The purpose of this study is to evaluate the feasibility and the short-term effects of an early-start aerobic exercise training program on functional capacity, symptoms and neurohormonal activation in chronic heart failure patients with recent acute hemodynamic decompensation.
Prescription of aerobic exercise training in stable chronic heart failure patients finds an evidence-based justification in the acknowledged long-term positive effects of aerobic exercise training on both functional capacity and prognosis in this population. In recent time, evidence has accumulated in normal subjects about short-term favorable effects of aerobic exercise training on sympatho-vagal balance and flow-mediated vasodilation, two physiological mechanisms known to be profoundly altered in the setting of acute hemodynamic decompensation of chronic heart failure. The possible extension of aerobic exercise training indication to chronic heart failure patients admitted for recent acute hemodynamic decompensation not stabilized as yet, may thus provide a valuable, low-cost tool to effectively manage such a high-risk and resource-absorbing population.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
200
Days 1-2: active assisted mobilization (2 sessions/day, each 30 minutes duration). Days 3-4: as days 1-2 + unloaded bedside cycle ergometer (3 sessions/day, each 5-6 minutes duration). Days 5-6: as days 1-2 + bedside cycle ergometer at 10 W (3 sessions/day, each 15-20 minutes duration). Days 7-12: as days 1-2 + bedside cycle ergometer at 10-20 W (3 sessions/day, each 15-20 minutes duration). In addition, when possible according to their clinical conditions, patients will undergo one assisted ambulation session of 15-20 minutes per day.
Days 1-2: active assisted mobilization (2 sessions/day, each 30 minutes duration). Days 3-12: active assisted mobilization (1 session/day, 30 minutes duration). In addition, when possible according to their clinical conditions, patients will undergo one assisted ambulation session of 15-20 minutes per day.
Fondazione Salvatore Maugeri, IRCCS - Scientific Institute of Cassano Murge
Cassano Murge, Italy
RECRUITINGFondazione Salvatore Maugeri, IRCCS - Scientific Institute of Lumezzane
Lumezzane, Italy
RECRUITINGDistance walked at 6-min walking test
Change from baseline in distance walked at 6-min walking test
Time frame: 12 days of intervention
Aerobic exercise training safety and tolerability
Number of participants with serious/non-serious adverse events and completing/not completing the study protocol
Time frame: 12 days of treatment
Patient-reported dyspnea, evaluated by a 7-point Likert scale
Change from baseline in patient-reported dyspnea on a 7-point Likert scale
Time frame: 12 days of intervention
Levels of lymphocyte G protein-coupled receptor kinase-2
Change from baseline in lymphocyte G protein-coupled receptor kinase-2 levels
Time frame: 12 days of intervention
Levels of circulating inflammatory and angiogenetic markers (TNF-alfa, Interleukin-6, Angiopoietin 2 and VEGF)
Change from baseline in circulating inflammatory and angiogenetic markers (TNF-alfa, Interleukin-6, Angiopoietin 2 and VEGF) levels
Time frame: 12 days of intervention
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Fondazione Salvatore Maugeri - Scientific Institute of Milano
Milan, Italy
RECRUITINGFondazione Salvatore Maugeri, IRCCS - Scientific Institute of Montescano
Montescano, Italy
RECRUITINGFondazione Salvatore Maugeri, IRCCS - Scientific Institute of Pavia
Pavia, Italy
RECRUITINGFondazione Salvatore Maugeri, IRCCS - Scientific Institute of Telese Terme
Telese Terme, Italy
RECRUITINGFondazione Salvatore Maugeri - Presidio Major of Torino
Torino, Italy
RECRUITINGFondazione Salvatore Maugeri, IRCCS - Scientific Institute of Tradate
Tradate, Italy
RECRUITINGFondazione Salvatore Maugeri, IRCCS - Scientific Institute of Veruno
Veruno, Italy
RECRUITING