Effectiveness of a comprehensive telerehabilitation program for the heart

ISRCTN	ISRCTN29243064
DOI	https://doi.org/10.1186/ISRCTN29243064
Secondary identifying numbers	N/A

Submission date: 10/01/2015
Registration date: 21/01/2015
Last edited: 09/02/2023

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
Rehabilitation using the internet (telerehabilitation) has been proposed as an addition or alternative to standard cardiac rehabilitation (CR) to address the low use of standard CR programmes. The aim of this study is to test whether the addition of an internet cardiac telerehabilitation program to standard care improves long-term physical fitness in patients with heart disease.

Who can participate?
Men and women aged between 18 and 80 with heart disease (heart failure and diseases of the blood vessels supplying the heart muscle)

What does the study involve?
Half the patients receive standard CR and half receive standard CR and an internet telerehabilitation program (composed of physical activity monitoring and dietary, smoking cessation and activity coaching).

What are the possible benefits and risks of participating?
The possible benefits are an increase in physical fitness, improvements in risk factors that cause heart disease and reduction in the number of rehospitalisations. There are almost no risks.

Where is the study run from?
Three hospitals in Belgium: Jessa Hospital, Ziekenhuis Oost-Limburg and St Fransiscus Hospital

When is the study starting and how long is it expected to run for?
February 2013 to February 2015

Who is funding the study?
Flanders Care (Belgium) and Fonds Wetenschappelijk Onderzoek (Belgium)

Who is the main contact?
Prof. Paul Dendale

Contact information

Dr Ines Frederix
Scientific

Beatrijslaan 105
3110 Rotselaar
Rotselaar
3110
Belgium

Study information

Study design	Multicentre randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	Long-term effectiveness of a comprehensive cardiac telerehabilitation program (Telerehab III): a randomised controlled trial
Study acronym	Telerehab III
Study objectives	Addition of an internet-based cardiac telerehabilitation program to usual care improves long-term physical fitness in cardiac patients.
Ethics approval(s)	Ethics board of Ziekenhuis Oost-Limburg/Hasselt University/Jessa, 14/12/2012, ref: 12/085L
Health condition(s) or problem(s) studied	Coronary artery disease and heart failure
Intervention	1. Patients in the intervention group were provided with an internet-based telerehabilitation program in addition to conventional centre-based cardiac rehabilitation. The telerehabilitation program was composed of physical activity telemonitoring (Yorbody accelerometer) and dietary, smoking cessation and activity telecoaching. 2. Study nurse led training was given to patients within 7 days after randomisation. They were provided with some background and general information about the study design, content and main hypotheses of Telerehab III. Patients were taught how to install the telerehabilitation program on their computer and use the motion sensor. This presentation was followed by a 1 hour practical training session in which patients were familiarised with the accelerometer and associated webpage. They were instructed on how to install the program at home; if they had questions and/or technical difficulties, they were provided with technical support. 3. Patients receiving the intervention were prescribed literature on patient-specific exercise training protocols, based on maximal cardiopulmonary exercise test and calculated body-mass index (BMI) at the start of the study. Patients with a high aerobic capacity (defined as peak oxygen consumption [VO2] of at least 80% predicted) were prescribed with exercise training at an intensity of at least 100 steps per minute, for at least three times per week and a minimum session of 30 minutes. The instructed volume of steps was set at 10000–12000 per day for patients with a BMI greater than 30 kg/m2 and 8000–10000 per day for patients with a BMI of less 30 kg/m2. Patients with a low aerobic capacity (defined as VO2 peak of less than 80% predicted) were allowed to choose the intensity of exercise sessions. The instructed volume of steps was again set at 10000–12000 steps per day for patients with a BMI of greater than 30 kg/m2 and 8000–10000 steps per day for patients with a BMI of less than 30 kg/m2. 4. Patients were instructed to wear the motion sensor during the whole study, except while bathing or sleeping. They uploaded data at least every 2 weeks to a secure webpage with an USB-connection because of the accelerometer’s storage capacity of 14 days. The webpage displayed uploaded physical activities, enabling patients to self-monitor these data. Based on the uploaded data, a semi-automatic telecoaching system provided patients with weekly feedback through e-mail or short message service (SMS) or both. The feedback was intended to encourage patients to achieve the goals as predefined in the patient-specific exercise training protocols. 5. Intervention patients were provided with weekly dietary advice, sent by email or SMS or both, according to the patients’ preferences. The dietary telecoaching program included a module for diabetes mellitus, arterial hypertension, obesity and healthy diet. Cardiovascular risk factor profiling at the start of the study determined which module(s) were prescribed for each patient. Key to the diabetes mellitus module was the restriction of fast carbohydrates, energy rich nutrition and ethanol containing beverages. The arterial hypertension and obesity modules focused on salt restriction and energy intake reduction, respectively. Healthy diet included recommendations based on the food triangle. 6. Patients in the control group received the conventional centre-based cardiac rehabilitation program; including 45 pluridisciplinary rehabilitation sessions focusing on healthy diet, psychosocial wellbeing, behavioural change, risk factor modification and exercise training. They were instructed to wear the accelerometer at the start of the study, after 6 weeks and at the end of the study for comparison purposes only. The sensors were taped, making it impossible to see the registered physical activity data. The study nurses at the respective hospitals uploaded the data; patients were not given any access to the webpage with uploaded data. The control patients did not receive any physical activity, smoking cessation or dietary telecoaching by email or SMS.
Intervention type	Other
Primary outcome measure	Peak oxygen consumption (VO2 peak) at maximal cardiopulmonary exercise testing; measured at baseline, 6 weeks and 6-month follow-up
Secondary outcome measures	1. Daily physical activity: defined as the total number of daily low intensity and high intensity steps and registered during the whole study by accelerometry data (measured continuously with an accelerometer) 2. Cardiovascular risk factor control: body weight, blood pressure, blood lipids, glucose and glycated haemoglobin measured at baseline and 6-month follow-up 3. HeartQol: quality of life score measured at baseline, 6 weeks and 6-month follow-up 4. International Physical Activity Questionnaire: physical activity score measured at baseline, 6 weeks and 6 months 5. EQ-5D score measured at 6 weeks and 6 months 6. Days lost due to cardiovascular rehospitalisation from the start to the end of the study 7. Days lost due to hospitalisation for any reason from the start to the end of the study 8. Time to first cardiovascular rehospitalisation from the start to the end of the study 9. Time to first hospitalisation for any reason from the start to the end of the study
Overall study start date	01/02/2013
Completion date	01/02/2015

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	140
Total final enrolment	140
Key inclusion criteria	1. Coronary artery disease treated conservatively with percutaneous coronary intervention or coronary artery bypass graft 2. Chronic heart failure (CHF) with reduced ejection fraction (EF) 3. CHF and preserved EF 4. Current active rehabilitation in one of the recruiting centres 5. Patients with a personal computer with an internet connection 6. Age >18 and <80 7. Familiarity with the Dutch language 6. Patients who provided informed consent
Key exclusion criteria	1. Orthopaedic or neurological condition or both, restricting the patient’s ability to actively engage in exercise training sessions 2. Impairment preventing the use of the telerehabilitation equipment or attendance at follow-up visits (terminal disease, dementia and cognitive impairment) 3. Simultaneous participation in another clinical trial 4. CHF New York Heart Association class IV 5. History of ventricular fibrillation, exertional sustained ventricular tachycardia or supraventricular tachycardia within the previous 6 months
Date of first enrolment	25/02/2013
Date of final enrolment	25/08/2014

Locations

Countries of recruitment

Belgium

Study participating centres

Jessa Hospital

Stadsomvaart 11
3500 Hasselt
Hasselt
3500
Belgium

Ziekenhuis Oost-Limburg

Schiepse Bos 6
3600 Genk
Genk
3600
Belgium

St Franciscus Hospital

Pastoor Paquayaan 129
3550 Heusden-Zolder
Heusden-Zolder
3550
Belgium

Sponsor information

Flanders Care
Government

Koning Albert II-laan 35 bus 30
B-1030 Brussel
Brussel
1030
Belgium

"ROR"	https://ror.org/04qxsrb28

Funders

Funder type

Government

Fonds Wetenschappelijk Onderzoek
Government organisation / Local government

Alternative name(s): Research Foundation Flanders, Flemish Research Foundation, FWO
Location: Belgium

Yorbody

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Other
Publication and dissemination plan
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	07/05/2015		Yes	No
Results article	results	01/11/2017		Yes	No
Results article		23/07/2015	09/02/2023	Yes	No

Editorial Notes

09/02/2023: Publication reference and total final enrolment added.
20/09/2017: Publication reference added.