Disorder; Heart, Functional, Postoperative, Cardiac SurgeryNCT02763774
Effects a Rehabilitation Program in Patients With Left Ventricular Dysfunction After Coronary Artery Bypass Grafting
A study testing Walking exercise, Stationary cycling exercise and Neuromuscular electrical stimulation in people with Disorder; Heart, Functional, Postoperative, Cardiac Surgery, run by Federal University of São Paulo at 1 site in Brazil.
Trial summary
This study aims to analyze effects of three types of cardiac rehabilitation protocol on fuctional capacity, inflammatory markers, pulmonary function and clinical outcomes after coronary artery bypass grafting (CABG) in patients with left ventricular disfunction. Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Disorder; Heart, Functional, Postoperative, Cardiac Surgery
- What is being tested?
- Walking exercise, Stationary cycling exercise and Neuromuscular electrical stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteBrazil
- Study dates
- Jun 2014to Jun 2017
- 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 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Coronary artery disease proven by coronary angiography;
- Elective CABG;
- No acute or chronic pulmonary disease;
- Patients after surgery, keep in spontaneous ventilation on first postoperative day;
- Absence of neurological, neuromuscular, musculoskeletal and osteoarticular incapacitating;
- Consent form signed for participation in the survey.
Who cannot join
- Inability to perform spirometry;
- Presence of acute lung disease or chronic;
- Surgical indication of urgency;
- Morbid obesity;
- Hemodynamics instability at the time of spirometry or during six minutes walking test;
- Intraoperative death or until the sixth postoperative day;
- Patients remaining in mechanical prolonged ventilation for more than 12 hours;
- Severe cardiac arrhythmia during application of assessment protocols and exercises (ventricular tachycardia, atrioventricular block second or degree) any other condition the investigator's discretion put the patient at increased risk with beginning of the year; Any change that may lead to failure of proposed protocols.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Federal University of Sao Paulo
São Paulo, São Paulo, 04023062
Solange Guizilini, PhD, +5511982887753, s_guizilini@yahoo.com.br
About this study
Official title: Effects of Exercise Rehabilitation Program at Hospitalar Fase on Inflammatory Markers, Functional Capacity and Clinical Outcomes in Patients With Left Ventricular Dysfunction After Coronary Artery Bypass Grafting
This study aims to analyze effects of three types of cardiac rehabilitation protocol on fuctional capacity, inflammatory markers, pulmonary function and clinical outcomes after coronary artery bypass grafting (CABG) in patients with left ventricular disfunction. Patients will be randomized and allocated in three groups according to type of exercise protocol: 1. walk; 2. cycle; 3. functional electrical stimulation.
Read the detailed description
Several studies have been demonstrated beneficial effects of exercise to minimize impact of CABG. However, there is no consensus on what kind of exercise is safe and effective for patients with left ventricular dysfunction.
Walking
- Being tested
- Walking exercise, Stationary cycling exercise, Neuromuscular electrical stimulation
- Keywords
- coronary artery bypass, sistemic inflammatory response syndrome, left ventricular dysfunction, postoperative complications, physical fitness
- Medical subject headings
- Ventricular Dysfunction, Left, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Walking exerciseOther
Participants will be sumitted to progressive exercises and supervised by a physiotherapist, active-assisted to free active exercise in upper and lower limbs, stationary running and walking. The intensity of walk will be determined by the Borg's sujective effort perception scale - (modified from zero to 10). On first postoperative day, participants will perform exercises in supine position. From the second to the fifth postoperative day, they will perform progressive walking.
Stationary cycling exerciseOther
Participants will be sumitted to progressive exercises and supervised by a physiotherapist, active-assisted to free active exercise in upper and lower limbs. From the first to the fifth postoperative day, they will perform progressive cycling exercise.The intensity of cycling will be determined by the Borg's sujective effort perception scale - (modified from zero to 10).
Neuromuscular electrical stimulationOther
Participants will be sumitted to progressive exercises and supervised by a physiotherapist, active-assisted to free active exercise in upper and lower limbs. From the first to the fifth postoperative day, quadriceps and gastrocnemius muscles will be percutaneous stimulated with the following parameters: Synchronic mode, 50Hz, 400uS, time on 10s, time off 20s, intensity as tolerated by the patient.
| Study group | Role | What they receive |
|---|---|---|
| Walking exercise | Experimental | Participants will be sumitted to progressive exercises and supervised by a physiotherapist, active-assisted to free active exercise in upper and lower limbs, stationary running and walking. The intensity of walk will be determined by the Borg's sujective effort perception scale - (modified from zero to 10). On first postoperative day, participants will perform exercises in supine position. From the second to the fifth postoperative day, they will perform progressive walking. Receives: Other: Walking exercise |
| Stationary cycling exercise | Experimental | Participants will be sumitted to progressive exercises and supervised by a physiotherapist, active-assisted to free active exercise in upper and lower limbs. From the first to the fifth postoperative day, they will perform progressive cycling exercise.The intensity of cycling will be determined by the Borg's sujective effort perception scale - (modified from zero to 10). Receives: Other: Stationary cycling exercise |
| Neuromuscular electrical stimulation | Experimental | Participants will be sumitted to progressive exercises and supervised by a physiotherapist, active-assisted to free active exercise in upper and lower limbs. From the first to the fifth postoperative day, quadriceps and gastrocnemius muscles will be percutaneous stimulated with the following parameters: Synchronic mode, 50Hz, 400uS, time on 10s, time off 20s, intensity as tolerated by the patient. Receives: Other: Neuromuscular electrical stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Capacity
Participants will be submitted to six minute walk test on preoperative period and sixth postoperative day (or before hospital discharge) to evaluate functional capacity. The test will be performed with a mobile device to measure metabolic response to exercise (Oxycon™ Mobile).
Measured: Up to ten days after surgery, at hospital discharge.
Secondary outcomes (1)
Inflammatory markers
Blood sample will be collected to measure inflammatory markers (TNF-alpha and interleukins) and to compare exercise effects on inflammatory response after surgery.
Measured: in-hospital postoperative period, up to ten days after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2016 (estimated)
- Study startJun 2014
- Primary completionMay 2016 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disorder; Heart, Functional, Postoperative, Cardiac SurgeryStudies 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
- Investigator
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Solange Guizilini, Federal University of São Paulo
- Investigators
- Solange Guizilini, PhD, Principal investigator, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02763774
- Sponsor's protocol ID
- 31295914.0.0000.5505
- Status last verified
- May 2016
- First submitted
- 13 Apr 2016
- Last updated
- 5 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Exercise Rehabilitation Program at Hospitalar Fase on Inflammatory Markers, Functional Capacity and Clinical Outcomes in Patients With Left Ventricular Dysfunction After Coronary Artery Bypass Grafting
- ClinicalTrials.gov ID
- NCT02763774
- Acronym / sponsor ID
- 31295914.0.0000.5505
- Keywords
- coronary artery bypass, sistemic inflammatory response syndrome, left ventricular dysfunction, postoperative complications, physical fitness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- May 2016 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 5 May 2016 (estimated)
- 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.
This study aims to analyze effects of three types of cardiac rehabilitation protocol on fuctional capacity, inflammatory markers, pulmonary function and clinical outcomes after coronary artery bypass grafting (CABG) in patients with left ventricular disfunction. Patients will be randomized and allocated in three groups according to type of exercise protocol: 1. walk; 2. cycle; 3. functional electrical stimulation.
Detailed description
Several studies have been demonstrated beneficial effects of exercise to minimize impact of CABG. However, there is no consensus on what kind of exercise is safe and effective for patients with left ventricular dysfunction.
Walking
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Walking exercise | Experimental | Other: Walking exerciseParticipants will be sumitted to progressive exercises and supervised by a physiotherapist, active-assisted to free active exercise in upper and lower limbs, stationary running and walking. The intensity of walk will be determined by the Borg's sujective effort perception scale - (modified from zero to 10). On first postoperative day, participants will perform exercises in supine position. From the second to the fifth postoperative day, they will perform progressive walking. |
| Stationary cycling exercise | Experimental | Other: Stationary cycling exerciseParticipants will be sumitted to progressive exercises and supervised by a physiotherapist, active-assisted to free active exercise in upper and lower limbs. From the first to the fifth postoperative day, they will perform progressive cycling exercise.The intensity of cycling will be determined by the Borg's sujective effort perception scale - (modified from zero to 10). |
| Neuromuscular electrical stimulation | Experimental | Other: Neuromuscular electrical stimulationParticipants will be sumitted to progressive exercises and supervised by a physiotherapist, active-assisted to free active exercise in upper and lower limbs. From the first to the fifth postoperative day, quadriceps and gastrocnemius muscles will be percutaneous stimulated with the following parameters: Synchronic mode, 50Hz, 400uS, time on 10s, time off 20s, intensity as tolerated by the patient. |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Coronary artery disease proven by coronary angiography;
- Elective CABG;
- No acute or chronic pulmonary disease;
- Patients after surgery, keep in spontaneous ventilation on first postoperative day;
- Absence of neurological, neuromuscular, musculoskeletal and osteoarticular incapacitating;
Key exclusion criteria (8 listed)
- Inability to perform spirometry;
- Presence of acute lung disease or chronic;
- Surgical indication of urgency;
- Morbid obesity;
- Hemodynamics instability at the time of spirometry or during six minutes walking test;
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 |
|---|---|---|
| Walking exerciseParticipants will be sumitted to progressive exercises and supervised by a physiotherapist, active-assisted to free active exercise in upper and lower limbs, stationary running and walking. The intensity of walk will be determined by the Borg's sujective effort perception scale - (modified from zero to 10). On first postoperative day, participants will perform exercises in supine position. From the second to the fifth postoperative day, they will perform progressive walking. | Other | Walking exercise |
| Stationary cycling exerciseParticipants will be sumitted to progressive exercises and supervised by a physiotherapist, active-assisted to free active exercise in upper and lower limbs. From the first to the fifth postoperative day, they will perform progressive cycling exercise.The intensity of cycling will be determined by the Borg's sujective effort perception scale - (modified from zero to 10). | Other | Stationary cycling exercise |
| Neuromuscular electrical stimulationParticipants will be sumitted to progressive exercises and supervised by a physiotherapist, active-assisted to free active exercise in upper and lower limbs. From the first to the fifth postoperative day, quadriceps and gastrocnemius muscles will be percutaneous stimulated with the following parameters: Synchronic mode, 50Hz, 400uS, time on 10s, time off 20s, intensity as tolerated by the patient. | Other | Neuromuscular electrical stimulation |
Primary outcome
Functional Capacity
Time frame: Up to ten days after surgery, at hospital discharge.
Participants will be submitted to six minute walk test on preoperative period and sixth postoperative day (or before hospital discharge) to evaluate functional capacity. The test will be performed with a mobile device to measure metabolic response to exercise (Oxycon™ Mobile).
1 secondary outcome
Inflammatory markers
Time frame: in-hospital postoperative period, up to ten days after surgery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2016.
- Individual participant dataSharing planned: Yes
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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.
Solange Guizilini, PhD principal investigator
Federal University of São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Walking exercise, Stationary cycling exercise and Neuromuscular electrical stimulation in people with Disorder; Heart, Functional, Postoperative, Cardiac Surgery, run by Federal University of São Paulo 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 6 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 5 May 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Solange Guizilini, PhD (+5511982887753, s_guizilini@yahoo.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Capacity (time frame: Up to ten days after surgery, at hospital discharge.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 May 2016.