Clinical trial NCT01714791: Effects of Osteopathic Treatment on Pulmonary Function After Coronary Artery Bypass Graft Surgery
Official title: Effect of Osteopathy on Pulmonary Function in Patients After Coronary Artery Bypass Graft Surgery: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Mechanical Complication of Coronary Artery Bypass Graft
Respiratory Depression
Pain
Quality of Life
Keywords: Coronary Artery Bypass Graft
Osteopathic Medicine
Vital Capacity
Quality of Life
Cardiac rehabilitation
Lead sponsor: Hartcentrum Hasselt
Sponsor class: OTHER
First posted: 2012-10-26
Enrollment: 112
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the short and long term effects of osteopathic treatment on pulmonary function, pain and quality of life in patients after coronary artery bypass graft (CABG) surgery. The study is a randomized controlled trial.

Detailed description: Coronary artery bypass graft (CABG) surgery is performed worldwide. Several studies have found that there is a decrease in pulmonary function, loss of thoracic mobility and a high prevalence of chronic poststernotomy pain (CPSP) after CABG. So far there is no effective treatment for these conditions. The OstinCare study aims to investigate whether osteopathic treatment has an added value in the treatment of these patients.

Eligibility criteria: Inclusion Criteria:

* Planned Coronary Artery Bypass Graft (CABG) surgery at the Jessa Hospital Hasselt
* Planned Endoscopic Atraumatic Coronary Artery Bypass (endo ACAB) surgery at the Jessa Hospital
* Planned Minimal Invasive Aortic Valve Replacement (mini AVR) surgery at the Jessa Hospital

Exclusion Criteria:

* Thoracic surgery in the past
* Redo CABG
* Complications after CABG, requiring long-term (more than 6 days) admission to intensive care
* Pathologies of the lungs
* Pathologies of the heart, other than the coronary artery disease
* Surgery in the sub diaphragmatic region: epigastric region, left and right hypochondriac region.

Primary outcomes:
measure: Change from baseline in slow vital capacity (SVC) at 12 weeks.
timeFrame: preoperative (baseline) and 12 weeks postoperative
Secondary outcomes:
measure: Change from baseline in slow vital capacity (SVC) at 52 weeks.
timeFrame: preoperative (baseline) and 52 weeks postoperative
measure: Change from baseline in McNew quality of life questionnaire at 12 weeks.
timeFrame: 3 weeks postoperative (baseline) and 12 weeks postoperative
measure: Change from baseline in McNew quality of life questionnaire at 52 weeks.
timeFrame: 3 weeks postoperative (baseline) and 52 weeks postoperative
measure: Change in pain from baseline on Visual Analogue Scale (VAS) at 12 weeks postoperative.
timeFrame: 3 weeks postoperative (baseline) and 12 weeks postoperative
measure: Change in pain from baseline on VAS at 52 weeks postoperative.
timeFrame: 3 weeks postoperative (baseline) and 52 weeks postoperative
measure: Change in thoracic stiffness from baseline on VAS at 12 weeks postoperative.
timeFrame: 3 weeks postoperative (baseline) and 12 weeks postoperative
measure: Change in thoracic stiffness from baseline on VAS at 52 weeks postoperative.
timeFrame: 3 weeks postoperative (baseline) and 52 weeks postoperative
Other outcomes:
measure: Change from baseline in maximal aerobic capacity (VO2max) at 12 weeks postoperative
timeFrame: 3 weeks postoperative (baseline) and 12 weeks postoperative
measure: Changes in thoracic mobility at 4, 12 and 52 weeks postoperative.
timeFrame: 4, 12 and 52 weeks postoperative
Locations:
city: Hasselt
country: Belgium
facility: Cardiac rehabilitation centre at the Jessa Hospital Hasselt
state: Limburg
Study officials:
affiliation: Heart Centre Hasselt
name: Gert Roncada, DO, MSc
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Roncada G. Osteopathic treatment leads to significantly greater reductions in chronic thoracic pain after CABG surgery: A randomised controlled trial. J Bodyw Mov Ther. 2020 Jul;24(3):202-211. doi: 10.1016/j.jbmt.2020.03.004. Epub 2020 Mar 17.
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