Exercise Training in Grown-Up Congenital Heart Disease.

Survival of patients with congenital heart disease has steadily increased over
the past decades, with even those with severe congenital cardiac anomalies
currently reaching adulthood. Many patients have residual lesions of their
cardiac condition, which, in addition to previous cardiac surgery and cyanosis
during childhood, increases their risk to develop heart failure. In patients
with acquired heart failure regular physical
activity decreases both (cardiac) morbidity and mortality. Although the
rationale behind the beneficial effects of physical activity seems equally
applicable to grown-up congenital heart disease (GUCH) patients, no conclusive
evidence exists.

Our previous, small-scaled pilot-study on exercise training in adult patients
with a systemic right ventricle demonstrated an increase in exercise capacity
after a 10-week training program. In addition, exercise training was found to
be safe, even in these complex cardiac patients. Indeed, it seems highly likely
that exercise training will lead to substantial improvements in
(cardiovascular) morbidity in a much broader spectrum of
GUCH patients.

Exercise training studies in acquired heart disease showed that compliance is a
pitfall. To overcome this pitfall, we hypothesized that a training program
should be patient-based. More importantly, by mutual contact through social
media we assume patients to remain involved and motivated. Therefore, we
propose the *ExTra GUCH trial*, as a large-scale, randomized controlled trial,
to evaluate the effect of sports participation on exercise capacity, morbidity
and quality of life in symptomatic GUCH patients. We expect our study to
provide evidence of the benefits of exercise training in GUCH patients, so to
provide these young patients with the best possible cardiovascular care. In
addition, the study will give insight into the
expanding role of social media in cardiovascular care.

The objective of the study is to evaluate the effect of physical exercise on
exercise capacity, quality of life and serum NT-proBNP levels in adult patients
with congenital heart disease.

Multi-centre, prospective, randomised trial with blinded evaluation of patient
outcomes. Follow-up 26 weeks.

The ExTra GUCH training protocol is designed to decrease participation
threshold, and increase patient*s ownership. Consenting patients agree with
sports participation three times per week, for 26 consecutive weeks (e.g. six
months). The training schedule is set-up as follows:

Training sessions are individualized, based on the mean heart rate reserve (HRR
= resting heart rate + 0.6[peak heart rate - resting heart rate]) of the HRR at
latest cardiopulmonary exercise test. This ensures optimal individualized
training schedules, and takes into account any possible use of medication. Each
training session takes a minimum of thirty minutes. Patients are requested to
keep a log for the training program, stating dates and times of performed
exercise, and heart rates during exercise.

Previous exercise training studies in acquired heart disease showed that
compliance is a pitfall. To overcome this pitfall two major differences are
incorporated into our study. Firstly, consenting patients can choose their
sport to perform the exercise-training program as they like, as long as the
above mentioned time-criteria are met.

Social media
Secondly, to increase compliance and create solidarity, consenting patients are
added to the enclosed ExTra GUCH Facebook group. The ExTra GUCH Facebook group
is designed to post sportive accomplishments, and study progress. Consenting
patients can post questions, which can be answered by fellow participants, or
the principal investigator. No clinical and/or private information is posted on
the ExTra GUCH Facebook group. The principal investigator manages the ExTra
GUCH Facebook group. Participation in the ExTra GUCH Facebook group is
voluntary, and refusal to participate does not exclude consenting patients from
participation in the trial.

Patients can cease the exercise training at any time and for any reason without
consequences for the patient*s further treatment.

Previous studies on exercise in adult patients with congenital heart disease
showed exercise to be safe in this patient population. Exercise related
injuries are to be expected. Although no (major) cardiovascular events are
expected from the proposed study, all events will be noted.