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

NCT ID: NCT01777659

Last Updated: 2013-11-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2013-10-31

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).

Detailed 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).

Conditions

Acute Myocardial Infarction

Keywords

exercise; neuromodulation; blood flow; exercise capacity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

TENS CABG

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.

Group Type: EXPERIMENTAL

Transcutaneous electrical nerve stimulation

Intervention Type: DEVICE

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.

P-TENS CABG

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).

Group Type: PLACEBO_COMPARATOR

Transcutaneous electrical nerve stimulation

Intervention Type: DEVICE

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.

Interventions

Transcutaneous electrical nerve stimulation

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.

Intervention Type: DEVICE

Other Intervention Names

TENS; electrical stimulation

Eligibility Criteria

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.

• Minimum Eligible Age: 48 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Brasilia

OTHER

Sponsor Role: collaborator

Hospital Sao Joao

OTHER

Sponsor Role: collaborator

Hospital de Clinicas de Porto Alegre

OTHER

Sponsor Role: lead

Responsible Party

GASPAR ROGERIO DA SILVA CHIAPPA, Principal Investigator

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gaspar R Chiappa, Dr, ScD

Role: PRINCIPAL_INVESTIGATOR

Federal University of Rio Grande do Sul

Locations

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Countries

Brazil

Other Identifiers

12-0317

Identifier Type: -

Identifier Source: org_study_id