Functional Electrical Stimulation in Cardiac Patients

NCT ID: NCT02088138

Last Updated: 2014-03-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2012-06-30

Brief Summary

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.

Detailed Description

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).

Conditions

Coronary Disease; Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Functional Electrical Stimulation

Functional Electrical Stimulation

In the intervention group the FES was applied in the medial and lateral vastus of both thighs targeting the movement of knee extension. The application frequency was 15 Hz, lasting 40 minutes, pulse width of 0.5 ms, time ON 5s, time OFF 10s, ramp-up of 0 or 1s, descent ramp 2s and intensity as tolerance patient.

Group Type: EXPERIMENTAL

Functional Electrical Stimulation

Intervention Type: DEVICE

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

FES placebo

Functional Electrical Stimulation placebo

The placebo group received functional electrical stimulation with the same parameters in the intervention group, except that the intensity of stimulation did not lead to visible or palpable contraction.

Group Type: EXPERIMENTAL

Functional Electrical Stimulation placebo

Intervention Type: DEVICE

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

Interventions

Functional Electrical Stimulation

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

Intervention Type: DEVICE

Functional Electrical Stimulation placebo

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

Intervention Type: DEVICE

Other Intervention Names

FES; FES placebo

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Prof. Dr. Antônio Marcos Vargas da Silva

OTHER

Sponsor Role: lead

Responsible Party

Prof. Dr. Antônio Marcos Vargas da Silva

PhD in Physiology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Antônio M Vargas da Silva, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidade Federal de Santa Maria

Locations

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

Countries

Brazil

Other Identifiers

FESCP01

Identifier Type: -

Identifier Source: org_study_id