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

NCT ID: NCT02668419

Last Updated: 2016-01-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2014-12-31

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.

Conditions

Heart Failure; Ventricular Dysfunction, Left

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Physical Therapy Session

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

Neuromuscular Electrical Stimulator

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: OTHER

Other Intervention Names

NMES; Functional Electrical Stimulation (FES)

Eligibility 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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federal University of São Paulo

OTHER

Sponsor Role: lead

Responsible Party

Patricia Forstieri

PT

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Patricia Forestieri, PT

Role: PRINCIPAL_INVESTIGATOR

Federal University of São Paulo

Locations

Federal University of Sao Paulo

São Paulo, São Paulo, Brazil

Countries

Brazil

Other Identifiers

13132413.0.0000.5505

Identifier Type: -

Identifier Source: org_study_id