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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02668419
• Other study ID #: 13132413.0.0000.5505
• Status: Completed
• Phase: N/A
• First received: January 19, 2016
• Last updated: January 28, 2016
• Start date: January 2010
• Est. completion date: December 2014

Study information

• Verified date: January 2016
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Failure
• Ventricular Dysfunction
• Ventricular Dysfunction, Left

Intervention

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:
• 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.

Locations

Country	Name	City	State
Brazil	Federal University of Sao Paulo	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional capacity evaluated using the 6-minute walk test (6MWT)	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.	Change from assessment at admission and at patient discharge	Yes
Secondary	Change in the intravenous inotropic support dosage	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).	Change from the first day of the protocol and patient discharge	Yes