Effects of Neuromuscular Electrical Stimulation in Patients With Congestive Heart Failure

Heart Failure Clinical Trial

Official title:

Effects of Neuromuscular Electrical Stimulation in Patients With Congestive Heart Failure

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02313714
• Other study ID #: ENESPHF
• Status: Recruiting
• Phase: N/A
• First received: November 27, 2013
• Last updated: December 9, 2014
• Start date: September 2012
• Est. completion date: December 2015

Study information

• Verified date: December 2014
• Source: University of Campinas, Brazil
• Contact: Maria Carolina Sacilotto, MsC
• Phone: +55 19 989464664
• Email: carolsaci[@]yahoo.com.br
• Is FDA regulated: No
• Health authority: Brazil: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• patients on waiting list for heart transplant

Exclusion Criteria:

• patients that won't accept to participate in the protocol

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Failure

Intervention

Device:
• 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

Locations

Country	Name	City	State
Brazil	University of Campinas	Campinas	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Campinas, Brazil

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement on distance walked in the six minute walk test		after 7 weeks of first inttervention	No
Secondary	Improvement on quality of life		7 weeks after first intervention	No