Clinical trial NCT01282671: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: CABG
Valve Surgery
Keywords: breathing exercises
cardiac surgery
lung function
postoperative complication
positive expiratory pressure
Lead sponsor: Uppsala University
Sponsor class: OTHER
Collaborators: name: The Swedish Research Council
name: Örebro County Council
First posted: 2011-01-25
Enrollment: 357
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Lung function measured as Forced expiratory volume in 1 second (FEV1)
timeFrame: Two months after surgery
Secondary outcomes:
measure: Postoperative quality of recovery
timeFrame: Two months postoperatively
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Uppsala University
city: Örebro
country: Sweden
facility: Örebro University Hospital
Study officials:
affiliation: Region Örebro County
name: Elisabeth Westerdahl, PhD, RPT
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.