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Exercise training improves exercise capacity in adult patients with a systemic right ventricle: a randomized clinical trial
Winter MM, van der Bom T, de Vries LCS, Balducci A, Bouma BJ, Pieper PG, van Dijk APJ, van der Plas MN, Picchio FM, Mulder BJM
European Heart Journal 2012 Jun;33(11):1378-1385
clinical trial
7/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: Yes; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

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. DESIGN Multi-centre parallel randomized controlled trial. PARTICIPANTS 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 (VO2peak), 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 VO2peak (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. CONCLUSION 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. (TRIAL REGISTRATION: The study was registered at http://trialregister.nl. identifier NTR1909).
For more information on this journal, please visit http://www.harcourt-international.com/journals/EUHJ.

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