Effects of Osteopathic Treatment on Pulmonary Function After Coronary Artery Bypass Graft Surgery

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Osteopathy on Pulmonary Function in Patients After Coronary Artery Bypass Graft Surgery: a Randomized Controlled Trial

Conditions
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Mechanical Complication of Coronary Artery Bypass Graft, Respiratory Depression, Pain, Quality of Life

Intervention / Treatment
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* Other: Usual care
* Other: Osteopathic treatment


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Usual care<br>Patients following the outpatient cardiac rehabilitation program. | Other: Usual care<br>* 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.<br>* Other names: Outpatient cardiac rehabilitation;|
| Experimental: Usual care and Osteopathic treatment<br>Patients following the outpatient cardiac rehabilitation program and receiving osteopathic treatment. | Other: Usual care<br>* 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.<br>* Other names: Outpatient cardiac rehabilitation;Other: Osteopathic treatment<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in slow vital capacity (SVC) at 12 weeks. | A Slow Vital Capacity (SVC) test will be performed at each time point. | preoperative (baseline) and 12 weeks postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in slow vital capacity (SVC) at 52 weeks. | A SVC test will be performed at each time point. | 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. | 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. | 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. | 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. | 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. | 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. | 3 weeks postoperative (baseline) and 52 weeks postoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary Artery Bypass Graft, Osteopathic Medicine, Vital Capacity, Quality of Life, Cardiac rehabilitation