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Telemonitoring During Phase 2-3 Cardiac Rehabilitation (TeleRehabII)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Paul Dendale, Jessa Hospital
ClinicalTrials.gov Identifier:
NCT01252030
First received: December 1, 2010
Last updated: August 15, 2016
Last verified: August 2016
  Purpose

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 Intervention Phase
Ischemic Heart Disease
Device: physical activity monitors
Other: No physical activity monitors
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Impact of Telemonitoring Intervention on Physical Activity, CVD Risk Factors, During Phase 2-3 Cardiac Rehabilitation

Resource links provided by NLM:


Further study details as provided by Jessa Hospital:

Primary Outcome Measures:
  • Physical activity [ Time Frame: every week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • exercise capacity [ Time Frame: every 6 weeks ] [ Designated as safety issue: No ]
  • blood lipid profile, glucose and insulin level [ Time Frame: every 6 weeks ] [ Designated as safety issue: No ]
  • mortality and morbidity [ Time Frame: continuously ] [ Designated as safety issue: Yes ]

Enrollment: 80
Study Start Date: January 2011
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: intervention
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: CAD patients following phase 2-3 rehabilitation -

Exclusion Criteria: CHF, pacemaker, ICD, any disability limiting exercise participation

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01252030

Locations
Belgium
Jessa Hospital
Hasselt, Belgium, 3500
Sponsors and Collaborators
Jessa Hospital
Investigators
Principal Investigator: Paul A Dendale, MD, PhD University of Hasselt, Hasselt, Belgium
  More Information

Responsible Party: Paul Dendale, dr, Jessa Hospital
ClinicalTrials.gov Identifier: NCT01252030     History of Changes
Other Study ID Numbers: Telemonitoring 2 
Study First Received: December 1, 2010
Last Updated: August 15, 2016
Health Authority: Belgium: Institutional Review Board

Keywords provided by Jessa Hospital:
CAD, physical activity, rehabilitation, prevention

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

ClinicalTrials.gov processed this record on September 30, 2016