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Effectiveness of the Aktivplan Digital Intervention for Supporting Regular Heart-healthy Levels of Physical Activity Following Completion of a Phase II Rehabilitation Programme: a Clinical Pilot Study
The goal of this clinical pilot / feasibility study is to determine the feasibility of conducting a large-scale clinical effectiveness trial of the aktivplan digital intervention in cardiac rehabilitation patients. The main questions this study aims to answer are: * Is it feasible to conduct a large-scale (fully powered) effectiveness trial of the aktivplan digital intervention? * What is the usability, user experience and user acceptance of the aktivplan digital intervention? Patients enrolled in a phase II cardiac rehabilitation programme will be randomly allocated to either the intervention group (aktivplan digital intervention) ot the usual care control group and followed-up for 10 weeks after discharge from cardiac rehabilitation. Patients in the intervention group will be given the aktivplan application (app) on their smartphone. A rehabilitation professional will plan a personalised heart-healthy physical activity plan together with the patient and enter it to the aktivplan app. The patient will be asked to follow their personal physical activity plan for 10 weeks, using the aktivplan app to document completed physical activity sessions. Patients in the control group will receive the usual standard of care without the aktivplan digital intervention. Researchers will analyse information such as the rate of recruitment, participant attrition, data completeness and technical stability of the app to determine the feasibility of conducting a large-scale clinical effectiveness trial.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
REHA Zentrum Salzburg
Salzburg, Salzburg, Austria
Reha-Klinik Montafon
Schruns, Vorarlberg, Austria
Start Date
October 2, 2023
Primary Completion Date
July 29, 2024
Completion Date
August 31, 2024
Last Updated
October 9, 2024
34
ACTUAL participants
aktivplan
OTHER
Usual care
OTHER
Lead Sponsor
Ludwig Boltzmann Institute for Digital Health and Prevention
Collaborators
NCT06909773
NCT06505109
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT06189313