- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT02470143
a Bike Application to Support Cardiac Patient (BackonBike)
Pilot Study, How a Bike Application Can Support Cardiac Patients in Their Rehabilitation Program?
The pilot study will investigate the usability of a mobile cycling application in a cardiac patient population during a one month study period.
The application's effectiveness regarding ability to reduce fear and increase motivation to exercise will be assessed.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
This pilot study investigates the use of a mobile cycling application for patients with a cardiac disease that was developed by the Expertise Centre for Digital Media of Hasselt University in collaboration with the Faculty of Medicine & Life Sciences of Hasselt University. During the pilot study, the use of the cycling application and its impact on fear and motivation of patients with a cardiac disease during the rehabilitation is studied. The cycling application will be used on a smartphone, in combination with a wrist-worn heart rate monitor.
During the study, the patients will use the cycling application for one month, in which they can make use of the cycling application each time they are cycling outdoor in their home environment. Through questionnaires and interviews, the patients' experiences with respect to fear and motivation will be collected. Furthermore, the usability of the cycling application is evaluated through these questionnaires and interviews.
Studietype
Inschrijving (Werkelijk)
Contacten en locaties
Studie Locaties
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Hasselt, België
- Jessa Ziekenhuis
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
Inclusion Criteria:
- Patients with coronary artery disease for which they received a percutaneous coronary intervention, coronary artery bypass grafting or drugs only.
- Patients that have completed the standard cardiac rehabilitation program
- Patients who have access to a computer and a WiFi internet connection
- Patients that are able to go to the rehabilitation centre ReGo of Jessa Hospital
- Patients who signed the informed consent document
Exclusion Criteria:
- Patients with a history of VF, sustained VT and/or supraventricular tachycardia during the last 6 months before enrollment.
- Patients who due to cognitive, neurological and/or musculoskeletal constraints are unable to ride a bicycle.
- Patients with a pacemaker.
- Non-Dutch speaking patients
- Patients who simultaneously participate in another study
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
|---|---|
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Bike application arm
The bike application arm contains cardiac patients that will be instructed to use the cycling application during a one month period.
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The intervention patients will use the cycling application on a smartphone, in combination with a wrist-worn heart rate monitor.
During the study, the patients will use the cycling application for one month, in which they can make use of the cycling application each time they are cycling outdoor in their home environment.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
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Impact on motivation
Tijdsspanne: up to week 4
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up to week 4
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Usability of the cycling application
Tijdsspanne: Up to week 4
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By means of a questionnaire and an interview, the participants are asked about the usability of the application.
This information will give insights in parts of the application that could be improved considering the usability.
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Up to week 4
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Impact on fear
Tijdsspanne: up to week 4
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By means of a questionnaire and an interview, questions are asked about participants' motivation for a tour
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up to week 4
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Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Studie stoel: Ines Frederix, drs., Universiteit Hasselt/ Jessa ziekenhuis
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- PDEN-IFRE 02
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