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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aerobic exercise training | Experimental |
| |
| Standard physical therapy | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aerobic exercise training | Other | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alessandro Mezzani, MD | Contact | +39-3403119299 | alessandro.mezzani@fsm.it | |
| Pantaleo Giannuzzi, MD | Contact | +39-0322-884812 | pantaleo.giannuzzi@fsm.it |
| Name | Affiliation | Role |
|---|---|---|
| Pantaleo Giannuzzi, MD | Fondazione Salvatore Maugeri - Scientific Institute of Veruno | Study Chair |
| Alessandro Mezzani, MD | Fondazione Salvatore Maugeri - Scientific Institute of Veruno | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione Salvatore Maugeri, IRCCS - Scientific Institute of Cassano Murge | Recruiting | Cassano Murge | 70020 | Italy |
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| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D004417 | Dyspnea |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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|
| Standard physical therapy | Other | 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. |
|
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 |
| Fondazione Salvatore Maugeri, IRCCS - Scientific Institute of Lumezzane | Recruiting | Lumezzane | 25066 | Italy |
|
| Fondazione Salvatore Maugeri - Scientific Institute of Milano | Recruiting | Milan | 20138 | Italy |
|
| Fondazione Salvatore Maugeri, IRCCS - Scientific Institute of Montescano | Recruiting | Montescano | 27040 | Italy |
|
| Fondazione Salvatore Maugeri, IRCCS - Scientific Institute of Pavia | Recruiting | Pavia | 27100 | Italy |
|
| Fondazione Salvatore Maugeri, IRCCS - Scientific Institute of Telese Terme | Recruiting | Telese Terme | 82037 | Italy |
|
| Fondazione Salvatore Maugeri - Presidio Major of Torino | Recruiting | Torino | 10124 | Italy |
|
| Fondazione Salvatore Maugeri, IRCCS - Scientific Institute of Tradate | Recruiting | Tradate | 21049 | Italy |
|
| Fondazione Salvatore Maugeri, IRCCS - Scientific Institute of Veruno | Recruiting | Veruno | 28010 | Italy |
|
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |