NCT01252030

Brief Summary

In this study, 80 coronary artery disease patients with successful coronary revascularisation (by CABG or PCI) will be included. Patients are excluded in case of: congestive heart failure, ICD or pacemaker, any disability limiting exercise participation. These patients are attending phase 2-3 cardiac rehabilitation, and have completed 6 weeks of rehabilitation. Next, subjects are randomly assigned to a control group or an intervention group. Outcome parameters: physical activity, exercise capacity, blood glucose, insulin level and lipid profile, body weight and waist circumference, cardiovascular morbidity and mortality. Hypothesis: telemonitoring of physical activity will increase physical activity, and improve cardiovascular disease risk factors, in CAD patients attending phase 2-3 cardiac rehabilitation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2011

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

December 1, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 2, 2010

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2011

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

August 17, 2016

Status Verified

August 1, 2016

Enrollment Period

1.9 years

First QC Date

December 1, 2010

Last Update Submit

August 15, 2016

Conditions

Ischemic Heart Disease

Keywords

CAD, physical activity, rehabilitation, prevention

Outcome Measures

Primary Outcomes (1)

  • Physical activity

    every week

Secondary Outcomes (3)

  • exercise capacity

    every 6 weeks

  • blood lipid profile, glucose and insulin level

    every 6 weeks

  • mortality and morbidity

    continuously

Study Arms (2)

intervention

EXPERIMENTAL

stimulation of physical activity by messages sent through e mail or SMS; in combination with monitoring of physical activity with physical activity monitors

Device: physical activity monitors

control

PLACEBO COMPARATOR

no stimulation of physical activity

Other: No physical activity monitors

Interventions

physical activity monitorsDEVICE

physical activity monitors

intervention
No physical activity monitorsOTHER

No physical activity monitors

control

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jessa Hospital

Hasselt, 3500, Belgium

Location

MeSH Terms

Conditions

Myocardial IschemiaMotor Activity

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular DiseasesBehavior

Study Officials

  • Paul A Dendale, MD, PhD

    University of Hasselt, Hasselt, Belgium

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
dr

Study Record Dates

First Submitted

December 1, 2010

First Posted

December 2, 2010

Study Start

January 1, 2011

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

August 17, 2016

Record last verified: 2016-08

Locations

BE(1)