The primary objective of the study is to determine whether exercise training exerts a long term effect on maximal exercise capacity, clinical events, sports participation, serum NT-proBNP and quality of life in adults with a systemic right ventricle…
ID
Source
Brief title
Condition
- Congenital cardiac disorders
- Cardiac and vascular disorders congenital
- Lifestyle issues
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Maximal exercise capacity measured by cardiopulmonary exercise testing.
Secondary outcome
Health related quality of life
Serum NT-proBNP
Current exercise habits
Clinical events
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. Recently, we demonstrated that exercise training is also
beneficial in patients with a systemic right ventricle due to a surgically
corrected transposition of the great arteries (TGA) or a congenitally corrected
transposition of the great arteries (ccTGA). In this study, performed in 2009,
a ten week home based step aerobic exercise program increased maximal exercise
capacity.
However, it remains unclear whether this was only a temporary effect for the
duration of the exercise program, or whether exercise training also exerted a
long term effect. Moreover, engaging in habitual exercise in research setting
might have prompted participants to engage in sport or increase their exercise
frequency. Finally, as exercise training decreases mortality and morbidity in
patients with acquired heart disease, this might also be the case in patients
with a systemic right ventricle.
Study objective
The primary objective of the study is to determine whether exercise training
exerts a long term effect on maximal exercise capacity, clinical events, sports
participation, serum NT-proBNP and quality of life in adults with a systemic
right ventricle due to a surgically or congenitally corrected TGA.
Study design
Three year follow-up of randomized controlled trial. Single crosssectional
re-evaluation of all participants
Study burden and risks
Patients are requested for a one-time visit to the hospital for additional
follow-up examinations. These include a cariopulmonary exercise test, two
questionnaires, an interview concerning their current exercise habits and
venapunction.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
Patients with a systemic right ventricle due to a congenitally or atrially corrected traonsposition of the great arteries, who participated in the 2009 exercise trial.
Exclusion criteria
- Cardiac and/or non-cardiac co-morbidity that may jeopardize patient safety during cardiopulmonary exercise testing.
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 | NL41508.018.12 |