Telerehabilitation in Coronary Heart Disease

Not Applicable

Completed

• Conditions: Myocardial Infarction; Percutaneous Transluminal Cutting Balloon Angioplasty of Popliteal Vein Using Fluoroscopic Guidance; Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD))
• Interventions: Behavioral: Home-based training with telemonitoring guidance; Behavioral: Center-based cardiac rehabilitation

• Registration Number: NCT02047942
• Lead Sponsor: KU Leuven

Brief Summary

Cardiovascular diseases are the main cause of death worldwide. Aerobic fitness is related to long-term survival and a reduction in mortality and recurrent nonfatal myocardial infarction in subjects with cardiovascular disease. However, the majority of cardiac patients do not engage in enough physical activity to obtain benefits or in the long-term struggle to maintain a physically active lifestyle. There is a need for innovative rehabilitation methods aiming at increasing longer-term adherence and hence more sustained effects on health related physical fitness. One strategy might be the use of home-based training in combination of telemonitoring guidance. Therefore, the main objective of this randomized controlled clinical trial is to compare the longer-term (=1 year) effects of a 3-month supervised center-based rehabilitation program with a patient-tailored home-based cardiac rehabilitation program with telemonitoring guidance in CAD patients (phase III). The primary outcome measure is physical fitness. It is hypothesized that patients randomized to a home-based training program with telemonitoring guidance will demonstrate higher levels of physical activity at one year of follow-up, resulting in higher levels of physical fitness, compared to patients who have been enrolled to the supervised center-based cardiac rehabilitation program or control group. Ninety patients will be randomized to Home-based training, a center-based cardiac rehabilitation program or an advice only group (= control group). Assessment will be performed at baseline, immediately at completion of the intervention and at one-year of follow-up and will include measurements of exercise tolerance, cardiovascular risk factors, physical activity, muscle strength, endothelial function, health-related quality.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-01-27
• Study First Submitted QC: 2014-01-27
• Study First Posted: 2014-01-28
• Study Start: 2014-02
• Primary Completion: 2017-08
• Study Completion: 2017-08
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-20
• Last Update Posted: 2019-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Patients with CAD (post-PCI, post-MI, post-CABG)
• Patients on optimal medical treatment and stable with regard to symptoms and pharmacotherapy for at least 6 weeks
• Patients have successfully completed the 3 month ambulatory cardiac rehabilitation in hospital program
• 39 yrs < age < 76 years
• access to internet facilities or PC at home

Exclusion Criteria

• Significant undercurrent illness last 6 weeks
• Known severe ventricular arrhythmia with functional or prognostic significance; significant myocardial ischemia, hemodynamic deterioration or exercise-induced arrhythmia at screening or heart disease that limits exercise
• Co-morbidity that may significantly influence one-year prognosis
• Functional of mental disability that may limit exercise

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Home-based training with telemonitoring guidance	Home-based training with telemonitoring guidance	Patients will receive an patient-tailored exercise prescription and will be asked to perform the exercise sessions in their home environment wearing heart rate monitors. Training data will be accessed by the research group on weekly basis in order to keep a record of frequency; duration and intensity of the sessions. Feedback will be given weekly to every patient.
Center-based cardiac rehabilitation	Center-based cardiac rehabilitation	Patients randomized to the center-based training group will continue their training sessions at the outpatient clinics of UZ Leuven under direct supervision of physical therapists

Primary Outcome Measures

Name	Time	Method
exercise tolerance	12 weeks	comparison of evolution of exercise tolerance from baseline to 12 weeks

Trial Locations

Locations (1)

KU Leuven; 🇧🇪 Leuven, Belgium