Coronary Artery Bypass GraftingCEFREETNCT03096158
Cardiac and Endothelial Function Response to Early Exercise Training After Coronary Artery Bypass Surgery
A study testing Ventilatory Muscle Training (TREMVEN), Aerobic Training (AERO) and Isometric Handgrip Training (ISO) in people with Coronary Artery Bypass Grafting and Coronary Artery Disease, run by Instituto de Cardiologia do Rio Grande do Sul at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Coronary Artery Bypass Grafting, Coronary Artery Disease, Cardiac Rehabilitation
- What is being tested?
- Ventilatory Muscle Training (TREMVEN), Aerobic Training (AERO) and Isometric Handgrip Training (ISO)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Apr 2017to 1 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cardiac and Endothelial Function Response to Early Exercise Training (CEFREET Study) After Coronary Artery Bypass Surgery: a Randomized Clinical Trial
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.
- Being tested
- Ventilatory Muscle Training (TREMVEN), Aerobic Training (AERO), Isometric Handgrip Training (ISO)
- Keywords
- Coronary artery bypass grafting, Cardiorespiratory rehabilitation, Functional electrical stimulation, Inspiratory muscle training, Aerobic training, Isometric handgrip training, Functional capacity, Endothelial function, Cardiac function
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Isometric Handgrip Training (ISO) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Pre and post (7 days) coronary artery bypass surgery
Secondary outcomes (6)
Cardiac Function - Echocardiography
A high resolution ultrasound device equipped with a 2-5 megahertz (MHz) transducer will be used to obtain two-dimensional echocardiographic parameters: left ventricular end-diastolic volume, left ventricular end-systolic volume, left ventricular ejection fraction (cardiac function). The images will be stored on the hard disk of the echocardiographic device and analyzed offline in specific software of the equipment itself.
Measured: Pre and post (7 days) coronary artery bypass surgery
Endothelial Function- Flow-Mediated Dilation (FMD)
To examine brachial artery FMD, the arm will be extended and positioned at an angle of ~80° from the torso. A rapid inflation and deflation pneumatic cuff will be positioned on the forearm to provide an ischemia. A 10-MHz multi-frequency linear array probes, attached to a high resolution ultrasound machine, will be then used to image the brachial artery in the distal 1⁄3rd of the upper arm. Following baseline assessments, the forearm cuff will be inflated ( > 200 mmHg) for 5 minutes. Diameter and flow recordings resumed 30s prior to cuff deflation and continued for 3 minutes.
Measured: Pre and post (7 days) coronary artery bypass surgery
Femoral Quadriceps Perimetry
Quadriceps perimetry will be measured every 5 cm, starting from the top edge of the patella in the proximal direction. Thus, measurements of 5, 10, 15 and 20 cm will be performed in both lower limbs.
Measured: Pre and post (7 days) coronary artery bypass surgery
Maximal Inspiratory Pressure
Inspiratory muscle function testing will be performed using a pressure transducer (MVD-300), connected to a system with two unidirectional valves. PImax will be determined in deep inspiration from residual volume against an occluded airway with a minor air leak (2 mm). The highest pressure of six measurements (with less than 5% difference) will be used to define PImax.
Measured: Pre and post (7 days) coronary artery bypass surgery
Handgrip Strength
A digital handgrip device will be held while sitting upright in a chair with feet flat on the floor and 5 maximal contractions of the hand flexor muscles with each hand will be performed to determine maximum voluntary contraction (MVC). 30% of MVC will be used to isometric handgrip resistance exercise.
Measured: Pre and post (7 days) coronary artery bypass surgery
ELISA Immunoassay
A venous blood sample will be collected pre- and post-intervention. After centrifugation at 1.000 rpm for 10 min at 4 C, the plasma will be separated and stored at 80 C until assay. VEGF and inflammatory markers will be analyzed.
Measured: Pre and post (7 days) coronary artery bypass surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2017
- Study start1 Apr 2017
- Primary completion1 Oct 2018
- Study completion1 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery Bypass GraftingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Cardiologia do Rio Grande do Sul
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03096158
- Sponsor's protocol ID
- CEFREET
- Acronym
- CEFREET
- Status last verified
- Jul 2018
- First submitted
- 16 Mar 2017
- Last updated
- 7 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 12091180Thijssen 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.
PubMed 20952670
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac and Endothelial Function Response to Early Exercise Training (CEFREET Study) After Coronary Artery Bypass Surgery: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03096158
- Acronym / sponsor ID
- CEFREET / CEFREET
- Keywords
- Coronary artery bypass grafting, Cardiorespiratory rehabilitation, Functional electrical stimulation, Inspiratory muscle training, Aerobic training, Isometric handgrip training, Functional capacity, Endothelial function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Instituto de Cardiologia do Rio Grande do SulUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 1 Oct 2018 (actual)
- Study completion
- 1 Oct 2018 (actual)
- First posted
- 30 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ventilatory Muscle Training (TREMVEN) | Experimental | Other: Ventilatory Muscle Training (TREMVEN)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. |
| Aerobic Training (AERO) | Experimental | Other: Aerobic Training (AERO)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. |
| Isometric Handgrip Training (ISO) | Experimental | Other: Isometric Handgrip Training (ISO)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. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ventilatory Muscle Training (TREMVEN)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. | Other | Ventilatory Muscle Training (TREMVEN) |
| Aerobic Training (AERO)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. | Other | Aerobic Training (AERO) |
| Isometric Handgrip Training (ISO)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. | Other | Isometric Handgrip Training (ISO) |
Primary outcome
Functional Capacity - Six-Minute Walk Test (6MWT)
Time frame: Pre and post (7 days) coronary artery bypass surgery
The 6MWT will be performed to assess functional capacity following the guidelines proposed by the American Thoracic Society.
6 secondary outcomes
Cardiac Function - Echocardiography
Time frame: Pre and post (7 days) coronary artery bypass surgery
Endothelial Function- Flow-Mediated Dilation (FMD)
Time frame: Pre and post (7 days) coronary artery bypass surgery
Femoral Quadriceps Perimetry
Time frame: Pre and post (7 days) coronary artery bypass surgery
Maximal Inspiratory Pressure
Time frame: Pre and post (7 days) coronary artery bypass surgery
Handgrip Strength
Time frame: Pre and post (7 days) coronary artery bypass surgery
ELISA Immunoassay
Time frame: Pre and post (7 days) coronary artery bypass surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2019.
- Background: PubMed 12091180ATS 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.
- Background: PubMed 20952670Thijssen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ventilatory Muscle Training (TREMVEN), Aerobic Training (AERO) and Isometric Handgrip Training (ISO) in people with Coronary Artery Bypass Grafting and Coronary Artery Disease, run by Instituto de Cardiologia do Rio Grande do Sul at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Capacity - Six-Minute Walk Test (6MWT) (time frame: Pre and post (7 days) coronary artery bypass surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03096158, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2019; AzTrials last refreshed its copy on 29 Oct 2026.