Coronary Artery Bypass SurgeryNCT00670176
Pre- and Postoperative Cardiopulmonary Rehabilitation Reduces Complications After Coronary Artery Bypass Surgery: A Randomized Trial
A study testing REHAB (Pre- and postoperative cardiopulmonary rehabilitation) in people with Coronary Artery Bypass Surgery, run by Universidade do Sul de Santa Catarina.
Trial summary
Pre- and postoperative cardiopulmonary rehabilitation reduces complications after coronary artery bypass surgery. This study was conducted as a randomized trial to verify this hypothesis in our institution. ICSC Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronary Artery Bypass Surgery
- What is being tested?
- REHAB (Pre- and postoperative cardiopulmonary rehabilitation)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- No sites listed yet
- Study dates
- Start not givento Jun 2005
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All CAB patients
Who cannot join
- SCA in the previous 24h and incapacity of doing light exercise. Valvular patients
About this study
Pre- and postoperative cardiopulmonary rehabilitation reduces complications after coronary artery bypass surgery. This study was conducted as a randomized trial to verify this hypothesis in our institution. ICSC
- Conditions
- Coronary Artery Bypass Surgery
- Being tested
- REHAB (Pre- and postoperative cardiopulmonary rehabilitation)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REHAB (Pre- and postoperative cardiopulmonary rehabilitation)Behavioural
| Study group | Role | What they receive |
|---|---|---|
| I | Experimental | Not described Receives: Behavioral: REHAB (Pre- and postoperative cardiopulmonary rehabilitation) |
What is being measured
The primary outcome is the main question the study is designed to answer.
length of stay in the ICU (in minutes); days on the ward after ICU until hospital discharge; pneumonia with the need for antibiotic treatment; and atrial fibrillation or flutter detected on daily-performed electrocardiograms
Secondary outcomes (1)
time until oro-tracheal tube (OTT) removal, occurrence of pleural effusion, atelectasis, change in peak-flow (baseline vs. 2 hours after extubation vs. discharge), and changes in the 6-minute-walking distance between enrollment and hospital discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2008 (estimated)
- Study completionJun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery Bypass 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
- Single group
- Masking
- None (open label)
- Enrolment
- 56 participants
Sponsor and investigators
- Lead sponsor
- Universidade do Sul de Santa Catarina
- Sponsor type
- Other government
- Collaborators
- ICSC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00670176
- Sponsor's protocol ID
- ICSC01
- Status last verified
- Apr 2008
- First submitted
- 29 Apr 2008
- Last updated
- 1 May 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre- and Postoperative Cardiopulmonary Rehabilitation Reduces Complications After Coronary Artery Bypass Surgery: A Randomized Trial
- ClinicalTrials.gov ID
- NCT00670176
- Acronym / sponsor ID
- ICSC01
- Conditions
- Coronary Artery Bypass Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants
- Lead sponsor
- Universidade do Sul de Santa CatarinaOther government
- Collaborators
- ICSC
- Study completion
- Jun 2005 (actual)
- First posted
- 1 May 2008 (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.
Pre- and postoperative cardiopulmonary rehabilitation reduces complications after coronary artery bypass surgery. This study was conducted as a randomized trial to verify this hypothesis in our institution. ICSC
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| I | Experimental | Behavioral: REHAB (Pre- and postoperative cardiopulmonary rehabilitation) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All CAB patients
Key exclusion criteria (1 listed)
- SCA in the previous 24h and incapacity of doing light exercise. Valvular patients
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 |
|---|---|---|
| REHAB (Pre- and postoperative cardiopulmonary rehabilitation) | Behavioural | I |
Primary outcome
length of stay in the ICU (in minutes); days on the ward after ICU until hospital discharge; pneumonia with the need for antibiotic treatment; and atrial fibrillation or flutter detected on daily-performed electrocardiograms
1 secondary outcome
time until oro-tracheal tube (OTT) removal, occurrence of pleural effusion, atelectasis, change in peak-flow (baseline vs. 2 hours after extubation vs. discharge), and changes in the 6-minute-walking distance between enrollment and hospital discharge.
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 1 May 2008.
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Coronary Artery Bypass Graft (CABG)
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.
Questions about this trial
What is this clinical trial studying?
A study testing REHAB (Pre- and postoperative cardiopulmonary rehabilitation) in people with Coronary Artery Bypass Surgery, run by Universidade do Sul de Santa Catarina.
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 1 May 2008. 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?
length of stay in the ICU (in minutes); days on the ward after ICU until hospital discharge; pneumonia with the need for antibiotic treatment; and atrial fibrillation or flutter detected on daily-performed electrocardiograms. 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 1 May 2008.