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Early-start Exercise Training in Subacute Heart Failure

NCT ID: NCT02051985

Last Updated: 2014-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2015-09-30

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.

Conditions

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Chronic Heart Failure Heart Decompensation

Keywords

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Chronic heart failure Heart decompensation Aerobic exercise training Functional capacity Dyspnea Beta-adrenergic receptor signaling

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Aerobic exercise training

Group Type EXPERIMENTAL

Aerobic exercise training

Intervention Type 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.

Standard physical therapy

Group Type ACTIVE_COMPARATOR

Standard physical therapy

Intervention Type 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.

Interventions

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Aerobic 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.

Intervention Type OTHER

Standard 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.

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondazione Salvatore Maugeri

OTHER

Sponsor Role lead

Responsible Party

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Alessandro Mezzani

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Pantaleo Giannuzzi, MD

Role: STUDY_CHAIR

Fondazione Salvatore Maugeri - Scientific Institute of Veruno

Alessandro Mezzani, MD

Role: PRINCIPAL_INVESTIGATOR

Fondazione Salvatore Maugeri - Scientific Institute of Veruno

Locations

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Fondazione Salvatore Maugeri, IRCCS - Scientific Institute of Cassano Murge

Cassano Murge, , Italy

Site Status RECRUITING

Fondazione Salvatore Maugeri, IRCCS - Scientific Institute of Lumezzane

Lumezzane, , Italy

Site Status RECRUITING

Fondazione Salvatore Maugeri - Scientific Institute of Milano

Milan, , Italy

Site Status RECRUITING

Fondazione Salvatore Maugeri, IRCCS - Scientific Institute of Montescano

Montescano, , Italy

Site Status RECRUITING

Fondazione Salvatore Maugeri, IRCCS - Scientific Institute of Pavia

Pavia, , Italy

Site Status RECRUITING

Fondazione Salvatore Maugeri, IRCCS - Scientific Institute of Telese Terme

Telese Terme, , Italy

Site Status RECRUITING

Fondazione Salvatore Maugeri - Presidio Major of Torino

Torino, , Italy

Site Status RECRUITING

Fondazione Salvatore Maugeri, IRCCS - Scientific Institute of Tradate

Tradate, , Italy

Site Status RECRUITING

Fondazione Salvatore Maugeri, IRCCS - Scientific Institute of Veruno

Veruno, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Alessandro Mezzani, MD

Role: CONTACT

Phone: +39-3403119299

Email: [email protected]

Pantaleo Giannuzzi, MD

Role: CONTACT

Phone: +39-0322-884812

Email: [email protected]

Facility Contacts

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Raffaella Catanzaro, MD

Role: primary

Francesca Rivadossi, MD

Role: primary

Paolo Totaro, MD

Role: primary

MD

Role: backup

Egidio Traversi, MD

Role: primary

Alessandra Gualco, MD

Role: primary

Francesco Cacciatore, MD

Role: primary

Franco Tarrogenta, MD

Role: primary

Daniela Guzzetti, MD

Role: primary

Alessandro Mezzani, MD

Role: primary

Related Links

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http://www.fsm.it

Related Info

Other Identifiers

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CEC 877

Identifier Type: -

Identifier Source: org_study_id