Clinical trial NCT02088138: Functional Electrical Stimulation in Cardiac Patients
Official title: Effects of Functional Electrical Stimulation on Physical Performance of Patients in Cardiac Rehabilitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Disease
Heart Failure
Keywords: Thoracic Surgery
Electrical Stimulation
Rehabilitation
Quality of Life
Lead sponsor: Universidade Federal de Santa Maria
Sponsor class: OTHER
First posted: 2014-03-14
Enrollment: 20
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: Distance on the six minute walk test
timeFrame: Two Years
Secondary outcomes:
measure: Lower limb muscle strength measured by the load (kg) sustained in one repetition maximum test
timeFrame: Two years
measure: Quality of life through The Medical Study 36-Item Short-Form Health Survey (SF-36) questionnaire
timeFrame: Two years
measure: Lower limb muscle tropism evaluated by measuring the thigh circumference by tape
timeFrame: Two years
measure: Lower limb muscle endurance assessed by sit-and-stand test
timeFrame: Two years
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Federal University of Rio Grande do Sul
state: Rio Grande do Sul
city: Porto Alegre
country: Brazil
facility: Federal University of Health Sciences of Porto Alegre
state: Rio Grande do Sul
city: Santa Maria
country: Brazil
facility: Federal University of Santa Maria
state: Rio Grande do Sul
Study officials:
affiliation: Universidade Federal de Santa Maria
name: Antônio M Vargas da Silva, PhD
role: PRINCIPAL_INVESTIGATOR
References: