Coronary Artery DiseasePhase 3NCT00873028
Evaluation of Inspiratory Muscle Strength Early After Coronary Artery Bypass
A Phase 3 study testing In Hospital Cardiopulmonary Rehabilitation in people with Coronary Artery Disease, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial summary
The purpose of this study is to evaluate the effects of a 6-day postoperative in hospital cardiopulmonary rehabilitation program on inspiratory muscle strength and its potential association with improved functional capacity after coronary artery bypass grafting surgery. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- In Hospital Cardiopulmonary Rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2004to Jan 2006
- 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 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Previous history of more than one vessel coronary artery disease
- Lifelong abstinence from tobacco
- Formal indication for CABG
Who cannot join
- Patients older than 75 years of age
- Chronic renal failure (dialysis for more than 3 months)
- Unstable angina in the 48 hours prior to CABG
- Moderate or severe valve disease
- Complex cardiac arrhythmia's
- Stroke
Show all 9Show fewer
- Inability to exercise the lower limbs
- Previous pulmonary disease (forced vital capacity [FVC] < 80% of predicted and/or forced expiratory volume in 1 s [FEV1] < 70% of predicted)
- Previous history of asthma.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 900035-903
About this study
Official title: Inspiratory Muscle Strength as a Determinant of Functional Capacity Early After Coronary Artery Bypass Graft Surgery
The purpose of this study is to evaluate the effects of a 6-day postoperative in hospital cardiopulmonary rehabilitation program on inspiratory muscle strength and its potential association with improved functional capacity after coronary artery bypass grafting surgery.
Read the detailed description
Eligible patients were randomized to a cardiopulmonary rehabilitation program (Rehab; n = 10) or to usual care (Control; n = 10). The randomization was done by the Graphpad StatMate computerized program. Those patients assigned to Control were followed by their own physicians, received routine nursing assistance, were visited daily by the one of the investigators (CPM), but were not exposed to any specific respiratory or motor physical intervention. Those randomized to Rehab received the same medical and nursing care, but followed a structured physical therapy program twice a day.
- Conditions
- Coronary Artery Disease
- Being tested
- In Hospital Cardiopulmonary Rehabilitation
- Keywords
- Physical therapy, Inspiratory muscles, Exercise
- Medical subject headings
- Coronary Artery Disease, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In Hospital Cardiopulmonary RehabilitationOther
Also called Cardiac rehabilitation, Phase one cardiac rehabilitation
The program consisted of bronchial hygiene characterized by detachment and removal of secretions and respiratory exercises which were applied in the respiratory muscles in order to strengthen and increase the resistance. Patients were instructed to maintain diaphragmatic breathing, at a rate of 12 to 18 breaths per minute during EPAP mask use, and the expiratory pressure was increased progressively in the following fashion: 3-8 cm H2O during 3-12 minutes. Also, they performed flexion/extension of hip and knee, active free exercises for upper limbs, ambulation exercise and ascent/descend of stairs
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Other: In Hospital Cardiopulmonary Rehabilitation |
| 2 | No intervention | Those patients assigned to Control were followed by their own physicians, received routine nursing assistance, were visited daily by the one of the investigators (CPM), but were not exposed to any specific respiratory or motor physical intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal inspiratory and expiratory pressure were measured (before, 7 and 30 days after surgery).
Measured: From 1 day before surgery up to 30 days after surgery (CABG)
Secondary outcomes (1)
Six-minute walk test (6MWT) was performed 7 days after surgery, and maximal cardiopulmonary exercise testing (CPET) was performed 30 days after CABG.
Measured: From 7 days after surgery up to 30 days after surgery (CABG)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2009 (estimated)
- Study startAug 2004
- Primary completionJan 2006
- Study completionJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Investigators
- Ricardo Stein, MD.ScD., Principal investigator, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00873028
- Sponsor's protocol ID
- P1CRh
- Status last verified
- Mar 2009
- First submitted
- 30 Mar 2009
- Last updated
- 1 Apr 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Haeffener MP, Ferreira GM, Barreto SS, Arena R, Dall'Ago P. Incentive spirometry with expiratory positive airway pressure reduces pulmonary complications, improves pulmonary function and 6-minute walk distance in patients undergoing coronary artery bypass graft surgery. Am Heart J. 2008 Nov;156(5):900.e1-900.e8. doi: 10.1016/j.ahj.2008.08.006. Epub 2008 Oct 5.
PubMed 19061704Hirschhorn AD, Richards D, Mungovan SF, Morris NR, Adams L. Supervised moderate intensity exercise improves distance walked at hospital discharge following coronary artery bypass graft surgery--a randomised controlled trial. Heart Lung Circ. 2008 Apr;17(2):129-38. doi: 10.1016/j.hlc.2007.09.004. Epub 2007 Dec 3.
PubMed 18060837Dall'Ago P, Chiappa GR, Guths H, Stein R, Ribeiro JP. Inspiratory muscle training in patients with heart failure and inspiratory muscle weakness: a randomized trial. J Am Coll Cardiol. 2006 Feb 21;47(4):757-63. doi: 10.1016/j.jacc.2005.09.052. Epub 2006 Jan 26.
PubMed 16487841Borghi-Silva A, Mendes RG, Costa Fde S, Di Lorenzo VA, Oliveira CR, Luzzi S. The influences of positive end expiratory pressure (PEEP) associated with physiotherapy intervention in phase I cardiac rehabilitation. Clinics (Sao Paulo). 2005 Dec;60(6):465-72. doi: 10.1590/s1807-59322005000600007. Epub 2005 Dec 12.
PubMed 16358136Herdy AH, Marcchi PL, Vila A, Tavares C, Collaco J, Niebauer J, Ribeiro JP. Pre- and postoperative cardiopulmonary rehabilitation in hospitalized patients undergoing coronary artery bypass surgery: a randomized controlled trial. Am J Phys Med Rehabil. 2008 Sep;87(9):714-9. doi: 10.1097/PHM.0b013e3181839152.
PubMed 18716482
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inspiratory Muscle Strength as a Determinant of Functional Capacity Early After Coronary Artery Bypass Graft Surgery
- ClinicalTrials.gov ID
- NCT00873028
- Acronym / sponsor ID
- P1CRh
- Conditions
- Coronary Artery Disease
- Keywords
- Physical therapy, Inspiratory muscles, Exercise
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- Aug 2004
- Primary completion
- Jan 2006 (actual)
- Study completion
- Jan 2006 (actual)
- First posted
- 1 Apr 2009 (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 purpose of this study is to evaluate the effects of a 6-day postoperative in hospital cardiopulmonary rehabilitation program on inspiratory muscle strength and its potential association with improved functional capacity after coronary artery bypass grafting surgery.
Detailed description
Eligible patients were randomized to a cardiopulmonary rehabilitation program (Rehab; n = 10) or to usual care (Control; n = 10). The randomization was done by the Graphpad StatMate computerized program. Those patients assigned to Control were followed by their own physicians, received routine nursing assistance, were visited daily by the one of the investigators (CPM), but were not exposed to any specific respiratory or motor physical intervention. Those randomized to Rehab received the same medical and nursing care, but followed a structured physical therapy program twice a day.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: In Hospital Cardiopulmonary Rehabilitation |
| 2 | No intervention | –Those patients assigned to Control were followed by their own physicians, received routine nursing assistance, were visited daily by the one of the investigators (CPM), but were not exposed to any specific respiratory or motor physical intervention. |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Previous history of more than one vessel coronary artery disease
- Lifelong abstinence from tobacco
- Formal indication for CABG
Key exclusion criteria (9 listed)
- Patients older than 75 years of age
- Chronic renal failure (dialysis for more than 3 months)
- Unstable angina in the 48 hours prior to CABG
- Moderate or severe valve disease
- Complex cardiac arrhythmia's
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 |
|---|---|---|
| In Hospital Cardiopulmonary RehabilitationAlso: Cardiac rehabilitation, Phase one cardiac rehabilitationThe program consisted of bronchial hygiene characterized by detachment and removal of secretions and respiratory exercises which were applied in the respiratory muscles in order to strengthen and increase the resistance. Patients were instructed to maintain diaphragmatic breathing, at a rate of 12 to 18 breaths per minute during EPAP mask use, and the expiratory pressure was increased progressively in the following fashion: 3-8 cm H2O during 3-12 minutes. Also, they performed flexion/extension of hip and knee, active free exercises for upper limbs, ambulation exercise and ascent/descend of stairs | Other | 1 |
Primary outcome
Maximal inspiratory and expiratory pressure were measured (before, 7 and 30 days after surgery).
Time frame: From 1 day before surgery up to 30 days after surgery (CABG)
1 secondary outcome
Six-minute walk test (6MWT) was performed 7 days after surgery, and maximal cardiopulmonary exercise testing (CPET) was performed 30 days after CABG.
Time frame: From 7 days after surgery up to 30 days after surgery (CABG)
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 Apr 2009.
- Results publication: PubMed 19061704Haeffener MP, Ferreira GM, Barreto SS, Arena R, Dall'Ago P. Incentive spirometry with expiratory positive airway pressure reduces pulmonary complications, improves pulmonary function and 6-minute walk distance in patients undergoing coronary artery bypass graft surgery. Am Heart J. 2008 Nov;156(5):900.e1-900.e8. doi: 10.1016/j.ahj.2008.08.006. Epub 2008 Oct 5.
- Results publication: PubMed 18060837Hirschhorn AD, Richards D, Mungovan SF, Morris NR, Adams L. Supervised moderate intensity exercise improves distance walked at hospital discharge following coronary artery bypass graft surgery--a randomised controlled trial. Heart Lung Circ. 2008 Apr;17(2):129-38. doi: 10.1016/j.hlc.2007.09.004. Epub 2007 Dec 3.
- Results publication: PubMed 16487841Dall'Ago P, Chiappa GR, Guths H, Stein R, Ribeiro JP. Inspiratory muscle training in patients with heart failure and inspiratory muscle weakness: a randomized trial. J Am Coll Cardiol. 2006 Feb 21;47(4):757-63. doi: 10.1016/j.jacc.2005.09.052. Epub 2006 Jan 26.
- Results publication: PubMed 16358136Borghi-Silva A, Mendes RG, Costa Fde S, Di Lorenzo VA, Oliveira CR, Luzzi S. The influences of positive end expiratory pressure (PEEP) associated with physiotherapy intervention in phase I cardiac rehabilitation. Clinics (Sao Paulo). 2005 Dec;60(6):465-72. doi: 10.1590/s1807-59322005000600007. Epub 2005 Dec 12.
- Results publication: PubMed 18716482Herdy AH, Marcchi PL, Vila A, Tavares C, Collaco J, Niebauer J, Ribeiro JP. Pre- and postoperative cardiopulmonary rehabilitation in hospitalized patients undergoing coronary artery bypass surgery: a randomized controlled trial. Am J Phys Med Rehabil. 2008 Sep;87(9):714-9. doi: 10.1097/PHM.0b013e3181839152.
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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.
Ricardo Stein, MD.ScD. principal investigator
Hospital de Clinicas de Porto Alegre
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 In Hospital Cardiopulmonary Rehabilitation in people with Coronary Artery Disease, 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 3 inclusion and 9 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 Apr 2009. 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.
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?
Maximal inspiratory and expiratory pressure were measured (before, 7 and 30 days after surgery). (time frame: From 1 day before surgery up to 30 days after surgery (CABG)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00873028, which also lists 5 linked publications.
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 Apr 2009.