Acute Myocardial Infarction: Rehabilitation PhaseNCT02758600
Cardiopulmonary and Metabolic Responses to Early Exercise in Patients After Coronary Arterial Bypass Grafting
A study testing Cycle ergometer exercise rehabilitation protocol in people with Acute Myocardial Infarction: Rehabilitation Phase and Coronary Artery Bypass Graft Triple Vessel, run by Federal University of São Paulo at 1 site in Brazil.
Trial summary
Coronary arterial bypass graft surgery (CABG) is proven safe with improved survival and greater quality of life in patients with coronary arterial disease. Evidences on the cardiovascular and gas-exchanges responses during and right after early exercise-based rehabilitation of this patients are limited. Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Acute Myocardial Infarction: Rehabilitation Phase, Coronary Artery Bypass Graft Triple Vessel, Physical Activity
- What is being tested?
- Cycle ergometer exercise rehabilitation protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2016to Dec 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
- Age between 35 to 75 years old;
- Coronary arterial disease proved by coronary angiography
- Elective Coronary arterial bypass grafting
Who cannot join
- Pulmonary chronic disease
- Disabling neurological or orthopedic disease
- Morbidity obesity
- Urgency surgery
- Bilateral pleural opening
- Arrhythmias during exercise protocol
- Prolonged mechanical ventilation (>12 hours)
- Inability to comprehend or perform the tests
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Universitary Hospital of Federal University of Sao Paulo
São Paulo, São Paulo, 04020040
Isadora s Rocco, Miss, +55 11 958506717
About this study
Official title: Cardiopulmonary and Metabolic Responses in Early Exercise-based Rehabilitation in Patients With or Without Left Ventricular Dysfunction After Coronary Arterial Bypass Grafting
Coronary arterial bypass graft surgery (CABG) is proven safe with improved survival and greater quality of life in patients with coronary arterial disease. Evidences on the cardiovascular and gas-exchanges responses during and right after early exercise-based rehabilitation of this patients are limited. Objective: The investigators aim to analyse breath-by-breath cardiopulmonary and metabolic responses during six-minute walk test (6MWT) and shuttle walk test (SWT) in patients with or without left ventricular dysfunction (LVD) after CABG. In addition, the investigators will investigate oxygen consumption and cardiopulmonary responses during the early exercise-based rehabilitation in the first days after surgery. Methods: According to the left ventricular ejection fraction (LVEF), subjects will be allocated into two groups: with LVD (LVEF < 45%) and without LVD (LVEF > 45%). Patients will be submitted to the 6MWT and SWT linked to portable spirometric-telemetric device before and 6 days after CABG. During the first days after surgery, patients will be evaluated about pulmonary function and respiratory strenght at rest and oxygen consumption during the portable cycle ergometer protocol. Clinical outcomes as time to hospital discharge, pulmonary complications and occurence of arrythmias will be assessed during inpatient time until hospital discharge. Incidence of mortality, hospital readmission and angina recurrence will be evaluated in a one-year follow up.
- Conditions
- Acute Myocardial Infarction: Rehabilitation Phase, Coronary Artery Bypass Graft Triple Vessel, Physical Activity
- Being tested
- Cycle ergometer exercise rehabilitation protocol
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cycle ergometer exercise rehabilitation protocolOther
Patients will be submitted to a progressive and moderate exercise protocol with a portable cycle ergometer.
| Study group | Role | What they receive |
|---|---|---|
| LVEF < 45% | Experimental | Patients with left ventricular dysfunction will be evaluated before and 6 days after after coronary arterial bypass graft surgery. Postoperatively, subjects will be submitted to a portable cycle ergometer exercise protocol from the first day until hospital discharge. Receives: Other: Cycle ergometer exercise rehabilitation protocol |
| LVEF > 45% | Experimental | Patients without left ventricular dysfunction will be evaluated before and 6 days after after coronary arterial bypass graft surgery. Postoperatively, subjects will be submitted to a portable cycle ergometer exercise protocol from the first day until hospital discharge. Receives: Other: Cycle ergometer exercise rehabilitation protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Six-minute walk test to measure functional capacity
According to the preoperative six-minute walk test linked to portable ergoespirometry device, we will evaluate the decrease in functional capacity in the sixth day after surgery.
Measured: 6 days
Short-term complications
Incidence of arrythmias, pulmonary complications (pleural effusion, pulmonary atelectasis and pneumonia)
Measured: Until hospital discharge, an average of 15 days
Shuttle walk test to measure functional capacity
According to the preoperative shuttle walk test linked to portable ergoespirometry device, we will evaluate the decrease in functional capacity in the sixth day after surgery.
Measured: 6 days
Secondary outcomes (4)
Pulmonary Dysfunction
By spirometry, assessing the decrease in forced vital capacity and changes in exhaled volume forced in first second postoperativetly compare to preoperative period.
Measured: 6 days (on the 1th, 3th and 6th day after surgery)
Respiratory weakness
By manovacuometry, assessing the change in inspiratory muscle pressure and expiratory muscle pressure postoperativetly compare to preoperative period.
Measured: 6 days (on the 1th, 3th and 6th day after surgery)
Oxygen Consumption
Evaluate the oxygen consumption in metabolic equivalents (METS) during the cycle ergometer in post operative period by using spirometic-telemetric portable device during sessions.
Measured: First 6 days after surgery
Mid and Long Term Complications
Complications such as angina recurrence, hospital readmission, cardiac events and all cause mortality.
Measured: 3 months to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2016 (estimated)
- Study startMar 2016
- Primary completionNov 2016 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myocardial Infarction: Rehabilitation PhaseStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Isadora Salvador Rocco, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02758600
- Sponsor's protocol ID
- 53016216.3.0000.5505
- Status last verified
- Aug 2016
- First submitted
- 23 Apr 2016
- Last updated
- 17 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiopulmonary and Metabolic Responses in Early Exercise-based Rehabilitation in Patients With or Without Left Ventricular Dysfunction After Coronary Arterial Bypass Grafting
- ClinicalTrials.gov ID
- NCT02758600
- Acronym / sponsor ID
- 53016216.3.0000.5505
- Conditions
- Acute Myocardial Infarction: Rehabilitation Phase, Coronary Artery Bypass Graft Triple Vessel, Physical Activity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Nov 2016 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 2 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.
Coronary arterial bypass graft surgery (CABG) is proven safe with improved survival and greater quality of life in patients with coronary arterial disease. Evidences on the cardiovascular and gas-exchanges responses during and right after early exercise-based rehabilitation of this patients are limited. Objective: The investigators aim to analyse breath-by-breath cardiopulmonary and metabolic responses during six-minute walk test (6MWT) and shuttle walk test (SWT) in patients with or without left ventricular dysfunction (LVD) after CABG. In addition, the investigators will investigate oxygen consumption and cardiopulmonary responses during the early exercise-based rehabilitation in the first days after surgery. Methods: According to the left ventricular ejection fraction (LVEF), subjects will be allocated into two groups: with LVD (LVEF < 45%) and without LVD (LVEF > 45%). Patients will be submitted to the 6MWT and SWT linked to portable spirometric-telemetric device before and 6 days after CABG. During the first days after surgery, patients will be evaluated about pulmonary function and respiratory strenght at rest and oxygen consumption during the portable cycle ergometer protocol. Clinical outcomes as time to hospital discharge, pulmonary complications and occurence of arrythmias will be assessed during inpatient time until hospital discharge. Incidence of mortality, hospital readmission and angina recurrence will be evaluated in a one-year follow up.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LVEF < 45% | Experimental | Other: Cycle ergometer exercise rehabilitation protocolPatients with left ventricular dysfunction will be evaluated before and 6 days after after coronary arterial bypass graft surgery. Postoperatively, subjects will be submitted to a portable cycle ergometer exercise protocol from the first day until hospital discharge. |
| LVEF > 45% | Experimental | Other: Cycle ergometer exercise rehabilitation protocolPatients without left ventricular dysfunction will be evaluated before and 6 days after after coronary arterial bypass graft surgery. Postoperatively, subjects will be submitted to a portable cycle ergometer exercise protocol from the first day until hospital discharge. |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age between 35 to 75 years old;
- Coronary arterial disease proved by coronary angiography
- Elective Coronary arterial bypass grafting
Key exclusion criteria (8 listed)
- Pulmonary chronic disease
- Disabling neurological or orthopedic disease
- Morbidity obesity
- Urgency surgery
- Bilateral pleural opening
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 |
|---|---|---|
| Cycle ergometer exercise rehabilitation protocolPatients will be submitted to a progressive and moderate exercise protocol with a portable cycle ergometer. | Other | LVEF < 45%, LVEF > 45% |
Primary outcome
Six-minute walk test to measure functional capacity
Time frame: 6 days
According to the preoperative six-minute walk test linked to portable ergoespirometry device, we will evaluate the decrease in functional capacity in the sixth day after surgery.
Short-term complications
Time frame: Until hospital discharge, an average of 15 days
Incidence of arrythmias, pulmonary complications (pleural effusion, pulmonary atelectasis and pneumonia)
Shuttle walk test to measure functional capacity
Time frame: 6 days
According to the preoperative shuttle walk test linked to portable ergoespirometry device, we will evaluate the decrease in functional capacity in the sixth day after surgery.
4 secondary outcomes
Pulmonary Dysfunction
Time frame: 6 days (on the 1th, 3th and 6th day after surgery)
Respiratory weakness
Time frame: 6 days (on the 1th, 3th and 6th day after surgery)
Oxygen Consumption
Time frame: First 6 days after surgery
Mid and Long Term Complications
Time frame: 3 months to 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2016.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cycle ergometer exercise rehabilitation protocol in people with Acute Myocardial Infarction: Rehabilitation Phase and Coronary Artery Bypass Graft Triple Vessel, 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 3 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 17 Aug 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 Isadora S Rocco, Miss (+55 11 958506717, isarocco@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Six-minute walk test to measure functional capacity (time frame: 6 days). The study lists 3 primary outcomes in all. 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 17 Aug 2016.