Transcutaneous Electrical Nerve Stimulation Improves Vascular Conductance After Coronary Artery Bypass Graft Surgery (TEBCABG)

H

Hospital de Clinicas de Porto Alegre

Status

Completed

Conditions

Acute Myocardial Infarction

Treatments

Device: Transcutaneous electrical nerve stimulation

Study type

Interventional

Funder types

Other

Identifiers

NCT01777659
12-0317

Details and patient eligibility

About

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).

Full description

Thirty-eight patients will be randomized to a (4 times/day; 30 min/session) for 5-day program of TENS (n = 20) or to placebo-TENS (P-TENS, n = 18) applied on cervical region (C7-T4). Acute sympathetic stimulation by cold pressor test (CPT), Maximal voluntary contraction (MVC), Femoral blood flow (FBF) and femoral vascular conductance (FVC) will be measured as primary outcome pre and post-CABG, even as the 6-minute walk test (6-MWT), Inspiratory and expiratory muscle strength (PImax and PEmax) and β-endorphin as a secondary clinical parameters. In addition, amount of opioid analgesic and pain intensity also will be measured throughout at first 24 hours after CABG (immediately, 6, 12 and 24 hours).

Enrollment

38 patients

Sex

All

Ages

48 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

38 participants in 2 patient groups, including a placebo group

TENS CABG
Experimental group
Description:
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.
Treatment:
Device: Transcutaneous electrical nerve stimulation
P-TENS CABG
Placebo Comparator group
Description:
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).
Treatment:
Device: Transcutaneous electrical nerve stimulation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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