- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
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Hasselt, Belgio
- Jessa Ziekenhuis
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
|---|---|
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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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
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Impact on motivation
Lasso di tempo: up to week 4
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up to week 4
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Usability of the cycling application
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Cattedra di studio: Ines Frederix, drs., Universiteit Hasselt/ Jessa ziekenhuis
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- PDEN-IFRE 02
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .