a Bike Application to Support Cardiac Patient

Coronary Artery Disease Clinical Trial

— BackonBike  

Official title:

Pilot Study, How a Bike Application Can Support Cardiac Patients in Their Rehabilitation Program?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02470143
• Other study ID #: PDEN-IFRE 02
• Status: Completed
• Start date: August 2015
• Est. completion date: December 31, 2018

Study information

• Verified date: February 2019
• Source: Hasselt University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Behavioral:
• Bike application arm
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.

Locations

Country	Name	City	State
Belgium	Jessa Ziekenhuis	Hasselt

Sponsors (2)

Lead Sponsor	Collaborator
Hasselt University	Jessa Hospital

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Impact on motivation		up to week 4
Secondary	Usability of the cycling application	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
Secondary	Impact on fear	By means of a questionnaire and an interview, questions are asked about participants' motivation for a tour	up to week 4