CABGPhase 2NCT01282671
Effects of Deep Breathing Exercises Two Months After Cardiac Surgery
A Phase 2 study testing Breathing exercises in people with CABG and Valve Surgery, run by Uppsala University at 2 sites in Sweden.
Trial summary
Hypothesis: Deep breathing exercises performed during the first two months after cardiac surgery, will improve pulmonary function and patient-perceived quality of recovery. Specific aim: To evaluate the effectiveness of breathing exercises performed with a mechanical device for positive expiratory pressure during the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CABG, Valve Surgery
- What is being tested?
- Breathing exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 357 participants
- Where
- 2 sitesSweden
- Study dates
- Sep 2007to Aug 2012
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A sample of 360 adults (>18 years) patients undergoing cardiac surgery at the two University hospitals are invited to participate in the study.
- Type of cardiac surgery included will be Coronary artery bypass graft surgery (CABG) with saphenous vein grafts and/or internal mammary artery graft, valve surgery or combinations of CABG and valve surgery.
Who cannot join
- Patients who have an emergency operation, previous cardiac or lung surgery, renal dysfunction requiring dialysis or are unable to communicate in Swedish will not be included.
- Patients who requires more than 24 hours respirator treatment, reintubation, reoperation, sternum instability/infection or develop a neurological, mental or haemodynamic complication that affects the patients' ability to collaborate, will be excluded.
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
Örebro University Hospital
Örebro, Örebro County, 701 85
Uppsala University
Uppsala, 751 85
About this study
Hypothesis: Deep breathing exercises performed during the first two months after cardiac surgery, will improve pulmonary function and patient-perceived quality of recovery.
Specific aim: To evaluate the effectiveness of breathing exercises performed with a mechanical device for positive expiratory pressure during the first two months after cardiac surgery compared to a control group performing no breathing exercises.
Design: A prospective, randomized, controlled two-center study.
Read the detailed description
Contribution: The study will be taken place at two University hospitals in Sweden.
Uppsala university hospital (PhD, Registered physical therapist (RPT)) Margareta Emtner and RPT Charlotte Urell) and Örebro university hospital; (Elisabeth Westerdahl and RPT Marcus Jonsson).
Time planning: Application to the Research Ethics Committee april 2007. Data collection 2007-2011. Statistical analysis and manuscript writing 2011.
- Conditions
- CABG, Valve Surgery
- Being tested
- Breathing exercises
- Keywords
- breathing exercises, cardiac surgery, lung function, postoperative complication, positive expiratory pressure
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breathing exercisesOther
Also called Intervention group: Performing breathing exercises., Control group: No breathing exercises.
On the fourth postoperative day the patients are randomly assigned to a Treatment group continuing to perform deep breathing exercises for 2 months postoperatively and to a Control group who will perform no breathing exercises after the third postoperative day. Patient management is otherwise similar in the groups. The patients in the Deep breathing group will be instructed to perform breathing exercises (3 x 10 deep breaths) 5 times a day (document compliance) during the two postoperative months. A Positive expiratory pressure (PEP) device PEP ventil, System 22 (Rium Medical, Täby, Sweden) is used to create an expiratory resistance of +10 cm H2O.
| Study group | Role | What they receive |
|---|---|---|
| Breathing exercises | Experimental | On the fourth postoperative day the patients are randomly assigned to a Treatment group continuing to perform deep breathing exercises for 2 months postoperatively and to a Control group who will perform no breathing exercises after the third postoperative day. Patient management is otherwise similar in the groups. The patients in the Deep breathing group will be instructed to perform breathing exercises (3 x 10 deep breaths) 5 times a day (document compliance) during the two postoperative months. Receives: Other: Breathing exercises |
| Control group | No intervention | No breathing exercises. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung function measured as Forced expiratory volume in 1 second (FEV1)
Spirometry is performed preoperatively and 2 months after surgery at the Departments of Clinical Physiology. A Jaeger MasterScreen Pulmonary functiontest (PFT)/Bodybox will be used at the University hospitals in Uppsala and Örebro. The medical laboratory technologists are blinded to the patient's treatment allocation. Static and dynamic lung volumes will be measured.
Measured: Two months after surgery
Secondary outcomes (1)
Postoperative quality of recovery
Physical activity, postoperative pain, day of discharge, signs of pneumonia or pulmonary comlications will be noted. Patient-perceived quality of recovery will be assessed using a translated version of a recently validated quality of recovery score (QoR-40) designed to measure the patient's health status after surgery and anaesthesia. The SF (short form) -36 (first version) will be used for assessment of quality of life aspects.
Measured: Two months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2011 (estimated)
- Study startSep 2007
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CABGStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 357 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Collaborators
- The Swedish Research Council, Örebro County Council
- Responsible party
- Principal investigator, Elisabeth Westerdahl, Uppsala University
- Investigators
- Elisabeth Westerdahl, PhD, RPT, Principal investigator, Region Örebro County
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01282671
- Sponsor's protocol ID
- Multic-PEP 2007-160
- Status last verified
- Jun 2014
- First submitted
- 6 Dec 2010
- Last updated
- 5 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Westerdahl E, Urell C, Jonsson M, Bryngelsson IL, Hedenstrom H, Emtner M. Deep breathing exercises performed 2 months following cardiac surgery: a randomized controlled trial. J Cardiopulm Rehabil Prev. 2014 Jan-Feb;34(1):34-42. doi: 10.1097/HCR.0000000000000020.
PubMed 24280904Jonsson M, Urell C, Emtner M, Westerdahl E. Self-reported physical activity and lung function two months after cardiac surgery--a prospective cohort study. J Cardiothorac Surg. 2014 Mar 28;9:59. doi: 10.1186/1749-8090-9-59.
PubMed 24678691
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Deep Breathing Exercises Two Months After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT01282671
- Acronym / sponsor ID
- Multic-PEP 2007-160
- Conditions
- CABG, Valve Surgery
- Keywords
- breathing exercises, cardiac surgery, lung function, postoperative complication, positive expiratory pressure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 357 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Collaborators
- The Swedish Research Council, Örebro County Council
- Study start
- Sep 2007
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 25 Jan 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.
Hypothesis: Deep breathing exercises performed during the first two months after cardiac surgery, will improve pulmonary function and patient-perceived quality of recovery.
Specific aim: To evaluate the effectiveness of breathing exercises performed with a mechanical device for positive expiratory pressure during the first two months after cardiac surgery compared to a control group performing no breathing exercises.
Design: A prospective, randomized, controlled two-center study.
Detailed description
Contribution: The study will be taken place at two University hospitals in Sweden.
Uppsala university hospital (PhD, Registered physical therapist (RPT)) Margareta Emtner and RPT Charlotte Urell) and Örebro university hospital; (Elisabeth Westerdahl and RPT Marcus Jonsson).
Time planning: Application to the Research Ethics Committee april 2007. Data collection 2007-2011. Statistical analysis and manuscript writing 2011.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breathing exercises | Experimental | Other: Breathing exercisesOn the fourth postoperative day the patients are randomly assigned to a Treatment group continuing to perform deep breathing exercises for 2 months postoperatively and to a Control group who will perform no breathing exercises after the third postoperative day. Patient management is otherwise similar in the groups. The patients in the Deep breathing group will be instructed to perform breathing exercises (3 x 10 deep breaths) 5 times a day (document compliance) during the two postoperative months. |
| Control group | No intervention | –No breathing exercises. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- A sample of 360 adults (>18 years) patients undergoing cardiac surgery at the two University hospitals are invited to participate in the study.
- Type of cardiac surgery included will be Coronary artery bypass graft surgery (CABG) with saphenous vein grafts and/or internal mammary artery graft, valve surgery or combinations of CABG and valve surgery.
Key exclusion criteria (2 listed)
- Patients who have an emergency operation, previous cardiac or lung surgery, renal dysfunction requiring dialysis or are unable to communicate in Swedish will not be included.
- Patients who requires more than 24 hours respirator treatment, reintubation, reoperation, sternum instability/infection or develop a neurological, mental or haemodynamic complication that affects the patients' ability to collaborate, will be excluded.
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 |
|---|---|---|
| Breathing exercisesAlso: Intervention group: Performing breathing exercises., Control group: No breathing exercises.On the fourth postoperative day the patients are randomly assigned to a Treatment group continuing to perform deep breathing exercises for 2 months postoperatively and to a Control group who will perform no breathing exercises after the third postoperative day. Patient management is otherwise similar in the groups. The patients in the Deep breathing group will be instructed to perform breathing exercises (3 x 10 deep breaths) 5 times a day (document compliance) during the two postoperative months. A Positive expiratory pressure (PEP) device PEP ventil, System 22 (Rium Medical, Täby, Sweden) is used to create an expiratory resistance of +10 cm H2O. | Other | Breathing exercises |
Primary outcome
Lung function measured as Forced expiratory volume in 1 second (FEV1)
Time frame: Two months after surgery
Spirometry is performed preoperatively and 2 months after surgery at the Departments of Clinical Physiology. A Jaeger MasterScreen Pulmonary functiontest (PFT)/Bodybox will be used at the University hospitals in Uppsala and Örebro. The medical laboratory technologists are blinded to the patient's treatment allocation. Static and dynamic lung volumes will be measured.
1 secondary outcome
Postoperative quality of recovery
Time frame: Two months postoperatively
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 5 Jun 2014.
- Results publication: PubMed 24280904Westerdahl E, Urell C, Jonsson M, Bryngelsson IL, Hedenstrom H, Emtner M. Deep breathing exercises performed 2 months following cardiac surgery: a randomized controlled trial. J Cardiopulm Rehabil Prev. 2014 Jan-Feb;34(1):34-42. doi: 10.1097/HCR.0000000000000020.
- Results publication: PubMed 24678691Jonsson M, Urell C, Emtner M, Westerdahl E. Self-reported physical activity and lung function two months after cardiac surgery--a prospective cohort study. J Cardiothorac Surg. 2014 Mar 28;9:59. doi: 10.1186/1749-8090-9-59.
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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.
Elisabeth Westerdahl, PhD, RPT principal investigator
Region Örebro County
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Breathing exercises in people with CABG and Valve Surgery, run by Uppsala University at 2 sites in Sweden.
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 2 inclusion and 2 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 5 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Lung function measured as Forced expiratory volume in 1 second (FEV1) (time frame: Two months after surgery). 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 NCT01282671, which also lists 2 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 5 Jun 2014.