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

Not Applicable

Completed

• Conditions: Heart Failure; Ventricular Dysfunction, Left
• Interventions: Other: Physical Therapy Session; Device: Neuromuscular Electrical Stimulator

• Registration Number: NCT02668419
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2016-01
• Study First Submitted: 2016-01-19
• Study First Submitted QC: 2016-01-28
• Last Update Submitted: 2016-01-28
• Study First Posted: 2016-01-29
• Last Update Posted: 2016-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual Care	Physical Therapy Session	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.
Neuromuscular Electrical Stimulator	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.

Primary Outcome Measures

Name	Time	Method
Functional capacity evaluated using the 6-minute walk test (6MWT)	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

Name	Time	Method
Change in the intravenous inotropic support dosage	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).

Trial Locations

Locations (1)

Federal University of Sao Paulo; 🇧🇷 Sao Paulo, Brazil