Effects of Neuromuscular Electrical Stimulation in Patients With Congestive Heart Failure
NCT ID: NCT02313714
Last Updated: 2014-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
15 participants
INTERVENTIONAL
2012-09-30
2015-12-31
Brief Summary
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All patients in the treatment arm will receive electric muscular stimulation with a Russian current protocol twice a week for 7 weeks.
The outcome will be assessed by the improvement in quality of life and functional capacity.
Detailed Description
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Inclusion criteria:
Age between 30 to 80 years old Congestive heart failure in NYHA class III or IV Ejection fraction lower than 35% Stable clinical status Full pharmacologic treatment
Exclusion criteria:
Unstable angina Ventricular arrhythmia intermittent lameness Inferior limb amputation
Protocol Design:
Patients at waiting list for heart transplant will be invited to participate on protocol of NMES using Russian stimulation wave (2.5 kHz, burst at 50Hz, on/off: 3/9 sec), named NMES group or sham stimulation, named control group. The NMES will be applied for 50 minutes, twice a week on both quadriceps femoral muscles during 7 weeks. The patients will be evaluated every week for distance walked during six minutes walk test (6MWT), heart rate variability, and functional status according to New York Heart Association. All patients were evaluated at the beginning and after completion of the protocol for quality of life with Minnesota Living with Heart Failure Questionnaire (LHFQ).
Conditions
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Keywords
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
SINGLE
Study Groups
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Neuromuscular stimulation
The patients will receive electric muscular stimulation with a Russian current protocol twice a week for 7 weeks.
stimulation wave (2.5 kHz, burst at 50Hz, on/off: 3/9 sec),
All patients in the treatment arm will receive electric muscular stimulation with a Russian current protocol twice a week for 7 weeks.
Sham Group
The patients will receive very low electric muscular stimulation with a no biological or clinical effects
Sham
very low electric muscular stimulation
Interventions
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stimulation wave (2.5 kHz, burst at 50Hz, on/off: 3/9 sec),
All patients in the treatment arm will receive electric muscular stimulation with a Russian current protocol twice a week for 7 weeks.
Sham
very low electric muscular stimulation
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
90 Years
ALL
No
Sponsors
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University of Campinas, Brazil
OTHER
Responsible Party
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Orlando Petrucci
MD, PhD
Principal Investigators
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Maria Carolina Sacilotto, MsC
Role: PRINCIPAL_INVESTIGATOR
University of Campinas
Locations
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University of Campinas
Campinas, São Paulo, Brazil
Countries
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Central Contacts
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Facility Contacts
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Maria Carolina Sacilotto, MsC
Role: primary
Other Identifiers
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ENESPHF
Identifier Type: -
Identifier Source: org_study_id