Postoperative; Dysfunction Following Cardiac SurgeryNCT02312648
Impact of Mobilization on Cardiac Surgery
A study testing Interventional Group in people with Postoperative; Dysfunction Following Cardiac Surgery, run by Luciana Chiavegato.
Trial summary
The objective of this study is to investigate the effects of a program of early mobilization in the functional capacity in patients undergoing coronary artery bypass grafting in short and long- term. Read more about this study
- Who is it for?
- Ages 21 to 90 years
- Conditions the study is for
- Postoperative; Dysfunction Following Cardiac Surgery
- What is being tested?
- Interventional Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Nov 2016
- 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 21 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Consecutive patients admitted to elective and conventional coronary artery bypass, Body Mass Index (BMI) between 20 and 30 Kg/m2, mechanical ventilation time under than 24 hours, hemodynamic stability with or without use of positive inotropes, absence of arrhythmias and angina, mean arterial pressure (MAP) 60<PAM<100 mmHg, heart frequency (HR) 60<FC<100 bpm without signs of respiratory distress such as flaring nose, use of accessory muscles, thoracoabdominal asynchrony, respiratory frequency (f) ≤ 20 bpm without signs of infection were included in this study.
Who cannot join
- : presence of previous pulmonary disease, ejection fraction under 35% or longer than 54%, reoperation, intraoperative death or any contraindications to perform the proposed measurements and/or treatment.
About this study
Official title: Impact of an Early Mobilization Program on Functional Capacity After Coronary Artery Bypass Surgery: a Protocol of Randomized Controlled Trial.
The objective of this study is to investigate the effects of a program of early mobilization in the functional capacity in patients undergoing coronary artery bypass grafting in short and long- term.
Read the detailed description
The hypotheses this study is that patients if conduct the program of early mobilization during hospitalization achieve better performance in the walk test (distance) at hospital discharge and 60 days after the surgical procedure compared to patients who only carry out the program of respiratory exercises. Intervention and control groups will receive breathing exercises up to 24 hours postoperatively, and the intervention group will also receive early mobilization exercises.
- Being tested
- Interventional Group, Control group
- Keywords
- Functional Capacity, Physical Exertion, Patient Care, Early mobilization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interventional GroupOther
Respiratory exercises will be performed and subsequently active upper limb exercises will be conducted (flexion-extension and adduction-abduction) of large joints (shoulder, elbow and wrist) Associated with upper limb exercises, patients will undergo a series of exercises ergometer with lower limb (LL). The mobilization will be conducted on a cycle ergometer in an active, lasting 20 minutes, divided into three steps: heat 5 minutes; 10 minutes of low intensity exercise, with a speed of 30 revolutions per minute (rpm); and 5 minutes recovery. The patient remains in the supine position with the head of the bed elevated to 45 degrees, while the lower limbs will remain planned. After positioning the patient, the ergometer is adjusted.
Control groupOther
The patients will oriented to maintain sitting position and perform deep breaths (3 sets of 10 repetitions) in each session. They will receive the intervention once a day, for 30 minutes until 7th postoperative day. In addition, non invasive ventilation will be installed after orotracheal extubation for 30 to 60 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Early mobilization Group | Active comparator | Patients will perform deep breaths (3 sets of 10 repetitions), once a day, for 30 minutes until 7th postoperative day. Non invasive ventilation will be installed after orotracheal extubation for 30 to 60 minutes.Early mobilization protocol consist of upper and lower (cycle ergometer) limb exercises, chair transfer, deambulation for 10 to 20 minutes, step exercise (six times). Receives: Other: Interventional Group |
| Control Group - Respiratory exercise | Other | Respiratory exercises with patient sitting in bed with a high headboard 45, the same breathing exercises will be held Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Capacity
Patients will be submitted to six minute walking test
Measured: All patients will be evaluated on preoperative period ( when they arrived in the hospital to do the surgery), hospital discharge ( about a mean of two weeks afeter surgery) and 60 postoperative days in cargiology ambulatory
Secondary outcomes (2)
Intensive Care Unit (ICU) and Hospital length of stay
The number the days in ICU and hospital until discharge will be counted for each patient
Measured: All patients will be followed for the duration of hospital stay, an expected average of 30 days
Postoperative pulmonary complication (PPC)
The occurrence of PPC will be monitored until the day of hospital discharge by a physician blinded to the groups: pneumonia (chest radiography with pulmonary infiltrate associated with two of the following signs: purulent expectoration, temperature above 38.3º C and a greater than 25% increase in baseline leukocyte count with hyperthermia), atelectasis (RS associated with abnormal chest acute respiratory symptoms), hypoxemia (peripheral oxygen saturation associated with respiratory symptoms below 85%).
Measured: All patients will be followed for the duration of hospital stay, an expected average of 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2014 (estimated)
- Study startJan 2015
- Primary completionJun 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative; Dysfunction Following 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Luciana Chiavegato
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Luciana Chiavegato, Universidade Cidade de Sao Paulo
- Investigators
- Luciana D Chiavegato, PhD, Study director, Universidade Cidade de São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02312648
- Sponsor's protocol ID
- UNICID
- Status last verified
- Jun 2018
- First submitted
- 8 Nov 2014
- Last updated
- 7 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of an Early Mobilization Program on Functional Capacity After Coronary Artery Bypass Surgery: a Protocol of Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT02312648
- Acronym / sponsor ID
- UNICID
- Keywords
- Functional Capacity, Physical Exertion, Patient Care, Early mobilization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Luciana ChiavegatoUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 9 Dec 2014 (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.
The objective of this study is to investigate the effects of a program of early mobilization in the functional capacity in patients undergoing coronary artery bypass grafting in short and long- term.
Detailed description
The hypotheses this study is that patients if conduct the program of early mobilization during hospitalization achieve better performance in the walk test (distance) at hospital discharge and 60 days after the surgical procedure compared to patients who only carry out the program of respiratory exercises. Intervention and control groups will receive breathing exercises up to 24 hours postoperatively, and the intervention group will also receive early mobilization exercises.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early mobilization Group | Active comparator | Other: Interventional GroupPatients will perform deep breaths (3 sets of 10 repetitions), once a day, for 30 minutes until 7th postoperative day. Non invasive ventilation will be installed after orotracheal extubation for 30 to 60 minutes.Early mobilization protocol consist of upper and lower (cycle ergometer) limb exercises, chair transfer, deambulation for 10 to 20 minutes, step exercise (six times). |
| Control Group - Respiratory exercise | Other | Other: Control groupRespiratory exercises with patient sitting in bed with a high headboard 45, the same breathing exercises will be held |
Who may qualify
- Ages
- 21 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Consecutive patients admitted to elective and conventional coronary artery bypass, Body Mass Index (BMI) between 20 and 30 Kg/m2, mechanical ventilation time under than 24 hours, hemodynamic stability with or without use of positive inotropes, absence of arrhythmias and angina, mean arterial pressure (MAP) 60<PAM<100 mmHg, heart frequency (HR) 60<FC<100 bpm without signs of respiratory distress such as flaring nose, use of accessory muscles, thoracoabdominal asynchrony, respiratory frequency (f) ≤ 20 bpm without signs of infection were included in this study.
Key exclusion criteria (1 listed)
- : presence of previous pulmonary disease, ejection fraction under 35% or longer than 54%, reoperation, intraoperative death or any contraindications to perform the proposed measurements and/or treatment.
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 |
|---|---|---|
| Interventional GroupRespiratory exercises will be performed and subsequently active upper limb exercises will be conducted (flexion-extension and adduction-abduction) of large joints (shoulder, elbow and wrist) Associated with upper limb exercises, patients will undergo a series of exercises ergometer with lower limb (LL). The mobilization will be conducted on a cycle ergometer in an active, lasting 20 minutes, divided into three steps: heat 5 minutes; 10 minutes of low intensity exercise, with a speed of 30 revolutions per minute (rpm); and 5 minutes recovery. The patient remains in the supine position with the head of the bed elevated to 45 degrees, while the lower limbs will remain planned. After positioning the patient, the ergometer is adjusted. | Other | Early mobilization Group |
| Control groupThe patients will oriented to maintain sitting position and perform deep breaths (3 sets of 10 repetitions) in each session. They will receive the intervention once a day, for 30 minutes until 7th postoperative day. In addition, non invasive ventilation will be installed after orotracheal extubation for 30 to 60 minutes. | Other | Control Group - Respiratory exercise |
Primary outcome
Functional Capacity
Time frame: All patients will be evaluated on preoperative period ( when they arrived in the hospital to do the surgery), hospital discharge ( about a mean of two weeks afeter surgery) and 60 postoperative days in cargiology ambulatory
Patients will be submitted to six minute walking test
2 secondary outcomes
Intensive Care Unit (ICU) and Hospital length of stay
Time frame: All patients will be followed for the duration of hospital stay, an expected average of 30 days
Postoperative pulmonary complication (PPC)
Time frame: All patients will be followed for the duration of hospital stay, an expected average of 30 days
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 Jun 2018.
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.
Luciana D Chiavegato, PhD study director
Universidade Cidade de São Paulo
Questions about this trial
What is this clinical trial studying?
A study testing Interventional Group in people with Postoperative; Dysfunction Following Cardiac Surgery, run by Luciana Chiavegato.
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 1 inclusion and 1 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 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
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 (time frame: All patients will be evaluated on preoperative period ( when they arrived in the hospital to do the surgery), hospital discharge ( about a mean of two weeks afeter surgery) and 60 postoperative days in cargiology ambulatory). 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 7 Jun 2018; AzTrials last refreshed its copy on 7 Nov 2026.