NCT03096158

Brief Summary

Background: Coronary artery bypass grafting (CABG) due to coronary artery disease (CAD) is one of the main surgical procedures performed in the area of cardiology. Individuals undergoing CABG present sarcopenia, decreased muscle strength of the lower limbs, decreased respiratory muscle strength and dyspnea due to immobility in the bed and the inherent conditions of the disease itself. Cardiorespiratory rehabilitation techniques are rarely used with measurement in hospitals and can greatly favor an early and effective reestablishment to this population in several parameters. Objective: To evaluate the effect of functional electrical stimulation (FES), ventilatory muscle training (TREMVEN), early aerobic training (AERO) and isometric handgrip training (ISO) on the functional capacity, endothelial function and cardiac parameters of individuals undergoing CABG. Methods: In a randomized clinical trial, volunteers will be allocated into four groups: EEF, TREMVEN, AERO or ISO in the preoperative period of CABG. After 48 hours (postoperative midway) of the surgery, the protocol will begin until after hospital discharge. The endpoints evaluated will be: functional capacity, respiratory muscle strength, systolic and diastolic function, arterial endothelial function, inflammatory profile and plasma levels of vascular endothelial growth factor (VEGF). Scientific contributions: Phase 1 cardiorespiratory rehabilitation with alternative interventions may provide an increase in functional capacity, strengthening of respiratory muscles, improvement in cardiac and endothelial functions, as well as increased systemic VEGF levels (myocardial revascularization) and improvement of the inflammatory profile, effectively forwarding the individuals to the rehabilitation phase 2.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2017

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

March 16, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 30, 2017

Completed
2 days until next milestone

Study Start

First participant enrolled

April 1, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

August 7, 2019

Status Verified

July 1, 2018

Enrollment Period

1.5 years

First QC Date

March 16, 2017

Last Update Submit

August 5, 2019

Conditions

Coronary Artery Bypass GraftingCoronary Artery DiseaseCardiac Rehabilitation

Keywords

Coronary artery bypass graftingCardiorespiratory rehabilitationFunctional electrical stimulationInspiratory muscle trainingAerobic trainingIsometric handgrip trainingFunctional capacityEndothelial functionCardiac function

Outcome Measures

Primary Outcomes (1)

  • Functional Capacity - Six-Minute Walk Test (6MWT)

    The 6MWT will be performed to assess functional capacity following the guidelines proposed by the American Thoracic Society.

    Pre and post (7 days) coronary artery bypass surgery

Secondary Outcomes (6)

  • Cardiac Function - Echocardiography

    Pre and post (7 days) coronary artery bypass surgery

  • Endothelial Function- Flow-Mediated Dilation (FMD)

    Pre and post (7 days) coronary artery bypass surgery

  • Femoral Quadriceps Perimetry

    Pre and post (7 days) coronary artery bypass surgery

  • Maximal Inspiratory Pressure

    Pre and post (7 days) coronary artery bypass surgery

  • Handgrip Strength

    Pre and post (7 days) coronary artery bypass surgery

  • +1 more secondary outcomes

Study Arms (3)

Ventilatory Muscle Training (TREMVEN)

EXPERIMENTAL

The enrolled participants will perform inspiratory muscle training (IMT) for 20 minutes during the period of hospitalization, using the Power Breathe device (POWERbreathe International LTD). During training, subjects will be instructed to maintain diaphragmatic breathing at a rate at 15 to 20 breaths/min. The inspiratory load will be set at 30% of maximal static inspiratory pressure (PImax). It will be occur once per day until the hospital exit.

Other: Ventilatory Muscle Training (TREMVEN)

Aerobic Training (AERO)

EXPERIMENTAL

It will consist of supervised walking, lasting 20 minutes a day, during the period of hospitalization of the participants. Heart rate (HR) will be constantly monitored through a cardiac monitor (Polar), with the objective of maintaining between 50 and 60% of the maximum HR predicted by age; Similar to 40 to 50% of VO2max. Blood pressure, oxygen saturation (SpO2) and level of dyspnea (Borg's effort perception scale) will also be monitored constantly. It will be occur once per day until the hospital exit.

Other: Aerobic Training (AERO)

Isometric Handgrip Training (ISO)

EXPERIMENTAL

Study participants will perform 5 x 2 min alternating bilateral contractions of the hand flexor muscles at 30% maximum voluntary contraction with one minute rest between contractions, in a total of 20 minutes training during the period of hospitalization. It will be occur once per day until the hospital exit.

Other: Isometric Handgrip Training (ISO)

Interventions

Ventilatory Muscle Training (TREMVEN)OTHER

Early cardiac rehabilitation after coronary artery bypass graft: The enrolled participants will perform IMT or P-IMT for 20 minutes during the period of hospitalization, using the Power Breathe device (POWERbreathe International LTD). During training, subjects will be instructed to maintain diaphragmatic breathing at a rate at 15 to 20 breaths/min. The inspiratory load will be set at 30% of maximal static inspiratory pressure (PImax). It will be occur once per day until the hospital exit.

Ventilatory Muscle Training (TREMVEN)
Aerobic Training (AERO)OTHER

Early cardiac rehabilitation after coronary artery bypass graft: It will consist of supervised walking, lasting 20 minutes a day, during the period of hospitalization of the participants. Heart rate (HR) will be constantly monitored through a cardiac monitor (Polar), with the objective of maintaining between 50 and 60% of the maximum HR predicted by age; Similar to 40 to 50% of VO2max. Blood pressure, SpO2 and level of dyspnea (Borg's effort perception scale) will also be monitored constantly. It will be occur once per day until the hospital exit.

Aerobic Training (AERO)
Isometric Handgrip Training (ISO)OTHER

Early cardiac rehabilitation after coronary artery bypass graft: Study participants will perform 5 x 2 min alternating bilateral contractions of the hand flexor muscles at 30% maximum voluntary contraction with one minute rest between contractions, in a total of 20 minutes training during the period of hospitalization. It will be occur once per day until the hospital exit.

Isometric Handgrip Training (ISO)

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Be elective for the first CABG due to a previous ischemic event;
  • Do not present other associated heart diseases;
  • Absence of history of neuromuscular, autoimmune and infectious diseases;
  • Age between 50 to 75 years;
  • Signature of the Informed Consent Term.
  • No hyperreactivity during the pre-intervention evaluation tests;
  • No chronic renal failure; history of malignant disease with life expectancy \<2 years;
  • No severe arrhythmias, angina pectoris, pulmonary embolism and thrombophlebitis;
  • Do not have orthopedic limitations or any physical or mental limitation that prevents the proposed exercises from being performed;
  • Present Left Ventricular Ejection Fraction (LVEF) \> 40% in 48h after CABG, and
  • After the physical training period, individuals who have not completed a minimum of 80% of the protocol will be excluded from the sample due to refusal or withdrawal.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bruna Eibel

Porto Alegre, Brazil

Location

Related Publications (2)

  • ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. doi: 10.1164/ajrccm.166.1.at1102. No abstract available.

    PMID: 12091180BACKGROUND

  • Thijssen DH, Black MA, Pyke KE, Padilla J, Atkinson G, Harris RA, Parker B, Widlansky ME, Tschakovsky ME, Green DJ. Assessment of flow-mediated dilation in humans: a methodological and physiological guideline. Am J Physiol Heart Circ Physiol. 2011 Jan;300(1):H2-12. doi: 10.1152/ajpheart.00471.2010. Epub 2010 Oct 15.

    PMID: 20952670BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2017

First Posted

March 30, 2017

Study Start

April 1, 2017

Primary Completion

October 1, 2018

Study Completion

October 1, 2018

Last Updated

August 7, 2019

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)