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Clinical Trials/NCT02668419
NCT02668419
Completed
N/A

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

Federal University of São Paulo1 site in 1 country49 target enrollmentJanuary 2010

Overview

Phase
N/A
Intervention
Not specified
Conditions
Heart Failure
Sponsor
Federal University of São Paulo
Enrollment
49
Locations
1
Primary Endpoint
Functional capacity evaluated using the 6-minute walk test (6MWT)
Status
Completed
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2010
End Date
December 2014
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Federal University of São Paulo
Responsible Party
Principal Investigator
Principal Investigator

Patricia Forstieri

PT

Federal University of São Paulo

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

Outcomes

Primary Outcomes

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

  • Change in the intravenous inotropic support dosage(Change from the first day of the protocol and patient discharge)

Study Sites (1)

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