Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Functional Electrical Stimulation in Cardiac Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02088138
Recruitment Status : Completed
First Posted : March 14, 2014
Last Update Posted : March 14, 2014
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. Antônio Marcos Vargas da Silva, Universidade Federal de Santa Maria

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.

Condition or disease Intervention/treatment Phase
Coronary Disease Heart Failure Device: Functional Electrical Stimulation Device: Functional Electrical Stimulation placebo Not Applicable

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).

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Functional Electrical Stimulation on Physical Performance of Patients in Cardiac Rehabilitation
Study Start Date : September 2010
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Functional Electrical Stimulation

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
Functional electrical stimulation twice per week for eight weeks totaling sixteen sessions.
Other Name: FES

Experimental: FES placebo

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
Functional electrical stimulation in the sensory threshold level, twice a week for eight weeks, totaling sixteen sessions.
Other Name: FES placebo




Primary Outcome Measures :
  1. Distance on the six minute walk test [ Time Frame: Two Years ]

Secondary Outcome Measures :
  1. Lower limb muscle strength measured by the load (kg) sustained in one repetition maximum test [ Time Frame: Two years ]
  2. Quality of life through The Medical Study 36-Item Short-Form Health Survey (SF-36) questionnaire [ Time Frame: Two years ]
  3. Lower limb muscle tropism evaluated by measuring the thigh circumference by tape [ Time Frame: Two years ]
  4. Lower limb muscle endurance assessed by sit-and-stand test [ Time Frame: Two years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02088138


Locations
Layout table for location information
Brazil
Federal University of Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, Brazil, 90040-060
Federal University of Health Sciences of Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil, 90050-170
Federal University of Santa Maria
Santa Maria, Rio Grande do Sul, Brazil, 97105-900
Sponsors and Collaborators
Prof. Dr. Antônio Marcos Vargas da Silva
Investigators
Layout table for investigator information
Principal Investigator: Antônio M Vargas da Silva, PhD Universidade Federal de Santa Maria
Layout table for additonal information
Responsible Party: Prof. Dr. Antônio Marcos Vargas da Silva, PhD in Physiology, Universidade Federal de Santa Maria
ClinicalTrials.gov Identifier: NCT02088138    
Other Study ID Numbers: FESCP01
First Posted: March 14, 2014    Key Record Dates
Last Update Posted: March 14, 2014
Last Verified: March 2014
Keywords provided by Prof. Dr. Antônio Marcos Vargas da Silva, Universidade Federal de Santa Maria:
Thoracic Surgery
Electrical Stimulation
Rehabilitation
Quality of Life
Additional relevant MeSH terms:
Layout table for MeSH terms
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Myocardial Ischemia
Vascular Diseases