Effects of Deep Breathing Exercises Two Months After Cardiac Surgery

NCT01282671 | Completed Phase 2

• 1 other identifier: Multic-PEP 2007-160
• Study Type: interventional
• Target: 357
• Locations: 1 country
• Sites: 2

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.

Conditions

CABG; Valve Surgery

Keywords

breathing exercises; cardiac surgery; lung function; postoperative complication; positive expiratory pressure

Outcome Measures

Primary Outcomes (1)

• 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.

  Two months after surgery

Secondary Outcomes (1)

• Postoperative quality of recovery

  Two months postoperatively

Study Arms (2)

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.

Other: Breathing exercises

Control group

NO INTERVENTION

No breathing exercises.

Interventions

Breathing exercises 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.

Also known as: Intervention group: Performing breathing exercises., Control group: No breathing exercises.

Breathing exercises

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Uppsala University: lead
• The Swedish Research Council: collaborator
• Örebro County Council: collaborator

Study Sites (2)

Uppsala University

Uppsala, 751 85, Sweden

Location

Örebro University Hospital

Örebro, Örebro County, 701 85, Sweden

Location

Related Publications (2)

• 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.

  PMID: 24280904 RESULT

• 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.

  PMID: 24678691 RESULT

MeSH Terms

Conditions

Postoperative Complications

Interventions

Breathing Exercises

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities

Study Officials

• Elisabeth Westerdahl, PhD, RPT

  Region Örebro County

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, RPT

Study Record Dates

• First Submitted: December 6, 2010
• First Posted: January 25, 2011
• Study Start: September 1, 2007
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: June 5, 2014

Record last verified: 2014-06

Locations

SE (2)