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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02668419
Enrollment
49
Registered
2016-01-29
Start date
2010-01-31
Completion date
2014-12-31
Last updated
2016-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure, Ventricular Dysfunction, Left

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.

Interventions

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.

OTHERPhysical 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.

Sponsors

Federal University of São Paulo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Functional capacity evaluated using the 6-minute walk test (6MWT)Change from assessment at admission and at patient dischargeFunctional 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

MeasureTime frameDescription
Change in the intravenous inotropic support dosageChange from the first day of the protocol and patient dischargeFor 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).

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026