Effects of Neuromuscular Electrical Stimulation in Patients With Congestive Heart Failure
Primary Purpose
Heart Failure
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
stimulation wave (2.5 kHz, burst at 50Hz, on/off: 3/9 sec),
Sham
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring heart failure, heart transplant, electrical stimulation
Eligibility Criteria
Inclusion Criteria:
- patients on waiting list for heart transplant
Exclusion Criteria:
- patients that won't accept to participate in the protocol
Sites / Locations
- University of CampinasRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Neuromuscular stimulation
Sham Group
Arm Description
The patients will receive electric muscular stimulation with a Russian current protocol twice a week for 7 weeks.
The patients will receive very low electric muscular stimulation with a no biological or clinical effects
Outcomes
Primary Outcome Measures
Improvement on distance walked in the six minute walk test
Secondary Outcome Measures
Improvement on quality of life
Full Information
NCT ID
NCT02313714
First Posted
November 27, 2013
Last Updated
December 9, 2014
Sponsor
University of Campinas, Brazil
1. Study Identification
Unique Protocol Identification Number
NCT02313714
Brief Title
Effects of Neuromuscular Electrical Stimulation in Patients With Congestive Heart Failure
Official Title
Effects of Neuromuscular Electrical Stimulation in Patients With Congestive Heart Failure
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Unknown status
Study Start Date
September 2012 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Campinas, Brazil
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study intends to treat patient with congestive heart failure that are maximized their pharmacological treatment and at heart transplant wait list.
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
The neuromuscular electrical stimulation (NMES) has been used as adjuvant treatment in patients with end-stage congestive heart failure. Those patients are limited to perform conventional physical activity and adherence to any every day protocols frequency. The aim of this study was evaluated the effect on functional status and quality of life after NMES treatment using Russian stimulation wave solely twice a week during five weeks period in patients waiting for a heart transplant.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
heart failure, heart transplant, electrical stimulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Neuromuscular stimulation
Arm Type
Experimental
Arm Description
The patients will receive electric muscular stimulation with a Russian current protocol twice a week for 7 weeks.
Arm Title
Sham Group
Arm Type
Placebo Comparator
Arm Description
The patients will receive very low electric muscular stimulation with a no biological or clinical effects
Intervention Type
Device
Intervention Name(s)
stimulation wave (2.5 kHz, burst at 50Hz, on/off: 3/9 sec),
Other Intervention Name(s)
Neuromuscular stimulation
Intervention Description
All patients in the treatment arm will receive electric muscular stimulation with a Russian current protocol twice a week for 7 weeks.
Intervention Type
Device
Intervention Name(s)
Sham
Intervention Description
very low electric muscular stimulation
Primary Outcome Measure Information:
Title
Improvement on distance walked in the six minute walk test
Time Frame
after 7 weeks of first inttervention
Secondary Outcome Measure Information:
Title
Improvement on quality of life
Time Frame
7 weeks after first intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients on waiting list for heart transplant
Exclusion Criteria:
patients that won't accept to participate in the protocol
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maria Carolina Sacilotto, MsC
Phone
+55 19 989464664
Email
carolsaci@yahoo.com.br
First Name & Middle Initial & Last Name or Official Title & Degree
Orlando Petrucci, MD, PhD
Phone
+55 19 997253335
Email
orlando@fcm.unicamp.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Carolina Sacilotto, MsC
Organizational Affiliation
University of Campinas
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Campinas
City
Campinas
State/Province
São Paulo
ZIP/Postal Code
13100000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Carolina Sacilotto, MsC
12. IPD Sharing Statement
Learn more about this trial
Effects of Neuromuscular Electrical Stimulation in Patients With Congestive Heart Failure
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