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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
  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 (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.


Condition Intervention Phase
Ischemic Heart Disease
 Device: 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:

U.S. FDA Resources

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 ]

Estimated Enrollment: 80
Study Start Date: January 2011
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: January 2013 (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
 Device: physical activity monitors
physical activity monitors
Placebo Comparator: control
no stimulation of physical activity
 Device: physical activity monitors
physical activity monitors

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
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
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

No publications provided

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: October 1, 2012
Health Authority: Belgium: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on May 16, 2013