Effects of Neuromuscular Electrical Stimulation in Patients With Congestive Heart Failure

University of Campinas, Brazil

Status: Unknown

Conditions: Heart Failure

Treatments: Device: stimulation wave (2.5 kHz, burst at 50Hz, on/off: 3/9 sec),; Device: Sham

Study type: Interventional

Funder types: Other

Identifiers

NCT02313714

ENESPHF

Details and patient eligibility

About

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.

Full 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).

Enrollment: 15 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients on waiting list for heart transplant

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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15 participants in 2 patient groups, including a placebo group

Neuromuscular stimulation

Experimental group

Description:

The patients will receive electric muscular stimulation with a Russian current protocol twice a week for 7 weeks.

Treatment:

Device: stimulation wave (2.5 kHz, burst at 50Hz, on/off: 3/9 sec),

Sham Group

Placebo Comparator group

Description:

The patients will receive very low electric muscular stimulation with a no biological or clinical effects

Treatment:

Device: Sham