Chronic Heart Failure, Heart Decompensation
Conditions
Keywords
Chronic heart failure, Heart decompensation, Aerobic exercise training, Functional capacity, Dyspnea, Beta-adrenergic receptor signaling
Brief summary
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.
Detailed description
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.
Interventions
OTHERAerobic exercise training
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.
OTHERStandard physical therapy
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.
Sponsors
Fondazione Salvatore Maugeri
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* history of chronic heart failure for at least 6 months, with ongoing acute decompensation defined as onset or worsening of heart failure signs and/or symptoms during the previous 15 days with need of intravenous diuretic and/or vasodilator therapy; * age \>18 years * left ventricular ejection fraction \<40% * proBNP \>1000 pg/ml at admission
Exclusion criteria
* ongoing cardiogenic shock * need of intravenous inotropic therapy * acute coronary syndrome during the preceding 3 months * clinical and/or instrumental evidence of myocardial ischemia and/or life-threatening arrhythmias * previous cardiac valve surgery * creatinine \>2.5 mg/dl at admission * severe comorbidities limiting functional capacity
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Distance walked at 6-min walking test | 12 days of intervention | Change from baseline in distance walked at 6-min walking test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Aerobic exercise training safety and tolerability | 12 days of treatment | Number of participants with serious/non-serious adverse events and completing/not completing the study protocol |
| Patient-reported dyspnea, evaluated by a 7-point Likert scale | 12 days of intervention | Change from baseline in patient-reported dyspnea on a 7-point Likert scale |
| Levels of lymphocyte G protein-coupled receptor kinase-2 | 12 days of intervention | Change from baseline in lymphocyte G protein-coupled receptor kinase-2 levels |
| Levels of circulating inflammatory and angiogenetic markers (TNF-alfa, Interleukin-6, Angiopoietin 2 and VEGF) | 12 days of intervention | Change from baseline in circulating inflammatory and angiogenetic markers (TNF-alfa, Interleukin-6, Angiopoietin 2 and VEGF) levels |
Countries
Italy
Contacts
Primary ContactAlessandro Mezzani, MD
Backup ContactPantaleo Giannuzzi, MD
Outcome results
None listed