Functional Electrical Stimulation in Cardiac Patients

Not Applicable

Completed

• Conditions: Coronary Disease; Heart Failure
• Interventions: Device: Functional Electrical Stimulation; Device: Functional Electrical Stimulation placebo

• Registration Number: NCT02088138
• Lead Sponsor: Prof. Dr. Antônio Marcos Vargas da Silva

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).

Study Timeline

• Study Start: 2010-09
• Primary Completion: 2011-06
• Study Completion: 2012-06
• Study First Submitted: 2014-02-26
• Status Verified: 2014-03
• Study First Submitted QC: 2014-03-12
• Last Update Submitted: 2014-03-12
• Study First Posted: 2014-03-14
• Last Update Posted: 2014-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Functional Electrical Stimulation	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.
FES placebo	Functional Electrical Stimulation 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.

Primary Outcome Measures

Name	Time	Method
Distance on the six minute walk test	Two Years

Secondary Outcome Measures

Name	Time	Method
Lower limb muscle strength measured by the load (kg) sustained in one repetition maximum test	Two years
Quality of life through The Medical Study 36-Item Short-Form Health Survey (SF-36) questionnaire	Two years
Lower limb muscle tropism evaluated by measuring the thigh circumference by tape	Two years
Lower limb muscle endurance assessed by sit-and-stand test	Two years

Trial Locations

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