Telerehab II: secondary prevention of cardiovascular disease by means of telerehabilitation.
| ISRCTN | ISRCTN96672098 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN96672098 |
| Protocol serial number | N/A |
| Sponsor | Heart Centre Hasselt vzw (Belgium) |
| Funder | Heart Centre Hasselt vzw (Belgium) |
- Submission date
- 28/02/2013
- Registration date
- 17/04/2013
- Last edited
- 06/11/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
Cardiac rehabilitation (CR) is proven to be effective for coronary artery disease patients. However, uptake rates of the conventional CR remain poor. Patients often find it difficult for the conventional in-hospital CR to fit in their weekly time schedule. They sometimes cant attend because of traffic/travel issues. Telerehabilitation could overcome these problems, leading to better physical fitness and health among the cardiac patients. This study explored the effect of a telerehabilitation program on the patient's physical fitness.
Who can participate?
Coronary artery disease (CAD) patients, younger than 80 years old and that posses a personal computer with internet connection, could participate.
What does the study involve?
Participants were randomly allocated to one of two groups: a telerehabilitation group (intervention group) or a conventional cardiac rehabilitation group. In the intervention group, the study involved wearing a motion sensor that recorded the patients daily physical activity. Feedback was also given to the patients in the intervention group.
What are the possible benefits and risks of participating?
There were no risks associated with participating, except for sport injuries (these were only very rarely expected to occur because of the limited intensity of physical activity). The patients were able to benefit from the positive effects of daily exercise.
Where is the study run from?
The study was run from the Jessa Hospital, Hasselt in Belgium.
When is the study starting and how long is it expected to run for?
January 2011 to December 2012.
Who is funding the study?
The Heart Centre in Hasselt (Belgium)
Who is the main contact?
Prof. Dr. Dendale
paul.dendale@jessazh.be
Contact information
Scientific
Jessa Hospital
Stadsomvaart 11
Hasselt
3500
Belgium
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Prospective randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Telerehab II: a prospective randomised controlled trial that explores the effect on VO2 peak of coronary artery disease patients receiving telerehabilitation, with those receiving conventional cardiac rehabilitation |
| Study acronym | Telerehab II |
| Study objectives | The hypothesis is that a telerehabilitation program by means of a motion sensor with automated feedback can increase the patient's VO2 peak more, compared to conventional cardiac rehabilitation. |
| Ethics approval(s) | Medical Ethical Committee of Jessa Hospital, 10/12/2010 |
| Health condition(s) or problem(s) studied | Coronary artery disease |
| Intervention | 1. Conventional cardiac rehabilitation. 2. Telerehabilitation will consist of daily recording of the patient's physical activity. These data will be uploaded weekly on a personal computer and sent automatically to the caregivers.The patients will receive weekly new step goals, gradually increasing their daily activity level.The intervention will be carried out during 18 weeks. |
| Intervention type | Other |
| Primary outcome measure(s) |
1. Change in VO2 peak from baseline (week 1) to week 6 and week 18 of follow-up |
| Key secondary outcome measure(s) |
1. Change in HBA1c, lipid profile from baseline to week 18 |
| Completion date | 31/12/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 80 |
| Key inclusion criteria | 1. Patients (both male and female) that suffered an uncomplicated acute coronary syndrome (ACS) for which a percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) was performed 2. All included patients possessed a personal computer and internet connection 3. Their age did not exceed 80 years old |
| Key exclusion criteria | 1. Patients more than 80 years old 2. Patients that have an Implantable Cardioverter Defibrillator (ICD) or pacemaker 3. Patients that suffered from severe arrhythmias 4. Patients that had persistent exertional ischaemia after revascularization therapy. 5. Patients with severe heart failure (NYHA class III and IV) 6. Patients with neurological or orthopaedic disability, limiting their capability to walk and run |
| Date of first enrolment | 01/01/2011 |
| Date of final enrolment | 31/12/2012 |
Locations
Countries of recruitment
- Belgium
Study participating centre
3500
Belgium
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/02/2015 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
