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a Bike Application to Support Cardiac Patient (BackonBike)

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ClinicalTrials.gov Identifier: NCT02470143
Recruitment Status : Completed
First Posted : June 12, 2015
Last Update Posted : February 21, 2019
Sponsor:
Collaborator:
Jessa Hospital
Information provided by (Responsible Party):
prof. dr. Paul Dendale, Hasselt University

Brief 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.


Condition or disease Intervention/treatment
Coronary Artery Disease Behavioral: Bike application arm

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.


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Study Type : Observational
Actual Enrollment : 75 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Pilot Study, How a Bike Application Can Support Cardiac Patients in Their Rehabilitation Program?
Study Start Date : August 2015
Actual Primary Completion Date : December 31, 2018
Actual Study Completion Date : December 31, 2018

Group/Cohort Intervention/treatment
Bike application arm
The bike application arm contains cardiac patients that will be instructed to use the cycling application during a one month period.
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.




Primary Outcome Measures :
  1. Impact on motivation [ Time Frame: up to week 4 ]

Secondary Outcome Measures :
  1. Usability of the cycling application [ Time Frame: 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.

  2. Impact on fear [ Time Frame: 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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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Low risk coronary artery disease patients that completed phase II of cardiac rehabilitation.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02470143


Locations
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Belgium
Jessa Ziekenhuis
Hasselt, Belgium
Sponsors and Collaborators
Hasselt University
Jessa Hospital
Investigators
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Study Chair: Ines Frederix, drs. Universiteit Hasselt/ Jessa ziekenhuis

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Responsible Party: prof. dr. Paul Dendale, prof. dr., Hasselt University
ClinicalTrials.gov Identifier: NCT02470143     History of Changes
Other Study ID Numbers: PDEN-IFRE 02
First Posted: June 12, 2015    Key Record Dates
Last Update Posted: February 21, 2019
Last Verified: February 2019

Keywords provided by prof. dr. Paul Dendale, Hasselt University:
Human-computer interaction
Fear
Motivation
Usability

Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases