Effects of Osteopathic Treatment on Pulmonary Function After Coronary Artery Bypass Graft Surgery - Full Text View

Purpose

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.

Condition	Intervention
Mechanical Complication of Coronary Artery Bypass Graft Respiratory Depression Pain Quality of Life	Other: Usual care Other: Osteopathic treatment

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Effect of Osteopathy on Pulmonary Function in Patients After Coronary Artery Bypass Graft Surgery: a Randomized Controlled Trial

Resource links provided by NLM:

MedlinePlus related topics: Coronary Artery Bypass Surgery Depression Rehabilitation

U.S. FDA Resources

Further study details as provided by Hartcentrum Hasselt:

Primary Outcome Measures:

Change from baseline in slow vital capacity (SVC) at 12 weeks. [ Time Frame: preoperative (baseline) and 12 weeks postoperative ] [ Designated as safety issue: No ]
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. [ Time Frame: preoperative (baseline) and 52 weeks postoperative ] [ Designated as safety issue: No ]
A SVC test will be performed at each time point.
Change from baseline in McNew quality of life questionnaire at 12 weeks. [ Time Frame: 3 weeks postoperative (baseline) and 12 weeks postoperative ] [ Designated as safety issue: No ]
Change from baseline in McNew quality of life questionnaire at 52 weeks. [ Time Frame: 3 weeks postoperative (baseline) and 52 weeks postoperative ] [ Designated as safety issue: No ]
Change in pain from baseline on Visual Analogue Scale (VAS) at 12 weeks postoperative. [ Time Frame: 3 weeks postoperative (baseline) and 12 weeks postoperative ] [ Designated as safety issue: No ]
Change in pain from baseline on VAS at 52 weeks postoperative. [ Time Frame: 3 weeks postoperative (baseline) and 52 weeks postoperative ] [ Designated as safety issue: No ]
Change in thoracic stiffness from baseline on VAS at 12 weeks postoperative. [ Time Frame: 3 weeks postoperative (baseline) and 12 weeks postoperative ] [ Designated as safety issue: No ]
Change in thoracic stiffness from baseline on VAS at 52 weeks postoperative. [ Time Frame: 3 weeks postoperative (baseline) and 52 weeks postoperative ] [ Designated as safety issue: No ]

Other Outcome Measures:

Change from baseline in maximal aerobic capacity (VO2max) at 12 weeks postoperative [ Time Frame: 3 weeks postoperative (baseline) and 12 weeks postoperative ] [ Designated as safety issue: No ]
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. [ Time Frame: 4, 12 and 52 weeks postoperative ] [ Designated as safety issue: No ]
Osteopathic clinical examination of the thorax.

Estimated Enrollment:	252
Study Start Date:	January 2010
Estimated Study Completion Date:	December 2017
Estimated Primary Completion Date:	December 2017 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Usual care Patients following the outpatient cardiac rehabilitation program.	Other: Usual 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. Other Name: Outpatient cardiac rehabilitation
Experimental: Usual care and Osteopathic treatment Patients following the outpatient cardiac rehabilitation program and receiving osteopathic treatment.	Other: Usual 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. Other Name: Outpatient cardiac rehabilitation Other: Osteopathic treatment 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.

Arms

Assigned Interventions

Active Comparator: Usual care

Patients following the outpatient cardiac rehabilitation program.

Other: Usual 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.

Other Name: Outpatient cardiac rehabilitation

Experimental: Usual care and Osteopathic treatment

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

Other: Usual 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.

Other Name: Outpatient cardiac rehabilitation

Other: Osteopathic treatment

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.

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

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Planned Coronary Artery Bypass Graft (CABG) surgery at the Jessa Hospital Hasselt

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01714791

Contacts

Contact: Gert Roncada, DO, MSc	003211352282	gert.roncada@telenet.be
Contact: Paul Dendale, MD, PhD	003211307842	paul.dendale@jessazh.be

Locations

Belgium
Cardiac rehabilitation centre at the Jessa Hospital Hasselt	Recruiting
Hasselt, Limburg, Belgium, 3500
Contact: Jan Berger, BSc jan.berger@jessazh.be
Contact: Paul Dendale, MD, PhD paul.dendale@jessazh.be
Principal Investigator: Gert Roncada, DO, MSc

Sponsors and Collaborators

Hartcentrum Hasselt

Investigators

Principal Investigator:

Gert Roncada, DO, MSc

Heart Centre Hasselt

More Information

Publications:

Kristjánsdóttir A, Ragnarsdóttir 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.

Kristjánsdóttir A, Ragnarsdóttir 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.

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

Ragnarsdóttir M, KristjAnsdóttir A, Ingvarsdóttir 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.

Bruce J, Drury N, Poobalan AS, Jeffrey RR, Smith WC, Chambers WA. The prevalence of chronic chest and leg pain following cardiac surgery: a historical cohort study. Pain. 2003 Jul;104(1-2):265-73. Erratum in: Pain. 2004 Dec;112(3):413.

Kalso E, Mennander S, Tasmuth T, Nilsson E. Chronic post-sternotomy pain. Acta Anaesthesiol Scand. 2001 Sep;45(8):935-9.

Locke TJ, Griffiths TL, Mould H, Gibson GJ. Rib cage mechanics after median sternotomy. Thorax. 1990 Jun;45(6):465-8.

Mazzeffi M, Khelemsky Y. Poststernotomy pain: a clinical review. J Cardiothorac Vasc Anesth. 2011 Dec;25(6):1163-78. Epub 2011 Sep 29. Review.

Meyerson J, Thelin S, Gordh T, Karlsten R. The incidence of chronic post-sternotomy pain after cardiac surgery--a prospective study. Acta Anaesthesiol Scand. 2001 Sep;45(8):940-4.

van Gulik L, Janssen LI, Ahlers SJ, Bruins P, Driessen AH, van Boven WJ, van Dongen EP, Knibbe CA. Risk factors for chronic thoracic pain after cardiac surgery via sternotomy. Eur J Cardiothorac Surg. 2011 Dec;40(6):1309-13. Epub 2011 May 10.

van Leersum NJ, van Leersum RL, Verwey HF, Klautz RJ. Pain symptoms accompanying chronic poststernotomy pain: a pilot study. Pain Med. 2010 Nov;11(11):1628-34. doi: 10.1111/j.1526-4637.2010.00975.x.

Westerdahl E, Lindmark B, Bryngelsson I, Tenling A. Pulmonary function 4 months after coronary artery bypass graft surgery. Respir Med. 2003 Apr;97(4):317-22.

Hansen D, Dendale P, Berger J, Meeusen R. Rehabilitation in cardiac patients:what do we know about training modalities? Sports Med. 2005;35(12):1063-84. Review.

Alston RP, Pechon P. Dysaesthesia associated with sternotomy for heart surgery. Br J Anaesth. 2005 Aug;95(2):153-8. Epub 2005 May 13.

Miller MR, Hankinson J, Brusasco V, Burgos F, Casaburi R, Coates A, Crapo R, Enright P, van der Grinten CP, Gustafsson P, Jensen R, Johnson DC, MacIntyre N, McKay R, Navajas D, Pedersen OF, Pellegrino R, Viegi G, Wanger J; ATS/ERS Task Force. Standardisation of spirometry. Eur Respir J. 2005 Aug;26(2):319-38. No abstract available.

Responsible Party:	Roncada Gert, Principal Investigator, Hartcentrum Hasselt
ClinicalTrials.gov Identifier:	NCT01714791 History of Changes
Other Study ID Numbers:	09.07/cardio09.01
Study First Received:	October 18, 2012
Last Updated:	October 25, 2012
Health Authority:	Belgium: Ethics Committee

Keywords provided by Hartcentrum Hasselt:

Coronary Artery Bypass Graft
Osteopathic Medicine
Vital Capacity
Quality of Life
Cardiac rehabilitation

Additional relevant MeSH terms:

Depression
Depressive Disorder
Respiratory Insufficiency
Behavioral Symptoms

Mood Disorders
Mental Disorders
Respiration Disorders
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 19, 2013

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