- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Hasselt, Belgium
- Jessa Ziekenhuis
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Impact on motivation
Time Frame: up to week 4
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up to week 4
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Usability of the cycling application
Time Frame: 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
Time Frame: 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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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Ines Frederix, drs., Universiteit Hasselt/ Jessa ziekenhuis
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PDEN-IFRE 02
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