- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
-
-
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Hasselt, Belgia
- Jessa Ziekenhuis
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
Bike application arm
The bike application arm contains cardiac patients that will be instructed to use the cycling application during a one month period.
|
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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Impact on motivation
Tidsramme: up to week 4
|
up to week 4
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Usability of the cycling application
Tidsramme: Up to week 4
|
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.
|
Up to week 4
|
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Impact on fear
Tidsramme: up to week 4
|
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
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Studiestol: Ines Frederix, drs., Universiteit Hasselt/ Jessa ziekenhuis
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- PDEN-IFRE 02
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