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Electrical Stimulation Improves Exercise Tolerance in Patients With Advanced Heart Failure on Continuous Dobutamine Use

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02668419
Recruitment Status : Completed
First Posted : January 29, 2016
Last Update Posted : January 29, 2016
Sponsor:
Information provided by (Responsible Party):
Patricia Forstieri, Federal University of São Paulo

Brief Summary:
The purpose of this study is to determine whether neuromuscular electrical stimulation can improve exercise tolerance for patients with heart failure and continuous dobutamine use in a hospital.

Condition or disease Intervention/treatment Phase
Heart Failure Ventricular Dysfunction, Left Device: Neuromuscular Electrical Stimulator Other: Physical Therapy Session Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Neuromuscular Electrical Stimulation Improves Exercise Tolerance in Patients With Advanced Heart Failure on Continuous Dobutamine Use - A Randomized Controlled Trial
Study Start Date : January 2010
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Usual Care
Patients in this group were subject to regular Physical Therapy Sessions in the hospital and each session consisted of breathing exercises and global active exercises of the upper and lower limbs in bed. The treatment was applied twice a day during the hospitalization period. The protocol was interrupted if the patient had signs or symptoms suggestive of poor tolerance to exercise.
Other: Physical Therapy Session
each session consisted of breathing exercises and global active exercises of the upper and lower limbs in bed. The treatment was applied twice a day during the hospitalization period. The protocol was interrupted if the patient had signs or symptoms suggestive of poor tolerance to exercise: 1) cyanosis, pallor, dizziness, nausea or pre-syncope; 2) chest pain; 3) bradycardia; 4) a drop in systolic blood pressure >15 mmHg in comparison to baseline; 5) an excessive rise in systolic blood pressure defined as >200 mmHg; 6) a rise in diastolic blood pressure during exercise >110 mmHg; 7) fatigue rated ≥6/10 on the perceived exertion Borg scale (PEB); and/or 8) electrocardiographic signs of cardiac ischemia or ventricular arrhythmias.

Experimental: Neuromuscular Electrical Stimulator
Lower limb muscles of both legs were simultaneously stimulated using self adhesive surface rectangular electrodes. During all session period, the patients were maintained in the supine Fowler 45º position. The stimulation intensity was progressively increased according to the patient tolerance until a muscular contraction was observed. Stimulation was performed twice a day; the session duration was 60 min. Heart rate, blood pressure, respiratory rate and pulse oximetry were monitored throughout the sessions, in all patients.
Device: Neuromuscular Electrical Stimulator
Quadriceps and calf muscles of both legs were simultaneously stimulated using self adhesive surface rectangular electrodes. During all session period, the patients were maintained in the supine Fowler 45º position. Stimulation parameters were set up as follows: biphasic current of 40 Hz, 400-µs pulse duration, mode "on-time" 10s and "off-time" 20s and maximal amplitude of 60 mA. The stimulation intensity was progressively increased according to the patient tolerance until a muscular contraction was observed. Stimulation was performed twice a day; the session duration was 60 min.
Other Names:
  • NMES
  • Functional Electrical Stimulation (FES)




Primary Outcome Measures :
  1. Functional capacity evaluated using the 6-minute walk test (6MWT) [ Time Frame: Change from assessment at admission and at patient discharge ]
    Functional capacity was evaluated using the 6-minute walk test (6MWT), by a single evaluator blinded to the group allotment, in accordance with American Thoracic Society criteria.


Secondary Outcome Measures :
  1. Change in the intravenous inotropic support dosage [ Time Frame: Change from the first day of the protocol and patient discharge ]
    For all patients, the inotropic intravenous dose was adjusted daily by a single clinician (prescriber) blinded to the group allocation. Weaning from inotropic support was performed by the prescriber based on the improvement of clinical signs (level of consciousness, peripheral perfusion and blood pressure).



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Advanced heart failure (Stage D - Left ventricle ejection fraction <30%)
  • New York Heart Association class III-IV
  • Standard medical therapy for heart failure management
  • Continuous inotropic infusion

Exclusion Criteria:

  • Unstable angina pectoris
  • Recent (6 months) acute coronary syndrome
  • Arrythmias
  • Chronic renal failure
  • Diabetes Mellitus
  • Peripheral vascular diseases
  • Inability to walk

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02668419


Locations
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Brazil
Federal University of Sao Paulo
Sao Paulo, Brazil, 04024-002
Sponsors and Collaborators
Federal University of São Paulo
Investigators
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Principal Investigator: Patricia Forestieri, PT Federal University of Sao Paulo

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Responsible Party: Patricia Forstieri, PT, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT02668419    
Other Study ID Numbers: 13132413.0.0000.5505
First Posted: January 29, 2016    Key Record Dates
Last Update Posted: January 29, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No subject data will be made public. However, all participants were given the principal investigator's e-mail address and phone number in order to ask questions or receive their assessment results.
Additional relevant MeSH terms:
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Heart Failure
Ventricular Dysfunction
Ventricular Dysfunction, Left
Heart Diseases
Cardiovascular Diseases
Dobutamine
Cardiotonic Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents