search
Back to results

Functional Electrical Stimulation in Cardiac Patients

Primary Purpose

Coronary Disease, Heart Failure

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Functional Electrical Stimulation
Functional Electrical Stimulation placebo
Sponsored by
Prof. Dr. Antônio Marcos Vargas da Silva
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Disease focused on measuring Thoracic Surgery, Electrical Stimulation, Rehabilitation, Quality of Life

Eligibility Criteria

21 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Federal University of Rio Grande do Sul
  • Federal University of Health Sciences of Porto Alegre
  • Federal University of Santa Maria

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Functional Electrical Stimulation

FES placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Distance on the six minute walk test

Secondary Outcome Measures

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

Full Information

First Posted
February 26, 2014
Last Updated
March 12, 2014
Sponsor
Prof. Dr. Antônio Marcos Vargas da Silva
search

1. Study Identification

Unique Protocol Identification Number
NCT02088138
Brief Title
Functional Electrical Stimulation in Cardiac Patients
Official Title
Effects of Functional Electrical Stimulation on Physical Performance of Patients in Cardiac Rehabilitation
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Prof. Dr. Antônio Marcos Vargas da Silva

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Disease, Heart Failure
Keywords
Thoracic Surgery, Electrical Stimulation, Rehabilitation, Quality of Life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Functional Electrical Stimulation
Arm Type
Experimental
Arm Description
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.
Arm Title
FES placebo
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Functional Electrical Stimulation
Other Intervention Name(s)
FES
Intervention Description
Functional electrical stimulation twice per week for eight weeks totaling sixteen sessions.
Intervention Type
Device
Intervention Name(s)
Functional Electrical Stimulation placebo
Other Intervention Name(s)
FES placebo
Intervention Description
Functional electrical stimulation in the sensory threshold level, twice a week for eight weeks, totaling sixteen sessions.
Primary Outcome Measure Information:
Title
Distance on the six minute walk test
Time Frame
Two Years
Secondary Outcome Measure Information:
Title
Lower limb muscle strength measured by the load (kg) sustained in one repetition maximum test
Time Frame
Two years
Title
Quality of life through The Medical Study 36-Item Short-Form Health Survey (SF-36) questionnaire
Time Frame
Two years
Title
Lower limb muscle tropism evaluated by measuring the thigh circumference by tape
Time Frame
Two years
Title
Lower limb muscle endurance assessed by sit-and-stand test
Time Frame
Two years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antônio M Vargas da Silva, PhD
Organizational Affiliation
Universidade Federal de Santa Maria
Official's Role
Principal Investigator
Facility Information:
Facility Name
Federal University of Rio Grande do Sul
City
Porto Alegre
State/Province
Rio Grande do Sul
ZIP/Postal Code
90040-060
Country
Brazil
Facility Name
Federal University of Health Sciences of Porto Alegre
City
Porto Alegre
State/Province
Rio Grande do Sul
ZIP/Postal Code
90050-170
Country
Brazil
Facility Name
Federal University of Santa Maria
City
Santa Maria
State/Province
Rio Grande do Sul
ZIP/Postal Code
97105-900
Country
Brazil

12. IPD Sharing Statement

Learn more about this trial

Functional Electrical Stimulation in Cardiac Patients

We'll reach out to this number within 24 hrs