Effects of Deep Breathing Exercises Two Months After Cardiac Surgery

NCT ID: NCT01282671

Last Updated: 2014-06-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 357 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2012-08-31

Brief 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 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.

Conditions

CABG; Valve Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Breathing exercises

Intervention Type: OTHER

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.

Control group

No breathing exercises.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Other Intervention Names

Intervention group: Performing breathing exercises.; Control group: No breathing exercises.

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Swedish Research Council

OTHER_GOV

Sponsor Role: collaborator

Örebro County Council

OTHER_GOV

Sponsor Role: collaborator

Uppsala University

OTHER

Sponsor Role: lead

Responsible Party

Elisabeth Westerdahl

PhD, RPT

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Elisabeth Westerdahl, PhD, RPT

Role: PRINCIPAL_INVESTIGATOR

Region Örebro County

Locations

Uppsala University

Uppsala, , Sweden

Örebro University Hospital

Örebro, Örebro County, Sweden

Countries

Sweden

References

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.

Reference Type: RESULT

PMID: 24280904 (View on PubMed)

Jonsson 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.

Reference Type: RESULT

PMID: 24678691 (View on PubMed)

Other Identifiers

Multic-PEP 2007-160

Identifier Type: -

Identifier Source: org_study_id