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Trial registered on ANZCTR


Registration number
ACTRN12618001170213
Ethics application status
Approved
Date submitted
21/06/2018
Date registered
16/07/2018
Date last updated
13/03/2019
Date data sharing statement initially provided
5/12/2018
Date results information initially provided
13/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Cardiovascular rehabilitation and telemedicine technology.
Scientific title
Development and feasibility of cardiovascular rehabilitation based on telemedicine technology (CR-GPS).
Secondary ID [1] 295269 0
NIG02/16
Universal Trial Number (UTN)
Trial acronym
CR-GPS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
coronary artery disease
308676 0
Condition category
Condition code
Physical Medicine / Rehabilitation 307429 307429 0 0
Physiotherapy
Cardiovascular 307430 307430 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The aim of this study is to evaluate the effects of a home-based cardiac training (HT) using the Global Positioning System and a regular outpatient training (ROT) on patient´s physical fitness. Secondary outcomes are patient´s adherence to training and quality of life.

Randomized controlled trial.
Patients are randomized into an HT group (n-28) and a ROT group (n-28). The evaluation is performed at the beginning of the rehabilitation cycle and 12 weeks later. It is based on maximum spiro-ergometric examination and quality of life described by patients in a questionnaire.
The target group of this study are patients with ischemic heart disease with re-vascularisation, without significant cardiovascular risk, participating in II. phase of cardiovascular rehabilitation.

HT group
In the HT group, rehabilitation training is conducted in the patient's home conditions using modern technology to transfer medical data remotely – the participants receive a wrist-sport tester to monitor heart rate and training values. To know what to do and how to train the first two training courses will be controlled by the physiotherapist in a cardiovascular rehabilitation clinic in the hospital, who creates individual training to each patient.
The patient's training data will be downloaded and updated regularly via Internet connection and clinicians will evaluate these results and provide patients with feedback, motivation and support them.
Web application can be used as a training diary – participants can control their previous data and follow the training process.
A training session in HT group consists of:
1. part – warm up – 10 minutes
2. part – aerobic phase – 60 minutes (according to predefined training heart frequency, including walking or cycling)
3. part – cool down – 10 minutes
Training period is set to 60 minutes per one session 3 times a week for 12 weeks, individualised according to heart rate reserve (set at 70 – 80%) of each participant.

Intervention code [1] 301603 0
Rehabilitation
Intervention code [2] 301604 0
Prevention
Intervention code [3] 301605 0
Lifestyle
Comparator / control treatment
ROT group
Participants in a regular outpatient training undergo an exercise workout period under the direct supervision of a physiotherapist specializing in cardiovascular rehabilitation. The participants will train on cycle ergometers and treadmills.
A training session in ROT group consists of:
1. part – warm up – 10 minutes
2. part – aerobic phase – 60 minutes (according to predefined training heart frequency, including cycling on ergometers and walking on treadmill)
3. part – cool down – 10 minutes
Training period is set to 60 minutes per one session 3 times a week for 12 weeks, individualised according to heart rate reserve (set at 70 – 80%) of each participant. Each training session will be monitored, recorded and later evaluated by the physiotherapist.

Control group
Active

Outcomes
Primary outcome [1] 306398 0
Change in physical performance (defined by peak oxygen consumption - VO2max, assessed from an incremental maximal bicycle spiro-ergometer exercise test)
Timepoint [1] 306398 0
baseline and 12-weeks
Secondary outcome [1] 348381 0
Health related quality of life (assessed by SF-36 questionnaire)
Timepoint [1] 348381 0
baseline and 12-weeks
Secondary outcome [2] 348938 0
Training adherence (total number of training sessions assessed via web application in HT group and session attendance checklist in ROT group)
Timepoint [2] 348938 0
12-weeks

Eligibility
Key inclusion criteria
Patients:
-with ischemic heart desease after myocardial revascularization (15-60 days)
-entering II. phase of cardiovascular rehabilitation at University hospital in Brno, Czech Republic.
-with the possibility of mobile or basic internet connection at home
-without significant cardiovascular risk
-signed written informed consent
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients:
-with contraindication to cardiovacular rehabilitation
-with potencialy high cardiovascular risk
-with implanted cardioverter-defibrilator or pacemaker
-with residual parcial coronary arethery stenosis requiring revascularization
-with orthopedic or neurological disability to exercise
-with mental disadvantage making cooperation impossible
-with impossibility of an Internet connection

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 10578 0
Czech Republic
State/province [1] 10578 0
Jizni Morava

Funding & Sponsors
Funding source category [1] 299858 0
Government body
Name [1] 299858 0
Ministry of Health Czech Republic
Address [1] 299858 0
Ministry of Health Czech Republic
Palackého nám. 4
128 01 Prague
Country [1] 299858 0
Czech Republic
Primary sponsor type
Hospital
Name
University Hospital Brno
Address
University Hospital Brno
Jihlavska 20,
Brno, 62500,
Czech Republic
Country
Czech Republic
Secondary sponsor category [1] 299212 0
None
Name [1] 299212 0
none
Address [1] 299212 0
Country [1] 299212 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300734 0
Ethical Commission of the University Hospital Brno
Ethics committee address [1] 300734 0
Ethical Commission of the University Hospital Brno
Jihlavská 20
625 00 Brno
Czech Republic
Ethics committee country [1] 300734 0
Czech Republic
Date submitted for ethics approval [1] 300734 0
31/05/2016
Approval date [1] 300734 0
08/06/2016
Ethics approval number [1] 300734 0

Summary
Brief summary
Regular cardiac activity is an obvious method of rehabilitation and secondary prevention of cardiovascular disease. Cardiac attendance in motion programs is low. One way to improve patient participation is to use telemedicine technology. The aim of this study is to assess the effects of home cardiac training using the telemedicine method and regular outpatient training.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2797 2797 0 0

Contacts
Principal investigator
Name 84634 0
Mr Ladislav Batalik
Address 84634 0
University Hospital Brno
Jihlavska 20
62500
Brno
Czech Republic
Country 84634 0
Czech Republic
Phone 84634 0
+420532233123
Fax 84634 0
Email 84634 0
batalik86@gmail.com
Contact person for public queries
Name 84635 0
Dr Filip Dosbaba
Address 84635 0
University Hospital Brno
Jihlavska 20
62500
Brno
Czech Republic
Country 84635 0
Czech Republic
Phone 84635 0
+42053323442
Fax 84635 0
Email 84635 0
dosbaba.filip@fnbrno.cz
Contact person for scientific queries
Name 84636 0
Dr Filip Dosbaba
Address 84636 0
University Hospital Brno
Jihlavska 20
62500
Brno
Czech Republic
Country 84636 0
Czech Republic
Phone 84636 0
+42053323442
Fax 84636 0
Email 84636 0
dosbaba.filip@fnbrno.cz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
Study protocol
Attachments/websites
Type [1] 612 0
Study protocol
URL/details/comments [1] 612 0
https://journals.lww.com/md-journal/fulltext/2018/09140/Rationale_and_design_of_randomized_controlled.82.aspx
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary