NCT01777659

Brief Summary

The investigators will test the hypothesis that transcutaneous electrical nerve stimulation (TENS) may attenuate peripheral vasoconstriction and to improve blood flow redistribution during handgrip exercise in acute myocardial infarction (AMI) patients after Coronary Arterial Bypass Graft Surgery (CABG).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

January 23, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 29, 2013

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

November 8, 2013

Status Verified

November 1, 2013

Enrollment Period

7 months

First QC Date

January 23, 2013

Last Update Submit

November 7, 2013

Conditions

Acute Myocardial Infarction

Keywords

exerciseneuromodulationblood flowexercise capacity

Outcome Measures

Primary Outcomes (1)

  • Blood flow redistribution - baseline and 5 days later

    The ultrasound Doppler system will be equipped with two linear array transducers operating at an imaging frequency of 7- 8 megahertz (MHz). The common femoral artery of the left leg will be insonated distal to the inguinal ligament, 2-3 cm proximal to the bifurcation. Using femoral artery diameter and mean blood velocity (MBF), femoral blood flow (FBF) was calculated as MBF π x (vessel diameter/2)2 x 60. Femoral vascular resistance (FVR) and femoral vascular conductance (FVC) were calculated as (MBP/FBF) and (FBF/MBP \* 100 mm Hg), the conductance multiplied by 100 mmHg so that the conductance units will be similar to the units of femoral blood flow (10, 45). The magnitude of reduction FVC (expressed in %) was calculated as vascular conductance during exercise (% change) - conductance at rest (% change) expressed by % of baseline.

    1 day

Secondary Outcomes (1)

  • Inspiratory and Expiratory Muscle Function

    5 day

Other Outcomes (3)

  • Pain Intensity

    5 day

  • Opioid Analgesic Amount

    5 day

  • β-Endorphin Analysis

    5 day

Study Arms (2)

TENS CABG

EXPERIMENTAL

Eligible patients will be randomized to a transcutaneous electrical nerve stimulation program (TENS; n = 20) or to placebo-TENS (P-TENS; n = 18). All patients were followed by their own physicians, received routine nursing assistance, and were visited daily by one of the investigators, but P-TENS group will be not exposed to any specific electrical stimulation or motor physical intervention.

Device: Transcutaneous electrical nerve stimulation

P-TENS CABG

PLACEBO COMPARATOR

Patients will be treated with placebo-TENS (P-TENS) condition for 5 days (4 times/day; 30 min/session) applied on cervical region (C7-T4). P-TENS device underwent modifications in its internal programming: the control capacitor of the time constant was changed and the active time between pulses was modified from 330 milliseconds to 33 seconds, in order to prevent an analgesic effect (33).

Device: Transcutaneous electrical nerve stimulation

Interventions

Transcutaneous electrical nerve stimulationDEVICE

Patients will be treated with conventional TENS (ENDOMED 684 Device, ENRAF-Nonius B.V., Rotterdam, Netherlands) for 5 days (4 times/day; 30 min/session) applied on cervical region (C7-T4). TENS intervention was applied as described elsewhere.

Also known as: TENS, electrical stimulation
P-TENS CABGTENS CABG

Eligibility Criteria

Age48 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • a previous history of more than 1 vessel coronary artery disease,
  • lifelong abstinence from tobacco, and
  • formal indication for CABG, according to established guideline.

You may not qualify if:

  • Patients older than 70 years of age, with chronic renal failure, or with unstable angina in the 48 h prior to CABG, moderate or severe valve disease, complex cardiac arrhythmias, stroke, and/or inability to exercise the lower limbs.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-007, Brazil

Location

MeSH Terms

Conditions

Motor Activity

Interventions

Transcutaneous Electric Nerve StimulationElectric Stimulation

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsPhysical Therapy ModalitiesRehabilitationAnalgesiaAnesthesia and AnalgesiaPhysical StimulationInvestigative Techniques

Study Officials

  • Gaspar R Chiappa, Dr, ScD

    Federal University of Rio Grande do Sul

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

January 23, 2013

First Posted

January 29, 2013

Study Start

March 1, 2013

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

November 8, 2013

Record last verified: 2013-11

Locations

BR(1)