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Telemonitoring During Phase 2-3 Cardiac Rehabilitation (TeleRehabII)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Paul Dendale, Jessa Hospital
ClinicalTrials.gov Identifier:
NCT01252030
First received: December 1, 2010
Last updated: October 1, 2012
Last verified: September 2012
History of Changes

December 1, 2010
October 1, 2012
January 2011
January 2013   (final data collection date for primary outcome measure)
Physical activity [ Time Frame: every week ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01252030 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Telemonitoring During Phase 2-3 Cardiac Rehabilitation
Impact of Telemonitoring Intervention on Physical Activity, CVD Risk Factors, During Phase 2-3 Cardiac Rehabilitation

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 (continue rehabilitation for another 18 weeks) or an intervention group (continue rehabilitation for another 18 weeks, but being confronted regularly with their physical activity (by wearing physical activity monitors)).

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 not increase physical activity, nor improve cardiovascular disease risk factors, in CAD patients attending phase 2-3 cardiac rehabilitation.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Ischemic Heart Disease
Device: physical activity monitors
physical activity monitors
  • Experimental: intervention
    stimulation of physical activity by messages sent through e mail or SMS
    Intervention: Device: physical activity monitors
  • Placebo Comparator: control
    no stimulation of physical activity
    Intervention: Device: physical activity monitors
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
80
March 2013
January 2013   (final data collection date for primary outcome measure)

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

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

-
Both
40 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT01252030
Telemonitoring 2
Yes
Paul Dendale, Jessa Hospital
Jessa Hospital
Not Provided
Principal Investigator: Paul A Dendale, MD, PhD University of Hasselt, Hasselt, Belgium
Jessa Hospital
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP