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Completed

NCT Number: NCT02088138

Functional Electrical Stimulation in Cardiac Patients

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.

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Key information

Age range

21 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Federal University of Health Sciences of Porto Alegre, Porto Alegre, Rio Grande do Sul, Brazil

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

functional electrical stimulation

Device

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

Other names: FES

Functional Electrical Stimulation placebo

Device

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

Other names: FES placebo

Primary outcomes

  1. Distance on the six minute walk test

    Time frame: Two Years

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Prof. Dr. Antônio Marcos Vargas da Silva

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
Mar 14, 2014
Registry last updated
Mar 14, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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