Ischemic Heart DiseasePhase 2TeleRehabIINCT01252030
Telemonitoring During Phase 2-3 Cardiac Rehabilitation
A Phase 2 study testing physical activity monitors and No physical activity monitors in people with Ischemic Heart Disease, run by Jessa Hospital at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Ischemic Heart Disease
- What is being tested?
- physical activity monitors and No physical activity monitors
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 2011to Dec 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion Criteria: CAD patients following phase 2-3 rehabilitation -
Exclusion Criteria: CHF, pacemaker, ICD, any disability limiting exercise participation
-
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Telemonitoring Intervention on Physical Activity, CVD Risk Factors, During Phase 2-3 Cardiac Rehabilitation
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.
Read more
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.
Read the 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.
- Conditions
- Ischemic Heart Disease
- Being tested
- physical activity monitors, No physical activity monitors
- Keywords
- CAD, physical activity, rehabilitation, prevention
- Medical subject headings
- Myocardial Ischemia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physical activity monitorsDevice
physical activity monitors
No physical activity monitorsOther
No physical activity monitors
| Study group | Role | What they receive |
|---|---|---|
| intervention | Experimental | stimulation of physical activity by messages sent through e mail or SMS; in combination with monitoring of physical activity with physical activity monitors Receives: Device: physical activity monitors |
| control | Placebo comparator | no stimulation of physical activity Receives: Other: No physical activity monitors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical activity
Measured: every week
Secondary outcomes (3)
exercise capacity
Measured: every 6 weeks
blood lipid profile, glucose and insulin level
Measured: every 6 weeks
mortality and morbidity
Measured: continuously
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2010 (estimated)
- Study startJan 2011
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jessa Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paul Dendale, Jessa Hospital
- Investigators
- Paul A Dendale, MD, PhD, Principal investigator, University of Hasselt, Hasselt, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01252030
- Sponsor's protocol ID
- Telemonitoring 2
- Acronym
- TeleRehabII
- Status last verified
- Aug 2016
- First submitted
- 1 Dec 2010
- Last updated
- 17 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Telemonitoring Intervention on Physical Activity, CVD Risk Factors, During Phase 2-3 Cardiac Rehabilitation
- ClinicalTrials.gov ID
- NCT01252030
- Acronym / sponsor ID
- TeleRehabII / Telemonitoring 2
- Conditions
- Ischemic Heart Disease
- Keywords
- CAD, physical activity, rehabilitation, prevention
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Jessa HospitalUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 2 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention | Experimental | Device: physical activity monitorsstimulation of physical activity by messages sent through e mail or SMS; in combination with monitoring of physical activity with physical activity monitors |
| control | Placebo comparator | Other: No physical activity monitorsno stimulation of physical activity |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| physical activity monitorsphysical activity monitors | Device | intervention |
| No physical activity monitorsNo physical activity monitors | Other | control |
Primary outcome
Physical activity
Time frame: every week
3 secondary outcomes
exercise capacity
Time frame: every 6 weeks
blood lipid profile, glucose and insulin level
Time frame: every 6 weeks
mortality and morbidity
Time frame: continuously
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul A Dendale, MD, PhD principal investigator
University of Hasselt, Hasselt, Belgium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing physical activity monitors and No physical activity monitors in people with Ischemic Heart Disease, run by Jessa Hospital at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical activity (time frame: every week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2016.