Effects of Low-frequency Electrical Stimulation in Patients With Advanced HF
Primary Purpose
Heart Failure
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Functional electrical stimulation
Placebo electrical stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure
Eligibility Criteria
Inclusion Criteria:
- Patients with advanced heart failure,
- Class Functional IV, according to the criteria of New York Heart Association (NYHA),
- Aged over 18 years,
- Etiology hypertensive, ischemic, idiopathic or chagas disease,
- Left ventricular ejection fraction ≤ 30%.
Exclusion Criteria:
- Patients with hypertension lung disease and oxygen-dependent,
- Neurological and neuromuscular disease that presenting paresthesia or plegia of the lower limbs,
- Insulin-dependent diabetes mellitus (type I),
- Peripheral arterial occlusive disease,
- Peripheral neuropathy,
- Use of pacemaker or implantable cardiodefibrillator.
Sites / Locations
- Instituto do Coração - HC/FMUSP
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Functional Electrical Stimulation
Control Electrical Stimulation
Arm Description
Functional Electrical Stimulation for 10 days
Control Electrical Stimulation for 10 days
Outcomes
Primary Outcome Measures
Functional assessment
To assess the effects of the functional electrical stimulation in patients with advanced heart failure.
Secondary Outcome Measures
Peripheral function
To assess the effects of the functional electrical stimulation in patients with advanced heart failure.
Peripheral muscle strength
To assess the effects of the functional electrical stimulation in patients with advanced heart failure.
Full Information
NCT ID
NCT01886430
First Posted
April 9, 2013
Last Updated
December 2, 2015
Sponsor
University of Sao Paulo General Hospital
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
1. Study Identification
Unique Protocol Identification Number
NCT01886430
Brief Title
Effects of Low-frequency Electrical Stimulation in Patients With Advanced HF
Official Title
Effects of Low-frequency Electrical Stimulation in Sympathetic Nerve Activity and Peripheral Vasoconstriction in Patients With Advanced HF
Study Type
Interventional
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo General Hospital
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to verify the effects of low frequency functional electrical stimulation in heart failure patients hospitalized for treatment of the syndrome.
Detailed Description
The aim of this study is to assess the effects of low frequency functional electrical stimulation on control autonomic and peripheral function in heart failure patients hospitalized for treatment of the syndrome. A randomized clinical trial with 30 advanced heart failure patients will be randomly assigned to functional electrical stimulation (Functional EE, n= 15) e 2) sensory electrical stimulation (Sensory EE, n=15). The functional electrical stimulation will be applied in the rectus femoris, and gastrocnemius, with frequency of 10 Hz, pulse duration of 150 ms, stimulation time (time on) of 20 seconds, resting time (time off) of 20 seconds and intensity according to the discomfort threshold of the patient , checked every day until achieve a maximum of 70mA. The session will last 60 minuts. It will be held every weekday for a period of 10 days. The effects of interventions on functional capacity, autonomic control, peripheral function, peripheral muscle strength and quality of life will be analyzed at baseline and at the end of the protocol.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Functional Electrical Stimulation
Arm Type
Experimental
Arm Description
Functional Electrical Stimulation for 10 days
Arm Title
Control Electrical Stimulation
Arm Type
Placebo Comparator
Arm Description
Control Electrical Stimulation for 10 days
Intervention Type
Other
Intervention Name(s)
Functional electrical stimulation
Intervention Description
Functional electrical stimulation for 10 days
Intervention Type
Other
Intervention Name(s)
Placebo electrical stimulation
Intervention Description
Placebo electrical stimulation for 10 days
Primary Outcome Measure Information:
Title
Functional assessment
Description
To assess the effects of the functional electrical stimulation in patients with advanced heart failure.
Time Frame
10 days
Secondary Outcome Measure Information:
Title
Peripheral function
Description
To assess the effects of the functional electrical stimulation in patients with advanced heart failure.
Time Frame
10 days
Title
Peripheral muscle strength
Description
To assess the effects of the functional electrical stimulation in patients with advanced heart failure.
Time Frame
10 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with advanced heart failure,
Class Functional IV, according to the criteria of New York Heart Association (NYHA),
Aged over 18 years,
Etiology hypertensive, ischemic, idiopathic or chagas disease,
Left ventricular ejection fraction ≤ 30%.
Exclusion Criteria:
Patients with hypertension lung disease and oxygen-dependent,
Neurological and neuromuscular disease that presenting paresthesia or plegia of the lower limbs,
Insulin-dependent diabetes mellitus (type I),
Peripheral arterial occlusive disease,
Peripheral neuropathy,
Use of pacemaker or implantable cardiodefibrillator.
Facility Information:
Facility Name
Instituto do Coração - HC/FMUSP
City
Sao Paulo
ZIP/Postal Code
05403-900
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
Effects of Low-frequency Electrical Stimulation in Patients With Advanced HF
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