a Bike Application to Support Cardiac Patient (BackonBike)

February 20, 2019 updated by: prof. dr. Paul Dendale, Hasselt University

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

Completed

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

Observational

Enrollment (Actual)

75

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Hasselt, Belgium
        • Jessa Ziekenhuis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Low risk coronary artery disease patients that completed phase II of cardiac rehabilitation.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Impact on motivation
Time Frame: up to week 4
up to week 4

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to week 4
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
up to week 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hasselt University

Collaborators

Jessa Hospital

Investigators

  • Study Chair: Ines Frederix, drs., Universiteit Hasselt/ Jessa ziekenhuis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (Actual)

December 31, 2018

Study Completion (Actual)

December 31, 2018

Study Registration Dates

First Submitted

June 10, 2015

First Submitted That Met QC Criteria

June 10, 2015

First Posted (Estimate)

June 12, 2015

Study Record Updates

Last Update Posted (Actual)

February 21, 2019

Last Update Submitted That Met QC Criteria

February 20, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PDEN-IFRE 02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Coronary Artery Disease

Clinical Trials on Bike application arm

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in New Zealand

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe