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Effect of moderate-intensity exercise training on peak oxygen consumption in patients with hypertrophic cardiomyopathy: a randomized clinical trial [with consumer summary]
Saberi S, Wheeler M, Bragg-Gresham J, Hornsby W, Agarwal PP, Attili A, Concannon M, Dries AM, Shmargad Y, Salisbury H, Kumar S, Herrera J, Myers J, Helms AS, Ashley EA, Day SM
JAMA 2017 Apr 4;317(13):1349-1357
clinical trial
6/10 [Eligibility criteria: No; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: No; 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*

IMPORTANCE: Formulating exercise recommendations for patients with hypertrophic cardiomyopathy is challenging because of concern about triggering ventricular arrhythmias and because a clinical benefit has not been previously established in this population. OBJECTIVE: To determine whether moderate-intensity exercise training improves exercise capacity in adults with hypertrophic cardiomyopathy. DESIGN, SETTING, AND PARTICIPANTS: A randomized clinical trial involving 136 patients with hypertrophic cardiomyopathy was conducted between April 2010 and October 2015 at 2 academic medical centers in the United States (University of Michigan Health System and Stanford University Medical Center). Date of last follow-up was November 2016. INTERVENTIONS: Participants were randomly assigned to 16 weeks of moderate-intensity exercise training (n = 67) or usual activity (n = 69). MAIN OUTCOMES AND MEASURES: The primary outcome measure was change in peak oxygen consumption from baseline to 16 weeks. RESULTS: Among the 136 randomized participants (mean age 50.4 (SD 13.3) years; 42% women), 113 (83%) completed the study. At 16 weeks, the change in mean peak oxygen consumption was +1.35 (95% CI 0.50 to 2.21) mL/kg/min among participants in the exercise training group and +0.08 (95% CI -0.62 to 0.79) mL/kg/min among participants in the usual-activity group (between-group difference 1.27 (95% CI 0.17 to 2.37); p = 0.02). There were no occurrences of sustained ventricular arrhythmia, sudden cardiac arrest, appropriate defibrillator shock, or death in either group. CONCLUSIONS AND RELEVANCE: In this preliminary study involving patients with hypertrophic cardiomyopathy, moderate-intensity exercise compared with usual activity resulted in a statistically significant but small increase in exercise capacity at 16 weeks. Further research is needed to understand the clinical importance of this finding in patients with hypertrophic cardiomyopathy, as well as the long-term safety of exercise at moderate and higher levels of intensity. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT01127061.

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