Early-start Exercise Training in Subacute Heart Failure

Study Overview
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Brief Summary
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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
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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.

Official Title
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Early-start Exercise Training After Acute Hemodynamic Decompensation in Patients With Chronic Heart Failure. A Multicenter, Randomized, Controlled Trial on Feasibility and Impact on Functional Capacity, Symptoms and Neurohumoral Activation.

Conditions
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Chronic Heart Failure, Heart Decompensation

Intervention / Treatment
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* Other: Aerobic exercise training
* Other: Standard physical therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aerobic exercise training<br> | Other: Aerobic exercise training<br>* 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.<br>|
| Active Comparator: Standard physical therapy<br> | Other: Standard physical therapy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distance walked at 6-min walking test | Change from baseline in distance walked at 6-min walking test | 12 days of intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aerobic exercise training safety and tolerability | Number of participants with serious/non-serious adverse events and completing/not completing the study protocol | 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 | 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 | 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 | 12 days of intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic heart failure, Heart decompensation, Aerobic exercise training, Functional capacity, Dyspnea, Beta-adrenergic receptor signaling