University of Alberta
Edmonton, Alberta, T6G 2X8, Canada
NCT Number: NCT05033327
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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Notify Me18 year and older
All sexes
Interventional
Not applicable
Edmonton, Alberta, T6G 2X8, Canada
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Personalized, home-based, interactive therapy app
Other names: Heal-Me
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.
Time frame: 12 weeks
The change in distance walked in 6 minutes.
Time frame: 12 weeks
Self-reported satisfaction with the nutrition and exercise program.
Time frame: 12 weeks
The change in time required to complete 5x sit-to-stands from baseline to end of study.
Time frame: 12 weeks
The change in thigh muscle thickness and echogenicity from baseline to end of study.
University of Alberta
Other
The Acceptability of an App-based, Interactive, Personalized Nutrition and Exercise Program to Support Self-management in Cirrhosis: a Pilot Study
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