Effects of Deep Breathing Exercises Two Months After Cardiac Surgery

This study has been completed.
Sponsor:
Collaborators:
The Swedish Research Council
Örebro County Council
Information provided by (Responsible Party):
Elisabeth Westerdahl, Uppsala University
ClinicalTrials.gov Identifier:
NCT01282671
First received: December 6, 2010
Last updated: June 4, 2014
Last verified: June 2014
  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:


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.


Enrollment: 357
Study Start Date: September 2007
Study Completion Date: August 2012
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.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Sweden
Uppsala University
Uppsala, Sweden, 751 85
Örebro University Hospital
Örebro, Sweden, 701 85
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:
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 4, 2014
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Uppsala University:
breathing exercises
cardiac surgery
lung function
postoperative complication
positive expiratory pressure

ClinicalTrials.gov processed this record on October 22, 2014