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

Primary Purpose

Heart Failure, Ventricular Dysfunction, Left

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Neuromuscular Electrical Stimulator
Physical Therapy Session
Sponsored by
Federal University of São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Federal University of Sao Paulo

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Usual Care

Neuromuscular Electrical Stimulator

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).

Full Information

First Posted
January 19, 2016
Last Updated
January 28, 2016
Sponsor
Federal University of São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT02668419
Brief Title
Electrical Stimulation Improves Exercise Tolerance in Patients With Advanced Heart Failure on Continuous Dobutamine Use
Official Title
Neuromuscular Electrical Stimulation Improves Exercise Tolerance in Patients With Advanced Heart Failure on Continuous Dobutamine Use - A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of São Paulo

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Ventricular Dysfunction, Left

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual Care
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Neuromuscular Electrical Stimulator
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Neuromuscular Electrical Stimulator
Other Intervention Name(s)
NMES, Functional Electrical Stimulation (FES)
Intervention Description
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
Other
Intervention Name(s)
Physical Therapy Session
Intervention Description
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.
Primary Outcome Measure Information:
Title
Functional capacity evaluated using the 6-minute walk test (6MWT)
Description
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.
Time Frame
Change from assessment at admission and at patient discharge
Secondary Outcome Measure Information:
Title
Change in the intravenous inotropic support dosage
Description
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).
Time Frame
Change from the first day of the protocol and patient discharge

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patricia Forestieri, PT
Organizational Affiliation
Federal University of Sao Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Federal University of Sao Paulo
City
Sao Paulo
ZIP/Postal Code
04024-002
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No subject data will be made public. However, all participants were given the principal investigator's e-mail address and phone number in order to ask questions or receive their assessment results.

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

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