A personalized mHealth training application to increase physical activity during and after cardiac rehabilitation.

Despite strong recommendations (class 1) and health benefits of cardiac
rehabilitation (CR) programs, many patients lapse into a physically inactive
lifestyle within months after CR completion. A potential solution to change
this unhealthy behavior can be a more intense CR program, including a
combination of center-based exercise training and home-based exercise training.
Furthermore, prolongation of center-based CR (6 weeks exercise training in
usual care) with home-based CR (daily exercise instructions) could increase its
effect on habitual physical activity levels. The availability of mobile-health
(mHealth) interventions such as smartphone applications allow researchers and
clinicians to explore the health benefits of home-based CR on cardiovascular
risk factors and clinical outcomes.

Primary Objective:
The aim of the study is to assess the effect of an additional home-based
training module during CR and post-CR on physical activity levels among
coronary artery disease (CAD) patients.

Secondary Objective:
The secondary aim of the study is to compare the effects of an additional
home-based training module during CR and post-CR on total sitting time
(min/week), physical fitness (VO2), quality of life, cardiac anxiety score,
laboratory values, and cardiovascular risk scores among CAD patients.

Tertiary Objective:
To compare all-cause mortality, cardiovascular mortality, rehospitalisation and
recurrence of acute coronary syndromes between groups during 5 years of
follow-up.

In order to provide insight in the effectiveness of a additional home-based
training module on the physical activity levels in CAD patients, an 18 week
randomized controlled trial with 4 arms will be performed. Participants will
will be randomly assigned by an independent researcher to either:
1) CR 6 weeks center-based CR followed by 12 weeks usual care
2) CR+ 6 weeks center-based CR followed by 12 weeks home-based exercise
training
3) +CR 6 weeks center-based CR combined with home-based exercise
training followed by 12 weeks usual care
4) +CR+ 6 weeks center-based CR combined with home-based exercise
training followed by 12 weeks home-based exercise training.

Overview
In the first group (CR), participants will participate in the 6-week
center-based CR program (i.e. usual care). After completion of the program,
they will follow usual care (no intervention) during the 12 weeks of follow-up.
In the second group (CR+), participants will participate in a 6-week
center-based CR program (i.e. usual care). After completion of the center-based
program, participants receive 12 weeks of post-CR home-based training. The
third group (+CR) will participate in the 6-week center-based CR program
combined with a 6-week home-based training module. After the completion of the
6-week programs, participants will follow usual care (no intervention). The
fourth group (+CR+) will participate in the 6-week center-based CR program
combined with a 6-week home-based training module. After completion,
participants receive 12 weeks of post-CR home-based training.

Subjects in group 2(CR+), 3 (+CR) and 4(+CR+) will be asked to perform physical
activity in their home situation using a mHealth application called Virtual
Training® (introduction video: https://www.youtube.com/watch?v=uhgBoeEMbcI).
The application shows the different training programs and provides instructions
in the form of both video and text during the exercise. Figure 3 shows an
example of the interface of the application

Based on the participants preferences and status, a home-based training program
will be drafted by the treating physical therapist. An exercise program will
consist of 10-15 bodyweight exercises which patients can perform in their home
environment. Exercises are performed in 1-3 sets consisting of either 10-15
repetitions or are timebound (ranging from 30 to 120 seconds). Furthermore,
patients can record their walking and biking behaviour using the Virtual
Training® application. Subjects will be instructed to try to exercise daily
using the Virtual Training® application on a self-chosen moment.

During the center-based rehabilitation period (first 6 week), the intensity of
the program of the home-based exercises will be adjusted to the patient*s
status and level of physical activity. In the beginning, the exercise program
will consist of lighter exercises and longer breaks. Based on the individual
participants progression, intensity of exercises and total training program
will be increased over 6 weeks. In the 12-week follow-up groups (CR+ and +CR+),
intensity and frequency of the program can be adjusted in consultation between
the participants and physical therapist.

In the Virtual Training® application, patients can contact their treating
physical therapist by sending an in-application text. Questions regarding the
training program, exercises, execution or problems can be discussed at any
moment.

With the results of this study we hope to gain further insight into the
potential beneficial effects on physical activity of a center-based CR program
plus home-based CR. Risks as the result of participation in this study are
minimal. The home-based exercise program is of low to moderate intensity (both
aerobic and strengths exercises) making the possibilities of AE minimal. One
potential risk is that patients could experience muscle pain, although this is
risk is minimized by personalizing the exercise training part as much as
possible, so that participants receive a customized training incentive.
Participants in the home-based CR group could potentially benefit from an
improvement in their cardiovascular health. There are no notable risks of
participating in this study. According to the NFU risk classification
guidelines, the present study qualifies as being of *negligible risk* to the
participants since there is low likelihood of minor damage, low risks
associated with the specific population, low social risks to the participant,
and low risk associated with the research set-up and execution.