NCT02470143

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 10, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 12, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2015

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

February 21, 2019

Status Verified

February 1, 2019

Enrollment Period

3.4 years

First QC Date

June 10, 2015

Last Update Submit

February 20, 2019

Conditions

Keywords

Human-computer interactionFearMotivationUsability

Outcome Measures

Primary Outcomes (1)

  • Impact on motivation

    up to week 4

Secondary Outcomes (2)

  • Usability of the cycling application

    Up to week 4

  • Impact on fear

    up to week 4

Study Arms (1)

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

Interventions

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.

Bike application arm

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jessa Ziekenhuis

Hasselt, Belgium

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Ines Frederix, drs.

    Universiteit Hasselt/ Jessa ziekenhuis

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
prof. dr.

Study Record Dates

First Submitted

June 10, 2015

First Posted

June 12, 2015

Study Start

August 1, 2015

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

February 21, 2019

Record last verified: 2019-02

Locations