Functional Electrical Stimulation in Cardiac Patients

Heart Failure Clinical Trial

Official title:

Effects of Functional Electrical Stimulation on Physical Performance of Patients in Cardiac Rehabilitation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02088138
• Other study ID #: FESCP01
• Status: Completed
• Phase: N/A
• First received: February 26, 2014
• Last updated: March 12, 2014
• Start date: September 2010
• Est. completion date: June 2012

Study information

• Verified date: March 2014
• Source: Universidade Federal de Santa Maria
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 2012
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Heart Failure

Intervention

Device:
• Functional Electrical Stimulation
Functional electrical stimulation twice per week for eight weeks totaling sixteen sessions.
• Functional Electrical Stimulation placebo
Functional electrical stimulation in the sensory threshold level, twice a week for eight weeks, totaling sixteen sessions.

Locations

Country	Name	City	State
Brazil	Federal University of Health Sciences of Porto Alegre	Porto Alegre	Rio Grande do Sul
Brazil	Federal University of Rio Grande do Sul	Porto Alegre	Rio Grande do Sul
Brazil	Federal University of Santa Maria	Santa Maria	Rio Grande do Sul

Sponsors (1)

Lead Sponsor	Collaborator
Prof. Dr. Antônio Marcos Vargas da Silva

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Distance on the six minute walk test		Two Years	No
Secondary	Lower limb muscle strength measured by the load (kg) sustained in one repetition maximum test		Two years	No
Secondary	Quality of life through The Medical Study 36-Item Short-Form Health Survey (SF-36) questionnaire		Two years	No
Secondary	Lower limb muscle tropism evaluated by measuring the thigh circumference by tape		Two years	No
Secondary	Lower limb muscle endurance assessed by sit-and-stand test		Two years	No