Effects of Deep Breathing Exercises Two Months After Cardiac Surgery - Full Text View

Purpose

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.

Condition	Intervention	Phase
CABG Valve Surgery	Other: Breathing exercises	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Effects of Deep Breathing Exercises Two Months After Cardiac Surgery

Resource links provided by NLM:

MedlinePlus related topics: Exercise and Physical Fitness Heart Surgery

U.S. FDA Resources

Further study details as provided by Uppsala University:

Primary Outcome Measures:

Lung function measured as Forced expiratory volume in 1 second (FEV1) [ Time Frame: Two months after surgery ] [ Designated as safety issue: Yes ]
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.

Secondary Outcome Measures:

Postoperative quality of recovery [ Time Frame: Two months postoperatively ] [ Designated as safety issue: Yes ]
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.

Estimated Enrollment:	360
Study Start Date:	September 2007
Estimated Study Completion Date:	August 2012
Estimated Primary Completion Date:	August 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 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.	Other: 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 Names: Intervention group: Performing breathing exercises. Control group: No breathing exercises.
No Intervention: Control group No breathing exercises.	Other: 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 Names: Intervention group: Performing breathing exercises. Control group: No breathing exercises.

Arms

Assigned Interventions

Experimental: 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.

Other: 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 Names:

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

No Intervention: Control group

No breathing exercises.

Other: 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 Names:

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

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01282671

Contacts

Contact: Elisabeth A Westerdahl, PhD, RPT

+46 19 6025847

elisabeth.westerdahl@orebroll.se

Locations

Sweden
Uppsala University	Recruiting
Uppsala, Sweden, 751 85
Contact: Charlotte Urell, PhD student 018-471 47 79 charlotte.urell@neuro.uu.se
Örebro University Hospital	Recruiting
Örebro, Sweden, 701 85
Contact: Elisabeth Westerdahl, PhD, RPT +46 19 6025847 elisabeth.westerdahl@orebroll.se
Principal Investigator: Elisabeth Westerdahl, PhD, RPT

Sponsors and Collaborators

Uppsala University

The Swedish Research Council

Örebro County Council

Investigators

Principal Investigator:

Elisabeth Westerdahl, PhD, RPT

University Hospital Orebro

More Information

Publications:

Westerdahl E, Lindmark B, Eriksson T, Friberg O, Hedenstierna G, Tenling A. Deep-breathing exercises reduce atelectasis and improve pulmonary function after coronary artery bypass surgery. Chest. 2005 Nov;128(5):3482-8.

Responsible Party:	Elisabeth Westerdahl, PhD, RPT, Uppsala University
ClinicalTrials.gov Identifier:	NCT01282671 History of Changes
Other Study ID Numbers:	Multic-PEP 2007-160
Study First Received:	December 6, 2010
Last Updated:	June 27, 2012
Health Authority:	Sweden: Regional Ethical Review Board

Keywords provided by Uppsala University:

breathing exercises
cardiac surgery
lung function
postoperative complication
positive expiratory pressure

Additional relevant MeSH terms:

Respiratory Aspiration
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms

ClinicalTrials.gov processed this record on June 18, 2013