

Primary outcomes

  1. 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.

Secondary outcomes

  1. 6-MWT

    Time frame: 12 weeks

    The change in distance walked in 6 minutes.

  2. Program Satisfaction

    Time frame: 12 weeks

    Self-reported satisfaction with the nutrition and exercise program.

Other outcomes

  1. 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.

  2. Thigh Muscle Measures

    Time frame: 12 weeks

    The change in thigh muscle thickness and echogenicity from baseline to end of study.

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Collaborators

  • Canadian National Transplant Research Program
  • Nutricia Foundation

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Sep 2, 2021
Registry last updated
Feb 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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