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Telemonitoring During Phase 2-3 Cardiac Rehabilitation (TeleRehabII)

Primary Purpose

Ischemic Heart Disease

Status
Completed
Phase
Phase 2
Locations
Belgium
Study Type
Interventional
Intervention
physical activity monitors
No physical activity monitors
Sponsored by
Jessa Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Ischemic Heart Disease focused on measuring CAD, physical activity, rehabilitation, prevention

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: CAD patients following phase 2-3 rehabilitation -

Exclusion Criteria: CHF, pacemaker, ICD, any disability limiting exercise participation

-

Sites / Locations

  • Jessa Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

intervention

control

Arm Description

stimulation of physical activity by messages sent through e mail or SMS; in combination with monitoring of physical activity with physical activity monitors

no stimulation of physical activity

Outcomes

Primary Outcome Measures

Physical activity

Secondary Outcome Measures

exercise capacity
blood lipid profile, glucose and insulin level
mortality and morbidity

Full Information

First Posted
December 1, 2010
Last Updated
August 15, 2016
Sponsor
Jessa Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01252030
Brief Title
Telemonitoring During Phase 2-3 Cardiac Rehabilitation
Acronym
TeleRehabII
Official Title
Impact of Telemonitoring Intervention on Physical Activity, CVD Risk Factors, During Phase 2-3 Cardiac Rehabilitation
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jessa Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Heart Disease
Keywords
CAD, physical activity, rehabilitation, prevention

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
intervention
Arm Type
Experimental
Arm Description
stimulation of physical activity by messages sent through e mail or SMS; in combination with monitoring of physical activity with physical activity monitors
Arm Title
control
Arm Type
Placebo Comparator
Arm Description
no stimulation of physical activity
Intervention Type
Device
Intervention Name(s)
physical activity monitors
Intervention Description
physical activity monitors
Intervention Type
Other
Intervention Name(s)
No physical activity monitors
Intervention Description
No physical activity monitors
Primary Outcome Measure Information:
Title
Physical activity
Time Frame
every week
Secondary Outcome Measure Information:
Title
exercise capacity
Time Frame
every 6 weeks
Title
blood lipid profile, glucose and insulin level
Time Frame
every 6 weeks
Title
mortality and morbidity
Time Frame
continuously

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: CAD patients following phase 2-3 rehabilitation - Exclusion Criteria: CHF, pacemaker, ICD, any disability limiting exercise participation -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul A Dendale, MD, PhD
Organizational Affiliation
University of Hasselt, Hasselt, Belgium
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jessa Hospital
City
Hasselt
ZIP/Postal Code
3500
Country
Belgium

12. IPD Sharing Statement

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Telemonitoring During Phase 2-3 Cardiac Rehabilitation

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