Mechanical Complication of Coronary Artery Bypass Graft, Respiratory Depression, Pain, Quality of Life
Conditions
Keywords
Coronary Artery Bypass Graft, Osteopathic Medicine, Vital Capacity, Quality of Life, Cardiac rehabilitation
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.
Interventions
OTHERUsual care
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.
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.
Sponsors
Hartcentrum Hasselt
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in slow vital capacity (SVC) at 12 weeks. | preoperative (baseline) and 12 weeks postoperative | A Slow Vital Capacity (SVC) test will be performed at each time point. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in slow vital capacity (SVC) at 52 weeks. | preoperative (baseline) and 52 weeks postoperative | A SVC test will be performed at each time point. |
| Change from baseline in McNew quality of life questionnaire at 12 weeks. | 3 weeks postoperative (baseline) and 12 weeks postoperative | McNew questionnaire will be done at 3 and 12 weeks after surgery. |
| Change from baseline in McNew quality of life questionnaire at 52 weeks. | 3 weeks postoperative (baseline) and 52 weeks postoperative | McNew questionnaire will be done at 3, 12 and 52 weeks after surgery. |
| Change in pain from baseline on Visual Analogue Scale (VAS) at 12 weeks postoperative. | 3 weeks postoperative (baseline) and 12 weeks postoperative | Pain will be evaluated at 3 and 12 weeks after surgery. |
| Change in thoracic stiffness from baseline on VAS at 12 weeks postoperative. | 3 weeks postoperative (baseline) and 12 weeks postoperative | Thoracic stiffness will be evaluated at 3, 12 weeks after surgery. |
| Change in thoracic stiffness from baseline on VAS at 52 weeks postoperative. | 3 weeks postoperative (baseline) and 52 weeks postoperative | Thoracic stiffness will be evaluated at 3, 12 and 52 weeks after surgery. |
| Change in pain from baseline on VAS at 52 weeks postoperative. | 3 weeks postoperative (baseline) and 52 weeks postoperative | Pain will be evaluated at 3, 12 and 52 weeks after surgery. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in maximal aerobic capacity (VO2max) at 12 weeks postoperative | 3 weeks postoperative (baseline) and 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. |
| Changes in thoracic mobility at 4, 12 and 52 weeks postoperative. | 4, 12 and 52 weeks postoperative | Osteopathic clinical examination of the thorax. |
Countries
Belgium
Outcome results
None listed