Functional Electrical Stimulation in Cardiac Patients

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Coronary Disease, Heart Failure

Intervention / Treatment
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* Device: Functional Electrical Stimulation
* Device: Functional Electrical Stimulation placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Functional Electrical Stimulation<br>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. | Device: Functional Electrical Stimulation<br>* Functional electrical stimulation twice per week for eight weeks totaling sixteen sessions.<br>* Other names: FES;|
| Experimental: FES placebo<br>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. | Device: Functional Electrical Stimulation placebo<br>* Functional electrical stimulation in the sensory threshold level, twice a week for eight weeks, totaling sixteen sessions.<br>* Other names: FES placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distance on the six minute walk test |  | Two Years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Thoracic Surgery, Electrical Stimulation, Rehabilitation, Quality of Life