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Completed

NCT Number: NCT02668419

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

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Federal University of Sao Paulo

São Paulo, 04024-002, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Neuromuscular Electrical Stimulator

Device

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)

Physical Therapy Session

Other

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.

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Federal University of São Paulo

Other

Registry information

Official study title

Neuromuscular Electrical Stimulation Improves Exercise Tolerance in Patients With Advanced Heart Failure on Continuous Dobutamine Use - A Randomized Controlled Trial

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Jan 29, 2016
Registry last updated
Jan 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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