The aim of the present study is to evaluate the effect of exercise training on exercise capacity, serum NT-proBNP levels and quality of life in adult patients with a systemic right ventricle.
ID
Source
Brief title
Condition
- Congenital cardiac disorders
- Cardiac and vascular disorders congenital
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study parameter is to determine whether exercise training improves
maximal exercise capacity in adult patient with a systemic right ventricle.
Secondary outcome
The secondary study parameters are to determine whether exercise training a).
improves health related quality of life and b). decreases serum NT-proBNP
levels in adult patients with adult a systemic right ventricle.
Background summary
The American Heart Association recommends patients with acquired heart disease
to participate in exercise training. Exercise training improves exercise
capacity and quality of life in these patients, and it also decreases morbidity
and mortality. Despite these improvements seen with exercise training in
patients with acquired heart disease, available data on the effect of exercise
in adult patients with congenital heart disease are limited.
However, the prevalence of adult patients with a congenital heart defect has
increased steadily over the last decades. A substantial portion of these
patients has a morphologic RV supporting the systemic circulation (e.g.
patients with congenitally corrected transposition of the great arteries
(ccTGA) and patients with complete transposition of the great arteries (TGA)
after an atrial switch operation). Complications are frequent and long-term
survival is comprised in these patients, mostly due to the inevitable
deterioration of systemic RV function.
Currently, a large number of patients with a systemic right ventricle lead a
sedentary lifestyle caused by overprotection by their parents and physicians.
Moreover, lack of available literature on exercise in these patients has lead
to restrictive European recommendations on exercise and sports participation.
The reticence toward exercise could have unintentional counterproductive
effects. It has been proven that physical training has a beneficial effect in
children with congenital heart defects, both on exercise capacity and on a
psychosocial level. These results could well be applicable to adult patients
with a systemic RV.
Study objective
The aim of the present study is to evaluate the effect of exercise training on
exercise capacity, serum NT-proBNP levels and quality of life in adult patients
with a systemic right ventricle.
Study design
Multi-centre, prospective, randomised trial with blinded evaluation of patient
outcomes. Follow-up ten weeks.
Intervention
One group participates in a home-based exercise program for the duration of ten
weeks. One group does not undergo intervention.
Study burden and risks
Patients are enrolled in an exercise training program. The training program is
commenced directly after the cardiopulmonary exercise test, with the first
exercise scheduled two days after the cardiopulmonary exercise test. Patients
are requested to perform physical exercise at home, climbing stairs, three
times a week for 10 consecutive weeks. The duration of each training session is
set at 40 minutes (5 min warm-up, 30 min training, 5 min cool-down).
We consider the risks of participation to be low. Maximal exercise capacity is
evaluated at baseline during the cardiopulmonary exercise test. Symptomatic
patients (at rest or during the exercise test) are excluded from the study (see
exclusion criteria for details).
Meibergdreef 9
1105 AZ Amsterdam
Nederland
Meibergdreef 9
1105 AZ Amsterdam
Nederland
Listed location countries
Age
Inclusion criteria
systemic right ventricle
Exclusion criteria
- Mental incapability to give informed consent
- Mental or physical incapability to participate in the exercise training program
- Exercise-induced arrhythmias
- Symptomatic myocardial ischemia
- Resting systolic blood pressure > 200 mmHg and/or diastolic blood pressure > 110 mmHg.
- NYHA class III or IV
- Severe aortic valve stenosis
- Non-cardiac co-morbidity that may affect exercise performance or that may aggravate by exercise (e.g. infection, renal failure)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL25630.018.08 |