Ignite Creation Date:
2024-05-05 @ 11:07 PM
Last Modification Date:
2024-10-26 @ 10:28 AM
Study NCT ID:
NCT01252030
Status:
COMPLETED
Last Update Posted:
2016-08-17
First Post:
2010-12-01
Brief Title:
Telemonitoring During Phase 2-3 Cardiac Rehabilitation
Sponsor:
Jessa Hospital
Organization:
Jessa Hospital
Study Overview
Official Title:
Impact of Telemonitoring Intervention on Physical Activity CVD Risk Factors During Phase 2-3 Cardiac Rehabilitation
Status:
COMPLETED
Status Verified Date:
2016-08
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:
TeleRehabII
Brief Summary:
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
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
Detailed Description:
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 hospitals 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 hospitals 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 hospitals rehabilitation centre but continued their exercise training program with telemonitoring support patients in the control group finished their phase II CR in the hospitals 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
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 hospitals 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 hospitals 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 hospitals rehabilitation centre but continued their exercise training program with telemonitoring support patients in the control group finished their phase II CR in the hospitals 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
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