Exercise training improves exercise capacity in adult patients with a systemic right ventricle: a randomized clinical trial.
OBJECTIVE
To assess whether exercise training in adult patients with a systemic right ventricle (RV) improves exercise capacity and quality of life and lowers serum N-terminal prohormone brain natriuretic peptide (NT-proBNP) levels.


METHODS
Multi-centre parallel randomized controlled trial.


METHODS
Patients with a systemic RV due to congenitally or surgically corrected transposition of the great arteries.


METHODS
Fifty-four adult patients with a systemic RV, were randomized using unmarked opaque envelopes to an intervention group (n = 28) with three training sessions per week for 10 consecutive weeks, and a control group (n = 26). Randomization was stratified by participating centre. At baseline, and follow-up, we determined maximal exercise capacity (V'O(2peak)), serum NT-proBNP levels, and quality of life by means of the SF-36, and the TAAQOL Congenital Heart Disease questionnaires. The final analysis was performed by linear regression, taking into account the stratified randomization.


RESULTS
Forty-six patients were analysed (male 50%, age 32 ± 11 years, intervention group n = 24, control group n = 22). Analysis at 10 weeks showed a significant difference in V'O(2peak) (3.4 mL/kg/min, 95% CI: 0.2 to 6.7; P = 0.04) and resting systolic blood pressure (-7.6 mmHg, 95% CI: -14.0 to -1.3; P = 0.03) in favour of the exercise group. No significant changes were found in serum NT-proBNP levels or quality of life in the intervention group or in the control group nor between groups. None of the patients in the intervention group had to discontinue the training programme due to adverse events.


CONCLUSIONS
In adult patients with a systemic RV exercise training improve exercise capacity. We recommend to revise restrictive guidelines, and to encourage patients to become physically active. (


BACKGROUND
The study was registered at http://trialregister.nl. Identifier: NTR1909.).
Department of Cardiology, Academic Medical Center, Meibergdreef 9, Amsterdam, The Netherlands.
Michiel M
MM
Winter
Teun
T
van der Bom
Leonie C S
LC
de Vries
Anna
A
Balducci
Berto J
BJ
Bouma
Petronella G
PG
Pieper
Arie P J
AP
van Dijk
Mart N
MN
van der Plas
Fernando M
FM
Picchio
Barbara J M
BJ
Mulder
D000328:Adult; D000080041:Congenitally Corrected Transposition of the Great Arteries; D005081:Exercise Therapy; D017079:Exercise Tolerance / Q000502:physiology*; D005260:Female; D006801:Humans; D008297:Male; D020097:Natriuretic Peptide, Brain / Q000378:metabolism; D010446:Peptide Fragments / Q000378:metabolism; D011446:Prospective Studies; D011788:Quality of Life; D014188:Transposition of Great Vessels / Q000097:blood / Q000503:physiopathology*; D016896:Treatment Outcome; D018497:Ventricular Dysfunction, Right / Q000097:blood / Q000503:physiopathology / Q000628:therapy*; D055815:Young Adult
D010446:Peptide Fragments; C109794:pro-brain natriuretic peptide (1-76); D020097:Natriuretic Peptide, Brain