NCT02088138

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2010

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

February 26, 2014

Completed
16 days until next milestone

First Posted

Study publicly available on registry

March 14, 2014

Completed
Last Updated

March 14, 2014

Status Verified

March 1, 2014

Enrollment Period

9 months

First QC Date

February 26, 2014

Last Update Submit

March 12, 2014

Conditions

Coronary DiseaseHeart Failure

Keywords

Thoracic SurgeryElectrical StimulationRehabilitationQuality of Life

Outcome Measures

Primary Outcomes (1)

  • Distance on the six minute walk test

    Two Years

Secondary Outcomes (4)

  • 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

Study Arms (2)

Functional Electrical Stimulation

EXPERIMENTAL

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

FES placebo

EXPERIMENTAL

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

Interventions

Functional Electrical StimulationDEVICE

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

Also known as: FES
Functional Electrical Stimulation
Functional Electrical Stimulation placeboDEVICE

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

Also known as: FES placebo
FES placebo

Eligibility Criteria

Age21 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients in phase II and III of cardiac rehabilitation undergoing coronary artery bypass grafting or valve replacement

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Federal University of Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, 90040-060, Brazil

Location

Federal University of Health Sciences of Porto Alegre

Porto Alegre, Rio Grande do Sul, 90050-170, Brazil

Location

Federal University of Santa Maria

Santa Maria, Rio Grande do Sul, 97105-900, Brazil

Location

MeSH Terms

Conditions

Coronary DiseaseHeart Failure

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Antônio M Vargas da Silva, PhD

    Universidade Federal de Santa Maria

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PhD in Physiology

Study Record Dates

First Submitted

February 26, 2014

First Posted

March 14, 2014

Study Start

September 1, 2010

Primary Completion

June 1, 2011

Study Completion

June 1, 2012

Last Updated

March 14, 2014

Record last verified: 2014-03

Locations

BR(3)