Ignite Creation Date:
2024-05-06 @ 2:26 AM
Last Modification Date:
2024-10-26 @ 11:18 AM
Study NCT ID:
NCT02047942
Status:
COMPLETED
Last Update Posted:
2019-06-24
First Post:
2014-01-27
Brief Title:
Telerehabilitation in Coronary Heart Disease
Sponsor:
KU Leuven
Organization:
KU Leuven
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2019-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TRiCH
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None