Complication of CABGPhase 3NCT01410253
Effects of Cardiac Rehabilitation on Postoperatory of Coronary Artery Bypass Graft.
A Phase 3 study testing Combination of four techniques of physiotherapy, Combination of three techniques of physiotherapy and Combination of two techniques of physiotherapy in people with Complication of CABG, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial summary
Randomized Clinical Trial to evaluate the use of different techniques of physical therapy on recovery of functional capacity, pulmonary function and respiratory muscle strength in the period of hospital stay after coronary artery bypass graft. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Complication of CABG
- What is being tested?
- Combination of four techniques of physiotherapy, Combination of three techniques of physiotherapy and Combination of two techniques of physiotherapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2011to Mar 2016
- Phase
- Phase 3
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- -Patients are recruited from the waiting list for a first CABG intervention at the Porto Alegre Clinical Hospital.
Who cannot join
- chronic renal failure,
- unstable angina,
- moderate or severe valve disease,
- complex cardiac arrhythmia,
- stroke,
- inability to exercise the lower limbs,
- subjects with forced expiratory volume in 1 second less than 70% of predicted
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effects of Different Physical Therapy on Cardiac Rehabilitation in Post Operatory Period of Coronary Artery Bypass Graft: Randomized Clinical Trial.
Randomized Clinical Trial to evaluate the use of different techniques of physical therapy on recovery of functional capacity, pulmonary function and respiratory muscle strength in the period of hospital stay after coronary artery bypass graft.
- Conditions
- Complication of CABG
- Being tested
- Combination of four techniques of physiotherapy, Combination of three techniques of physiotherapy, Combination of two techniques of physiotherapy, standard therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combination of four techniques of physiotherapyOther
The patients receive conventional physiotherapy, expiratory positive airway pressure, inspiratory muscle training and physical exercise. Twice daily for seven days
Combination of three techniques of physiotherapyOther
Patients receive conventional physiotherapy, expiratory positive airway pressure and physical exercise. Twice daily for seven days
Combination of two techniques of physiotherapyOther
Patients receive conventional physiotherapy,expiratory positive airway pressure respiratory muscle training. Twice daily for seven days
standard therapyOther
Patients receive conventional physiotherapy and expiratory positive airway pressure. Twice daily for seven days
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Not described Receives: Other: Combination of four techniques of physiotherapy |
| Group 2 | Experimental | Not described Receives: Other: Combination of three techniques of physiotherapy |
| Group 3 | Experimental | Not described Receives: Other: Combination of two techniques of physiotherapy |
| Group 4 | Placebo comparator | Not described Receives: Other: standard therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
submaximal functional capacity
functional capacity evaluated by six-minute walk test
Measured: Change from Baseline in functional capacity at seven days and thirty days after surgery
Secondary outcomes (3)
capacity functional
cardiopulmonary exercise testing ( VO2)
Measured: evaluated 40 days after surgery
respiratory muscle strength
Both PImax and PEmax were obtained using a pressure transducer
Measured: Change from Baseline in respiratory muscle strength at seven days and thirty days after surgery
lung function
assessed by spirometry (FVC and FEV1)
Measured: Change from Baseline in lung function at seven days and thirty 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 Aug 2011 (estimated)
- Study startJan 2011
- Primary completionNov 2015
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complication of CABGStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maurice Zanini, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01410253
- Sponsor's protocol ID
- GPPG090650
- Status last verified
- Mar 2016
- First submitted
- 10 May 2011
- Last updated
- 22 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Different Physical Therapy on Cardiac Rehabilitation in Post Operatory Period of Coronary Artery Bypass Graft: Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT01410253
- Acronym / sponsor ID
- GPPG090650
- Conditions
- Complication of CABG
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Nov 2015 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 5 Aug 2011 (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.
Randomized Clinical Trial to evaluate the use of different techniques of physical therapy on recovery of functional capacity, pulmonary function and respiratory muscle strength in the period of hospital stay after coronary artery bypass graft.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Other: Combination of four techniques of physiotherapy |
| Group 2 | Experimental | Other: Combination of three techniques of physiotherapy |
| Group 3 | Experimental | Other: Combination of two techniques of physiotherapy |
| Group 4 | Placebo comparator | Other: standard therapy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -Patients are recruited from the waiting list for a first CABG intervention at the Porto Alegre Clinical Hospital.
Key exclusion criteria (7 listed)
- chronic renal failure,
- unstable angina,
- moderate or severe valve disease,
- complex cardiac arrhythmia,
- stroke,
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 |
|---|---|---|
| Combination of four techniques of physiotherapyThe patients receive conventional physiotherapy, expiratory positive airway pressure, inspiratory muscle training and physical exercise. Twice daily for seven days | Other | Group 1 |
| Combination of three techniques of physiotherapyPatients receive conventional physiotherapy, expiratory positive airway pressure and physical exercise. Twice daily for seven days | Other | Group 2 |
| Combination of two techniques of physiotherapyPatients receive conventional physiotherapy,expiratory positive airway pressure respiratory muscle training. Twice daily for seven days | Other | Group 3 |
| standard therapyPatients receive conventional physiotherapy and expiratory positive airway pressure. Twice daily for seven days | Other | Group 4 |
Primary outcome
submaximal functional capacity
Time frame: Change from Baseline in functional capacity at seven days and thirty days after surgery
functional capacity evaluated by six-minute walk test
3 secondary outcomes
capacity functional
Time frame: evaluated 40 days after surgery
respiratory muscle strength
Time frame: Change from Baseline in respiratory muscle strength at seven days and thirty days after surgery
lung function
Time frame: Change from Baseline in lung function at seven days and thirty days after 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 22 Mar 2016.
Related trials for Complication of CABG
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
Enrolling by invitation
Feasibility of Physical Prehabilitation for High-Risk Patients Undergoing Cardiac Surgery Via Sternotomy
Prehabilitation, Cardiac Surgery
Not yet recruiting
Bilateral Pecto-Intercostal Fascial Plane Block for Prevention of Chronic Poststernotomy Pain After CABG
Chronic Poststernotomy Pain
Not yet recruiting
BrainProtect-guided, Real-time Cerebral Autoregulation Monitoring and Protection of Brain During Cardiac Surgery With Cardiopulmonary Bypass Requiring Heart-lung Machine
Cerebral Autoregulation Impairment, Postoperative Cognitive Dysfunction
Not yet recruiting
Parasternal Intercostal Nerve Block and Chronic Pain After Cardiac Surgery
Chronic Postoperative Pain, Chronic Post-Sternotomy Pain
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 Phase 3 study testing Combination of four techniques of physiotherapy, Combination of three techniques of physiotherapy and Combination of two techniques of physiotherapy in people with Complication of CABG, run by Hospital de Clinicas de Porto Alegre 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 1 inclusion and 7 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 22 Mar 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
submaximal functional capacity (time frame: Change from Baseline in functional capacity at seven days and thirty days after surgery). 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 22 Mar 2016.