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Clinical 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.

Clinical Trial 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

Related Conditions & MeSH terms

NCT number NCT05033327
Study type Interventional
Source University of Alberta
Contact Puneeta Tandon, MD MSc
Phone 780-492-9844
Email [email protected]
Status Recruiting
Phase N/A
Start date April 20, 2021
Completion date December 2025

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