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Completed

NCT Number: NCT01252030

Telemonitoring 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 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.

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Key information

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Jessa Hospital

Hasselt, 3500, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

CAD patients following phase 2-3 rehabilitation -

Exclusion criteria

CHF, pacemaker, ICD, any disability limiting exercise participation

-

Treatment and study plan

physical activity monitors

Device

physical activity monitors

No physical activity monitors

Other

No physical activity monitors

Primary outcomes

  1. Physical activity

    Time frame: every week

Secondary outcomes

  1. exercise capacity

    Time frame: every 6 weeks

  2. blood lipid profile, glucose and insulin level

    Time frame: every 6 weeks

  3. mortality and morbidity

    Time frame: continuously

Sponsors and collaborators

Lead sponsor

Jessa Hospital

Other

Registry information

Official study title

Impact of Telemonitoring Intervention on Physical Activity, CVD Risk Factors, During Phase 2-3 Cardiac Rehabilitation

Acronym: TeleRehabII

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Dec 2, 2010
Registry last updated
Aug 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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