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Effects of Deep Breathing Exercises Two Months After Cardiac Surgery

Primary Purpose

CABG, Valve Surgery

Status
Completed
Phase
Phase 2
Locations
Sweden
Study Type
Interventional
Intervention
Breathing exercises
Sponsored by
Uppsala University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for CABG focused on measuring breathing exercises, cardiac surgery, lung function, postoperative complication, positive expiratory pressure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Uppsala University
  • Örebro University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Breathing exercises

Control group

Arm Description

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.

No breathing exercises.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
December 6, 2010
Last Updated
June 4, 2014
Sponsor
Uppsala University
Collaborators
The Swedish Research Council, Örebro County Council
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1. Study Identification

Unique Protocol Identification Number
NCT01282671
Brief Title
Effects of Deep Breathing Exercises Two Months After Cardiac Surgery
Official Title
Effects of Deep Breathing Exercises Two Months After Cardiac Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Uppsala University
Collaborators
The Swedish Research Council, Örebro County Council

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
CABG, Valve Surgery
Keywords
breathing exercises, cardiac surgery, lung function, postoperative complication, positive expiratory pressure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
357 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Breathing exercises
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
No breathing exercises.
Intervention Type
Other
Intervention Name(s)
Breathing exercises
Other Intervention Name(s)
Intervention group: Performing breathing exercises., Control group: No breathing exercises.
Intervention Description
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.
Primary Outcome Measure Information:
Title
Lung function measured as Forced expiratory volume in 1 second (FEV1)
Description
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.
Time Frame
Two months after surgery
Secondary Outcome Measure Information:
Title
Postoperative quality of recovery
Description
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.
Time Frame
Two months postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elisabeth Westerdahl, PhD, RPT
Organizational Affiliation
Region Örebro County
Official's Role
Principal Investigator
Facility Information:
Facility Name
Uppsala University
City
Uppsala
ZIP/Postal Code
751 85
Country
Sweden
Facility Name
Örebro University Hospital
City
Örebro
ZIP/Postal Code
701 85
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
24280904
Citation
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.
Results Reference
result
PubMed Identifier
24678691
Citation
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.
Results Reference
result

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Effects of Deep Breathing Exercises Two Months After Cardiac Surgery

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