Early-start Exercise Training in Subacute Heart Failure

NCT02051985 | Unknown DMC

• 1 other identifier: CEC 877
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 9

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.

Conditions

Chronic Heart Failure; Heart Decompensation

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Distance walked at 6-min walking test

  Change from baseline in distance walked at 6-min walking test

  12 days of intervention

Secondary Outcomes (4)

• Aerobic exercise training safety and tolerability

  12 days of treatment

• Patient-reported dyspnea, evaluated by a 7-point Likert scale

  12 days of intervention

• Levels of lymphocyte G protein-coupled receptor kinase-2

  12 days of intervention

• Levels of circulating inflammatory and angiogenetic markers (TNF-alfa, Interleukin-6, Angiopoietin 2 and VEGF)

  12 days of intervention

Study Arms (2)

Aerobic exercise training

EXPERIMENTAL

Other: Aerobic exercise training

Standard physical therapy

ACTIVE COMPARATOR

Other: Standard physical therapy

Interventions

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.

Aerobic exercise training

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.

Standard physical therapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione Salvatore Maugeri: lead

Study Sites (9)

Fondazione Salvatore Maugeri, IRCCS - Scientific Institute of Cassano Murge

Cassano Murge, 70020, Italy

RECRUITING

Fondazione Salvatore Maugeri, IRCCS - Scientific Institute of Lumezzane

Lumezzane, 25066, Italy

RECRUITING

Fondazione Salvatore Maugeri - Scientific Institute of Milano

Milan, 20138, Italy

RECRUITING

Fondazione Salvatore Maugeri, IRCCS - Scientific Institute of Montescano

Montescano, 27040, Italy

RECRUITING

Fondazione Salvatore Maugeri, IRCCS - Scientific Institute of Pavia

Pavia, 27100, Italy

RECRUITING

Fondazione Salvatore Maugeri, IRCCS - Scientific Institute of Telese Terme

Telese Terme, 82037, Italy

RECRUITING

Fondazione Salvatore Maugeri - Presidio Major of Torino

Torino, 10124, Italy

RECRUITING

Fondazione Salvatore Maugeri, IRCCS - Scientific Institute of Tradate

Tradate, 21049, Italy

RECRUITING

Fondazione Salvatore Maugeri, IRCCS - Scientific Institute of Veruno

Veruno, 28010, Italy

RECRUITING

Related Links

• Related Info

MeSH Terms

Conditions

Heart Failure; Dyspnea

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Pantaleo Giannuzzi, MD

  Fondazione Salvatore Maugeri - Scientific Institute of Veruno

  STUDY CHAIR

• Alessandro Mezzani, MD

  Fondazione Salvatore Maugeri - Scientific Institute of Veruno

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alessandro Mezzani, MD

CONTACT

+39-3403119299; alessandro.mezzani@fsm.it

Pantaleo Giannuzzi, MD

CONTACT

+39-0322-884812; pantaleo.giannuzzi@fsm.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 29, 2014
• First Posted: January 31, 2014
• Study Start: October 1, 2013
• Primary Completion: June 1, 2015
• Study Completion: September 1, 2015
• Last Updated: January 31, 2014

Record last verified: 2014-01

Locations

IT (9)