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EaRly-start ExerciSe training afTer acute hemodynAmic decompensation in patients with chRonic hearT failure (RE-START). A multicenter, randomized, controlled trial on short-term feasibility and impact on functional capacity, symptoms and neurohumoral activation |
Mezzani A, Cacciatore F, Catanzaro R, Gualco A, Guzzetti D, Leosco D, Monelli M, Tarro Genta F, Totaro P, Traversi E, Zanelli E, Giannuzzi P |
Monaldi Archives for Chest Disease 2014 Mar;82(1):20-22 |
clinical trial |
1/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: No; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: No; Intention-to-treat analysis: No; Between-group comparisons: No; Point estimates and variability: No. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed* |
RE-START is a multicenter, randomized, prospective, open, controlled trial aiming to evaluate the feasibility and the short- and medium-term effects of an early-start AET program on functional capacity, symptoms and neurohormonal activation in chronic heart failure (CHF) patients with recent acute hemodynamic decompensation. Study endpoints will be: (1) safety of and compliance to AET; (2) effects of AET on (i) functional capacity, (ii) patient-reported symptoms and (iii) AET-induced changes in beta-adrenergic receptor signaling and circulating angiogenetic and inflammatory markers. Two-hundred patients, randomized 1:1 to training (TR) or control (C), will be enrolled. Inclusion criteria: (1) history of systolic CHF for at least 6 months, with ongoing acute decompensation with need of intravenous diuretic and/or vasodilator therapy; (2) proBNP > 1,000 pg/mI at admission. Exclusion criteria: (1) ongoing cardiogenic shock; (2) need of intravenous inotropic therapy; (3) creatinine > 2.5 mg/dl at admission. After a 72-hour run-in period, TR will undergo the following 12-day early-start AET protocol: days 1 to 2: active/passive mobilization (2 sessions/day, each 30 minutes duration); days 3 to 4: as days 1 to 2 plus unloaded bedside cycle ergometer (3 sessions/day, each 5 to 10 minutes duration); days 5 to 8: as days 1 to 2 plus unloaded bedside cycle ergometer (3 sessions/day, each 15 to 20 minutes duration); days 9 to 12: as days 1 to 2 plus bedside cycle ergometer at 10 to 20 W (3 sessions/day, each 15 to 20 minutes duration). During the same period, C will undergo the same activity protocol as in days 1 to 2 for TR. All patients will undergo a 6-min WT at day 1, 6, 12 and 30 and echocardiogram, patient-reported symptoms on 7-point Likert scale and measurement of lymphocyte G protein coupled receptor kinase, VEGF, angiopoietin, TNF alfa, IL-1, IL-6 and eNOS levels at day 1, 12 and 30.
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