Telerehab II: secondary prevention of cardiovascular disease by means of telerehabilitation.

ISRCTN	ISRCTN96672098
DOI	https://doi.org/10.1186/ISRCTN96672098
Secondary identifying numbers	N/A

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

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

Prof Paul Dendale
Scientific

Jessa Hospital
Stadsomvaart 11
Hasselt
3500
Belgium

Study information

Study design	Prospective randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Prevention
Participant information sheet	Not available in web format, please use the contact details below to request a patient 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	1. Change in VO2 peak from baseline (week 1) to week 6 and week 18 of follow-up 2. Change of daily step count from baseline to week 18 of follow-up
Secondary outcome measures	1. Change in HBA1c, lipid profile from baseline to week 18 2. Number and duration of hospitalisation after the start of the study 3. Mortality rate after the start of the study 4. Number of medication changes from baseline to week 18 of follow-up 5. Change in self-reported physical activity (IPAQ-questionnaire) from baseline to week 18 of follow-up
Overall study start date	01/01/2011
Completion date	31/12/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	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

Jessa Hospital

Hasselt
3500
Belgium

Sponsor information

Heart Centre Hasselt vzw (Belgium)
Hospital/treatment centre

Begeveldstraat
Bilzen
3740
Belgium

Website	http://www.jessazh.be/
"ROR"	https://ror.org/03tw90478

Funders

Funder type

Hospital/treatment centre

Heart Centre Hasselt vzw (Belgium)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	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