An interventional study of Usual care and Osteopathic treatment in Mechanical Complication of Coronary Artery Bypass Graft, Respiratory Depression and Pain, sponsored by Hartcentrum Hasselt. Terminated at 1 site in Belgium. Per ClinicalTrials.gov, last updated 2018-03-05.
Sponsored by Hartcentrum Hasselt · Not applicable, Interventional, and Treatment
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.
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.
1,650 studies on the registry are indexed under Respiratory Insufficiency; 297 are open to participants now.
This study's enrollment of 112 is above the median of 55 across 1,042 interventional studies indexed under Respiratory Insufficiency.
Browse Respiratory Insufficiency studies →Hartcentrum Hasselt is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients following the outpatient cardiac rehabilitation program.
Other: Usual care
Patients following the outpatient cardiac rehabilitation program and receiving osteopathic treatment.
Other: Usual care · Other: Osteopathic treatment
Patients exercise at a heart rate corresponding to 65% of baseline Vo2peak. Each exercise training session takes 40-60 minutes. Exercise time is apportioned as follows: 42% on the treadmill, 33% on the circle ergometer and 25% on the arm cranking device. All patients exercise under close supervision 3 days per week for a total duration of 12 weeks.
Also known as: Outpatient cardiac rehabilitation
Patients receive 4 osteopathic treatments (OT). OT is performed in week 4, 5, 8 and 12 postoperative. Depending on what is found in the patient, treatments consist mostly of one or more of the following approaches: * Structural High Velocity Low Amplitude-techniques. * Muscle Energy Techniques. * General osteopathic mobilisations. * Functional techniques (Sutherland-, Jones-techniques,...) including inhibition techniques. * Fascia techniques. * Soft tissue- and connective tissue techniques. * Neurovisceral and neurolymphatic reflex techniques. * Fluidal techniques (lymphatic manipulative techniques,...). * Visceral manipulations. * Neurocranial and viscerocranial techniques.
Change from baseline in slow vital capacity (SVC) at 12 weeks.
A Slow Vital Capacity (SVC) test will be performed at each time point.
Time frame: preoperative (baseline) and 12 weeks postoperative
Change from baseline in slow vital capacity (SVC) at 52 weeks.
A SVC test will be performed at each time point.
Time frame: preoperative (baseline) and 52 weeks postoperative
Change from baseline in McNew quality of life questionnaire at 12 weeks.
McNew questionnaire will be done at 3 and 12 weeks after surgery.
Time frame: 3 weeks postoperative (baseline) and 12 weeks postoperative
Change from baseline in McNew quality of life questionnaire at 52 weeks.
McNew questionnaire will be done at 3, 12 and 52 weeks after surgery.
Time frame: 3 weeks postoperative (baseline) and 52 weeks postoperative
Change in pain from baseline on Visual Analogue Scale (VAS) at 12 weeks postoperative.
Pain will be evaluated at 3 and 12 weeks after surgery.
Time frame: 3 weeks postoperative (baseline) and 12 weeks postoperative
Change in pain from baseline on VAS at 52 weeks postoperative.
Pain will be evaluated at 3, 12 and 52 weeks after surgery.
Time frame: 3 weeks postoperative (baseline) and 52 weeks postoperative
Change in thoracic stiffness from baseline on VAS at 12 weeks postoperative.
Thoracic stiffness will be evaluated at 3, 12 weeks after surgery.
Time frame: 3 weeks postoperative (baseline) and 12 weeks postoperative
Change in thoracic stiffness from baseline on VAS at 52 weeks postoperative.
Thoracic stiffness will be evaluated at 3, 12 and 52 weeks after surgery.
Time frame: 3 weeks postoperative (baseline) and 52 weeks postoperative
Change from baseline in maximal aerobic capacity (VO2max) at 12 weeks postoperative
All patients will perform a maximal cardiopulmonary exercise test on a cycle ergometer. The test will be performed at the cardiac rehabilitation centre by a trained operator and under supervision of a cardiologist.
Time frame: 3 weeks postoperative (baseline) and 12 weeks postoperative
Changes in thoracic mobility at 4, 12 and 52 weeks postoperative.
Osteopathic clinical examination of the thorax.
Time frame: 4, 12 and 52 weeks postoperative
This study is terminated, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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Hartcentrum Hasselt