Telemonitoring During Phase 2-3 Cardiac Rehabilitation (TeleRehabII)
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|ClinicalTrials.gov Identifier: NCT01252030|
Recruitment Status : Completed
First Posted : December 2, 2010
Last Update Posted : August 17, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Ischemic Heart Disease||Device: physical activity monitors Other: No physical activity monitors||Phase 2|
We included patients that suffered from an acute coronary syndrome for which a percutaneous coronary intervention or coronary artery bypass graft was performed.
All patients had access to a computer with internet connection.
Patients that (i) were more than 80 years old, (ii) had an implantable cardioverter defibrillator or pacemaker, (iii) suffered from severe arrhythmias, or (iv) had persistent exertional ischaemia after revascularization therapy, were not invited to participate in this study. Patients with severe heart failure (NYHA class III and IV), or neurological or orthopaedic disability limiting their capability to exercise, were also excluded.
The study was a prospective randomized controlled trial, including an 18-week intervention. All patients were included after week six of their conventional phase II cardiac rehabilitation (CR). During phase II of conventional CR, all patients (those in the intervention and control group) were educated about the core components of CR including healthy nutrition, risk factor management (lipids, hypertension, weight, diabetes, and smoking), psychosocial management and physical activity counseling.
During the first six weeks of the intervention, patients in the intervention group continued exercising in the hospital's rehabilitation centre using an outpatient service, in combination with an exercise training program with telemonitoring support. Patients in the control group continued exercising in the hospital's rehabilitation centre using an out-patient service, without participating in the exercise training program with telemonitoring support. Starting from the seventh week in the study period, patients in the intervention group finished their phase II CR in the hospital's rehabilitation centre but continued their exercise training program with telemonitoring support; patients in the control group finished their phase II CR in the hospital's rehabilitation centre.
All patients underwent a maximal cardiopulmonary exercise test (CPET) and a clinical examination (with determination of waist circumference, blood pressure, body mass index) after randomization, and also during the sixth and 18th week of the Telerehab II study period. A fasting blood sampling was taken from all patients during the first and 18th week of the Telerehab II study period.
The hypothesis was that telemonitoring of physical activity will increase physical activity, and improve cardiovascular disease risk factors, in CAD patients attending phase 2-3 cardiac rehabilitation.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Impact of Telemonitoring Intervention on Physical Activity, CVD Risk Factors, During Phase 2-3 Cardiac Rehabilitation|
|Study Start Date :||January 2011|
|Actual Primary Completion Date :||December 2012|
|Actual Study Completion Date :||December 2012|
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
physical activity monitors
Placebo Comparator: control
no stimulation of physical activity
Other: No physical activity monitors
No physical activity monitors
- Physical activity [ Time Frame: every week ]
- exercise capacity [ Time Frame: every 6 weeks ]
- blood lipid profile, glucose and insulin level [ Time Frame: every 6 weeks ]
- mortality and morbidity [ Time Frame: continuously ]
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): NCT01252030
|Hasselt, Belgium, 3500|
|Principal Investigator:||Paul A Dendale, MD, PhD||University of Hasselt, Hasselt, Belgium|