Functional Electrical Stimulation in Cardiac Patients

N/ACompletedNCT02088138

Prof. Dr. Antônio Marcos Vargas da Silva20 enrolled

Overview

The purpose of this study was to determine the effects of Functional Electrical Stimulation (FES) on physical performance and quality of life of patients in cardiac rehabilitation.

This randomized controlled trial aimed to evaluate the effects of functional electrical stimulation (FES) in patients with stage II and III cardiac rehabilitation (CR) on the variables strength, endurance and muscle tropism lower limb, functional capacity and quality of life. To this were invited to participate in the study cardiac patients registered in the database of the cardiology department of the University Hospital of Santa Maria. The sample included patients of both sexes undergoing coronary artery bypass grafting or valve replacement. The subjects were divided into two groups: placebo group (PG) or functional electrical stimulation group (FESG). To verify the effect of this intervention, before and after the protocol patients underwent the following evaluations: one repetition maximum test, sit-and-stand test, perimetry thighs, the six-minute walk test and evaluate the quality of life through The Medical questionnaire Study 36-item Short-Form Health Survey (SF-36).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Coronary Disease Heart Failure

Interventions

Functional Electrical StimulationDEVICE

Functional electrical stimulation twice per week for eight weeks totaling sixteen sessions.

Functional Electrical Stimulation placeboDEVICE

Functional electrical stimulation in the sensory threshold level, twice a week for eight weeks, totaling sixteen sessions.

Eligibility

Sex: ALLMin age: 21 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients in phase II and III of cardiac rehabilitation undergoing coronary artery bypass grafting or valve replacement Exclusion Criteria: * Patients with some cognitive impairment that prevents the completion of assessments, inability to understand the term of free and informed consent or with the following contraindications to the use of FES: epidermal lesions at the site of application, change of skin sensitivity or intolerance electrical stimulator; * Patients undergoing cardiac surgery other than coronary artery bypass grafting or valve replacement; * Patients who use pacemakers; * Subjects with peripheral vascular changes in the lower limbs; * Presence of comorbidities such as chronic obstructive pulmonary disease (COPD), cerebrovascular disease or skeletal muscle disease.

Locations (3)

Federal University of Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, Brazil

Federal University of Health Sciences of Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Federal University of Santa Maria

Santa Maria, Rio Grande do Sul, Brazil

Outcomes

Primary Outcomes

Distance on the six minute walk test

Time frame: Two Years

Secondary Outcomes

Lower limb muscle strength measured by the load (kg) sustained in one repetition maximum test

Time frame: Two years

Quality of life through The Medical Study 36-Item Short-Form Health Survey (SF-36) questionnaire

Time frame: Two years

Lower limb muscle tropism evaluated by measuring the thigh circumference by tape

Time frame: Two years

Lower limb muscle endurance assessed by sit-and-stand test

Time frame: Two years

Data from ClinicalTrials.gov

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