Effects of homebased training with telemonitoring guidance in low to moderate risk patients entering cardiac rehabilitation

Physical training has beneficial effects on exercise capacity, cardiac
function, quality of life and mortality in patients with acute cardiovascular
syndrome or after cardiac surgery and is therefore one of the main aspects of
cardiac rehabilitation. However, adherence to this therapy is low and effects
tempt to decrease directly after the treatment period.

The objective of the present study is to investigate whether home-based
exercise training with telemonitoring guidance results in improved long-term
physical fitness and higher activity levels than regular centre-based exercise
training in patients after an ACS or revascularization procedure with a low to
moderate risk of further events. Furthermore, both training strategies will be
compared with respect to training adherence (during the first 12 weeks),
health-related quality of life, patient satisfaction and their relative
cost-effectiveness. In a systematic review and meta-analysis published in 2010,
home-based training was shown to be equally effective as centre-based training
in low-to-moderate risk CR patients.However, the included studies did not apply
telemonitoring guidance and in most studies training data could not be reviewed
and used to instruct and motivate patients. We hypothesize that telemonitoring
guidance using objective training data during the initial rehabilitation period
will increase motivation and self-efficacy for independent exercise in CR
patients on the longer term (i.e. 1 year after the index event/intervention),
eventually resulting in a superior increase in physical fitness and physical
activity levels as compared to a traditional centre-based CR program. From a
cost perspective, we expect that the investments in monitoring devices and ICT
services are compensated for by lower direct medical costs in the home-based
training group due to fewer supervised exercise training sessions.

This study is designed as a monocentre randomized controlled trial among low to
moderate risk post- ACS and -revascularization patients at Máxima Medical
Centre, a large non-university teaching hospital. All patients referred for CR
at Máxima Medical Centre are evaluated at the outpatient clinic first. During
this intake procedure, the contents of the CR program is determined based on an
individual needs assessment. All patients with an indication for exercise
training meeting in and exclusion criteria are asked to participate and receive
verbal and written patient information about the study at the end of the intake
procedure. All other treatment modalities take place at the hospital as usual
(e.g. education therapy, lifestyle change therapy, and/or relaxation and stress
management training). After 1 week patients are contacted by the coordinating
investigator. If they consent to participate, they are asked to complete and
sign the informed consent form. During the first week of the study, all
included patients undergo baseline measurements, consisting of maximal exercise
testing with respiratory gas analysis on a cycle ergometer and assessment of
the physical activity level by continuous accelerometry and heart rate
measurement during a 5-day period. Subsequently patients will be randomized in
a 1:1 ratio using sealed envelopes. One group will be allocated to home-based
training (HT) with telemonitoring guidance (n=45), the other group to a common
12-week centre-based program (CT, n=45). Due to the nature of the intervention,
it is not possible to blind either patients or their caregivers to allocation.
In both groups patients receive further instructions during the first session
at the department of physical therapy. Maximal exercise testing with gas
analysis and continuous physical activity assessment will be repeated after the
training period of 12 weeks, and again after 1 year.
A subgroup of 20 patients will also participate in a sub study: modelling of
energy expenditure in cardiac rehabilitation patients. This study aims to
develop a model which can be used to assess Physical Activity Energy
Expenditure reliably in cardiac rehabilitation patients by using heart rate and
accelerometry data. These patients will undergo mobile oxygen uptake
measurements with simultaneous heart rate and accelerometry assessment at rest
and during several activities of low-to-moderate intensity.
A subgroup of 20 patients will participate in a second sub study: exit
interviews with FIT@Home participants. Ten patients from each group will be
interviewed after the last their last measurement of physical fitness. Each
interview will take approximately 45 minutes and is performed to identify the
strengths and weaknesses of the research protocol.

In the intervention, the first three training sessions of cardiac
rehabilitation will be performed in the hospital under direct supervision of a
physical therapist. During these sessions they will be familiarized with
training duration and intensity and they will be instructed on how to use the
wearable HR monitoring device in order to achieve their personal training
targets. In addition, patients are asked about their preferred training
modality in their home environment (e.g. cycling, walking/running, workout at
health club), and, if needed, given advice on how to implement this. Patients
are instructed to wear the HR monitoring device during training sessions and to
upload their recorded HR data to an online platform (Garmin Connect). Garmin
Connect can be used by patients to review their training data graphically and
to relate these to their personal goals (training duration and frequency
targets as well as HR target zones are entered in advance through the Garmin
Connect Dashboard). Training data are also accessed through Garmin Connect by
an exercise specialist (ES), a physical therapist specialized in CR, on a
weekly basis. During the training program, the ES will contact subjects by
telephone every week, providing feedback on training frequency, duration and %
of training within the HR target zone. Patients are also informed on the
possibility to exchange training data with other participants or family/friends
either through the Garmin Connect Dashboard or through a connection of their
Garmin account with social media (Facebook, LinkedIn, Twitter, Google). For
privacy reasons, access to their training data is only possible with their
explicit permission. Also the ES will no longer have access to the training
data after the training period. Patients themselves however have the
possibility, and are encouraged to continue using their Garmin account. To
obtain insight in the subjective experiences of data sharing, a sample of
patients will be interviewed after the training period on their data exchange
behavior.

The present study will focus on cardiac patients entering outpatient CR after
an ACS or a revascularization procedure with a low to moderate risk of further
events. As the intervention comprises home-based training during the early
rehabilitation period, high risk patients will not be included (e.g. patients
with symptomatic heart failure, complex congenital heart disease, severe
depression, arrhythmia*s or co-morbidity).

Exercise training performed by post-ACS and revascularization patients,
classified as low to moderate risk, is considered to be safe. In order to
reduce potential risks of exercise training all patients perform a maximal
cardiopulmonary exercise test at baseline, excluding patients with myocardial
ischaemia and ventricular arrhythmias during exercise. The first three training
sessions will be under supervision of trained physiotherapist in a clinical
setting. During those three meetings they will be counselled regarding training
modality, the heart rate sensor and safety. Patients can contact the
rehabilitation centre or general practitioner if they experience any symptoms
during exercise. If preferred, patients can always stop with the home-based
intervention and the study protocol and resume regular supervised
rehabilitation without consequences.