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

Primary Purpose

Mechanical Complication of Coronary Artery Bypass Graft, Respiratory Depression, Pain

Status

Terminated

Phase

Not Applicable

Locations

Belgium

Study Type

Interventional

Intervention

Usual care

Osteopathic treatment

About this trial

This is an interventional treatment trial for Mechanical Complication of Coronary Artery Bypass Graft focused on measuring Coronary Artery Bypass Graft, Osteopathic Medicine, Vital Capacity, Quality of Life, Cardiac rehabilitation

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Cardiac rehabilitation centre at the Jessa Hospital Hasselt

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Usual care

Usual care and Osteopathic treatment

Arm Description

Patients following the outpatient cardiac rehabilitation program.

Patients following the outpatient cardiac rehabilitation program and receiving osteopathic treatment.

Outcomes

Primary Outcome Measures

Change from baseline in slow vital capacity (SVC) at 12 weeks.

A Slow Vital Capacity (SVC) test will be performed at each time point.

Secondary Outcome Measures

Change from baseline in slow vital capacity (SVC) at 52 weeks.

A SVC test will be performed at each time point.

Change from baseline in McNew quality of life questionnaire at 12 weeks.

McNew questionnaire will be done at 3 and 12 weeks after surgery.

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.

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.

Change in pain from baseline on VAS at 52 weeks postoperative.

Pain will be evaluated at 3, 12 and 52 weeks after surgery.

Change in thoracic stiffness from baseline on VAS at 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.

Thoracic stiffness will be evaluated at 3, 12 and 52 weeks after surgery.

Full Information

NCT ID

NCT01714791

First Posted

October 18, 2012

Last Updated

March 1, 2018

Sponsor

Hartcentrum Hasselt

1. Study Identification

Unique Protocol Identification Number

NCT01714791

Brief Title

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

Acronym

OSTinCARE

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2018

Overall Recruitment Status

Terminated

Why Stopped

Lack of new inclusions due to a significant change in surgery technique. An endoscopic a-traumatic coronary artery bypass (endo-ACAB) approach is now used.

Study Start Date

January 2010 (undefined)

Primary Completion Date

December 2017 (Actual)

Study Completion Date

December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hartcentrum Hasselt

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

112 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Usual care

Arm Type

Active Comparator

Arm Description

Patients following the outpatient cardiac rehabilitation program.

Arm Title

Usual care and Osteopathic treatment

Arm Type

Experimental

Arm Description

Patients following the outpatient cardiac rehabilitation program and receiving osteopathic treatment.

Intervention Type

Other

Intervention Name(s)

Usual care

Other Intervention Name(s)

Outpatient cardiac rehabilitation

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Osteopathic treatment

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change from baseline in slow vital capacity (SVC) at 12 weeks.

Description

A Slow Vital Capacity (SVC) test will be performed at each time point.

Time Frame

preoperative (baseline) and 12 weeks postoperative

Secondary Outcome Measure Information:

Title

Change from baseline in slow vital capacity (SVC) at 52 weeks.

Description

A SVC test will be performed at each time point.

Time Frame

preoperative (baseline) and 52 weeks postoperative

Title

Change from baseline in McNew quality of life questionnaire at 12 weeks.

Description

McNew questionnaire will be done at 3 and 12 weeks after surgery.

Time Frame

3 weeks postoperative (baseline) and 12 weeks postoperative

Title

Change from baseline in McNew quality of life questionnaire at 52 weeks.

Description

McNew questionnaire will be done at 3, 12 and 52 weeks after surgery.

Time Frame

3 weeks postoperative (baseline) and 52 weeks postoperative

Title

Change in pain from baseline on Visual Analogue Scale (VAS) at 12 weeks postoperative.

Description

Pain will be evaluated at 3 and 12 weeks after surgery.

Time Frame

3 weeks postoperative (baseline) and 12 weeks postoperative

Title

Change in pain from baseline on VAS at 52 weeks postoperative.

Description

Pain will be evaluated at 3, 12 and 52 weeks after surgery.

Time Frame

3 weeks postoperative (baseline) and 52 weeks postoperative

Title

Change in thoracic stiffness from baseline on VAS at 12 weeks postoperative.

Description

Thoracic stiffness will be evaluated at 3, 12 weeks after surgery.

Time Frame

3 weeks postoperative (baseline) and 12 weeks postoperative

Title

Change in thoracic stiffness from baseline on VAS at 52 weeks postoperative.

Description

Thoracic stiffness will be evaluated at 3, 12 and 52 weeks after surgery.

Time Frame

3 weeks postoperative (baseline) and 52 weeks postoperative

Other Pre-specified Outcome Measures:

Title

Change from baseline in maximal aerobic capacity (VO2max) at 12 weeks postoperative

Description

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

Title

Changes in thoracic mobility at 4, 12 and 52 weeks postoperative.

Description

Osteopathic clinical examination of the thorax.

Time Frame

4, 12 and 52 weeks postoperative

10. Eligibility

Sex

All

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gert Roncada, DO, MSc

Organizational Affiliation

Heart Centre Hasselt

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cardiac rehabilitation centre at the Jessa Hospital Hasselt

City

Hasselt

State/Province

Limburg

ZIP/Postal Code

3500

Country

Belgium

12. IPD Sharing Statement

Citations:

PubMed Identifier

15804805

Citation

Kristjansdottir A, Ragnarsdottir M, Hannesson P, Beck HJ, Torfason B. Chest wall motion and pulmonary function are more diminished following cardiac surgery when the internal mammary artery retractor is used. Scand Cardiovasc J. 2004 Dec;38(6):369-74. doi: 10.1080/14017430410016396.

Results Reference

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PubMed Identifier

15204235

Citation

Kristjansdottir A, Ragnarsdottir M, Hannesson P, Beck HJ, Torfason B. Respiratory movements are altered three months and one year following cardiac surgery. Scand Cardiovasc J. 2004 May;38(2):98-103. doi: 10.1080/14017430410028492.

Results Reference

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PubMed Identifier

16106113

Citation

Ragnarsdottir M, Kristinsdottir EK. Breathing movements and breathing patterns among healthy men and women 20-69 years of age. Reference values. Respiration. 2006;73(1):48-54. doi: 10.1159/000087456. Epub 2005 Aug 11.

Results Reference

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PubMed Identifier

15204247

Citation

Ragnarsdottir M, KristjAnsdottir A, Ingvarsdottir I, Hannesson P, Torfason B, Cahalin L. Short-term changes in pulmonary function and respiratory movements after cardiac surgery via median sternotomy. Scand Cardiovasc J. 2004 Mar;38(1):46-52. doi: 10.1080/14017430310016658.

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Citation

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Citation

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Citation

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Citation

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Results Reference

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

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