Telerehabilitation in Coronary Heart Disease

Myocardial Infarction Clinical Trial

— TRiCH  

Official title:

A Randomized Controlled Trial Comparing Home-based Training With Telemonitoring Guidance Versus Center-based Cardiac Rehabilitation in Patients With Coronary Heart Disease: the TRiCH-study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02047942
• Other study ID #: MOVE-AGE_09_2013
• Status: Completed
• Phase: N/A
• Start date: February 2014
• Est. completion date: August 2017

Study information

• Verified date: June 2019
• Source: KU Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD))
• Coronary Disease
• Heart Diseases
• Infarction
• Myocardial Infarction
• Myocardial Ischemia
• Percutaneous Transluminal Cutting Balloon Angioplasty of Popliteal Vein Using Fluoroscopic Guidance

Intervention

Behavioral:
• Center-based cardiac rehabilitation

• Home-based training with telemonitoring guidance

Locations

Country	Name	City	State
Belgium	KU Leuven	Leuven

Sponsors (3)

Lead Sponsor	Collaborator
KU Leuven	Hasselt University, Jessa Hospital

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	exercise tolerance	comparison of evolution of exercise tolerance from baseline to one-year	1 year
Primary	exercise tolerance	comparison of evolution of exercise tolerance from baseline to 12 weeks	12 weeks