Functional Electrical Stimulation in Cardiac Patients

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02088138

Enrollment

Registered

2014-03-14

Start date

2010-09-30

Completion date

2012-06-30

Last updated

2014-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Disease, Heart Failure

Keywords

Thoracic Surgery, Electrical Stimulation, Rehabilitation, Quality of Life

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).

Interventions

DEVICEFunctional Electrical Stimulation

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

DEVICEFunctional Electrical Stimulation placebo

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

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

21 Years to 80 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Distance on the six minute walk test	Two Years

Secondary

Measure	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

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026