Clinical trial NCT02313714: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Heart Failure
Keywords: heart failure, heart transplant, electrical stimulation
Lead sponsor: University of Campinas, Brazil
Sponsor class: OTHER
First posted: 2014-12-10
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

Eligibility criteria: Inclusion Criteria:

* patients on waiting list for heart transplant

Exclusion Criteria:

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

Primary outcomes:
measure: Improvement on distance walked in the six minute walk test
timeFrame: after 7 weeks of first inttervention
Secondary outcomes:
measure: Improvement on quality of life
timeFrame: 7 weeks after first intervention
Other outcomes:
Locations:
city: Campinas
country: Brazil
facility: University of Campinas
state: São Paulo
Study officials:
affiliation: University of Campinas
name: Maria Carolina Sacilotto, MsC
role: PRINCIPAL_INVESTIGATOR
References: