Condition category
Circulatory System
Date applied
28/02/2013
Date assigned
17/04/2013
Last edited
06/11/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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 can’t 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 patient’s 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

Trial website

Contact information

Type

Scientific

Primary contact

Prof Paul Dendale

ORCID ID

Contact details

Jessa Hospital
Stadsomvaart 11
Hasselt
3500
Belgium

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

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

Acronym

Telerehab II

Study hypothesis

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

Medical Ethical Committee of Jessa Hospital, 10/12/2010

Study design

Prospective randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/01/2011

Overall trial end date

31/12/2012

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

80

Participant 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

Recruitment start date

01/01/2011

Recruitment end date

31/12/2012

Locations

Countries of recruitment

Belgium

Trial participating centre

Jessa Hospital
Hasselt
3500
Belgium

Sponsor information

Organisation

Heart Centre Hasselt vzw (Belgium)

Sponsor details

Begeveldstraat
Bilzen
3740
Belgium

Sponsor type

Hospital/treatment centre

Website

http://www.jessazh.be/

Funders

Funder type

Hospital/treatment centre

Funder name

Heart Centre Hasselt vzw (Belgium)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2012 meeting abstract results in http://poj.peeters-leuven.be/content.php?url=article&id=2146575&journal_code=AC
2. 2013 meeting abstract results in http://poj.peeters-leuven.be/content.php?url=article&id=2959636&journal_code=AC
3. 2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/24249840

Publication citations

Additional files

Editorial Notes