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

NCT01714791 | Terminated

• 1 other identifier: 09.07/cardio09.01
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

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

  preoperative (baseline) and 52 weeks postoperative

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

  3 weeks postoperative (baseline) and 12 weeks postoperative

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

  3 weeks postoperative (baseline) and 52 weeks postoperative

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

  3 weeks postoperative (baseline) and 12 weeks postoperative

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

  3 weeks postoperative (baseline) and 52 weeks postoperative

Other Outcomes (2)

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

  3 weeks postoperative (baseline) and 12 weeks postoperative

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

  4, 12 and 52 weeks postoperative

Study Arms (2)

Usual care

ACTIVE COMPARATOR

Patients following the outpatient cardiac rehabilitation program.

Other: Usual care

Usual care and Osteopathic treatment

EXPERIMENTAL

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

Other: Usual care; Other: Osteopathic treatment

Interventions

Usual care OTHER

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

Usual care; Usual care and Osteopathic treatment

Osteopathic treatment OTHER

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.

Usual care and Osteopathic treatment

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hartcentrum Hasselt: lead

Study Sites (1)

Cardiac rehabilitation centre at the Jessa Hospital Hasselt

Hasselt, Limburg, 3500, Belgium

Location

Related Publications (17)

• 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.

  PMID: 15804805 BACKGROUND

• 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.

  PMID: 15204235 BACKGROUND

• 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.

  PMID: 16106113 BACKGROUND

• 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.

  PMID: 15204247 BACKGROUND

• 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. doi: 10.1016/s0304-3959(03)00017-4.

  PMID: 12855337 BACKGROUND

• Kalso E, Mennander S, Tasmuth T, Nilsson E. Chronic post-sternotomy pain. Acta Anaesthesiol Scand. 2001 Sep;45(8):935-9. doi: 10.1034/j.1399-6576.2001.450803.x.

  PMID: 11576042 BACKGROUND

• Locke TJ, Griffiths TL, Mould H, Gibson GJ. Rib cage mechanics after median sternotomy. Thorax. 1990 Jun;45(6):465-8. doi: 10.1136/thx.45.6.465.

  PMID: 2392792 BACKGROUND

• Mazzeffi M, Khelemsky Y. Poststernotomy pain: a clinical review. J Cardiothorac Vasc Anesth. 2011 Dec;25(6):1163-78. doi: 10.1053/j.jvca.2011.08.001. Epub 2011 Sep 29. No abstract available.

  PMID: 21955825 BACKGROUND

• 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. doi: 10.1034/j.1399-6576.2001.450804.x.

  PMID: 11576043 BACKGROUND

• 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. doi: 10.1016/j.ejcts.2011.03.039. Epub 2011 May 10.

  PMID: 21561786 BACKGROUND

• 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.

  PMID: 21044253 BACKGROUND

• 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. doi: 10.1053/rmed.2002.1424.

  PMID: 12693792 BACKGROUND

• 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. doi: 10.2165/00007256-200535120-00005.

  PMID: 16336009 BACKGROUND

• Alston RP, Pechon P. Dysaesthesia associated with sternotomy for heart surgery. Br J Anaesth. 2005 Aug;95(2):153-8. doi: 10.1093/bja/aei152. Epub 2005 May 13.

  PMID: 15894562 BACKGROUND

• 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. doi: 10.1183/09031936.05.00034805. No abstract available.

  PMID: 16055882 BACKGROUND

• Roncada G. Osteopathic treatment leads to significantly greater reductions in chronic thoracic pain after CABG surgery: A randomised controlled trial. J Bodyw Mov Ther. 2020 Jul;24(3):202-211. doi: 10.1016/j.jbmt.2020.03.004. Epub 2020 Mar 17.

  PMID: 32825989 DERIVED

• Roncada G. Effects of osteopathic treatment on pulmonary function and chronic thoracic pain after coronary artery bypass graft surgery (OstinCaRe): study protocol for a randomised controlled trial. BMC Complement Altern Med. 2016 Nov 25;16(1):482. doi: 10.1186/s12906-016-1468-3.

  PMID: 27884147 DERIVED

MeSH Terms

Conditions

Respiratory Insufficiency; Pain

Interventions

Manipulation, Osteopathic

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Gert Roncada, DO, MSc

  Heart Centre Hasselt

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 18, 2012
• First Posted: October 26, 2012
• Study Start: January 1, 2010
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: March 5, 2018

Record last verified: 2018-03

Locations

BE (1)