Mechanical Complication of Coronary Artery Bypass GraftOSTinCARENCT01714791
Effects of Osteopathic Treatment on Pulmonary Function After Coronary Artery Bypass Graft Surgery
A study testing Osteopathic treatment in people with Mechanical Complication of Coronary Artery Bypass Graft and Respiratory Depression, run by Hartcentrum Hasselt at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Mechanical Complication of Coronary Artery Bypass Graft, Respiratory Depression, Pain
- What is being tested?
- Osteopathic treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 2010to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Cardiac rehabilitation centre at the Jessa Hospital Hasselt
Hasselt, Limburg, 3500
About this study
Official title: Effect of Osteopathy on Pulmonary Function in Patients After Coronary Artery Bypass Graft Surgery: a Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Mechanical Complication of Coronary Artery Bypass Graft, Respiratory Depression, Pain, Quality of Life
- Being tested
- Usual care, Osteopathic treatment
- Keywords
- Coronary Artery Bypass Graft, Osteopathic Medicine, Vital Capacity, Quality of Life, Cardiac rehabilitation
- Medical subject headings
- Respiratory Insufficiency, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual careOther
Also called Outpatient cardiac rehabilitation
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.
Osteopathic treatmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Usual care | Active comparator | Patients following the outpatient cardiac rehabilitation program. Receives: Other: Usual care |
| Usual care and Osteopathic treatment | Experimental | Patients following the outpatient cardiac rehabilitation program and receiving osteopathic treatment. Receives: Other: Usual care; Other: Osteopathic treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in slow vital capacity (SVC) at 12 weeks.
A Slow Vital Capacity (SVC) test will be performed at each time point.
Measured: preoperative (baseline) and 12 weeks postoperative
Secondary outcomes (7)
Change from baseline in slow vital capacity (SVC) at 52 weeks.
A SVC test will be performed at each time point.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 weeks postoperative (baseline) and 52 weeks postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2012 (estimated)
- Study startJan 2010
- Primary completionDec 2017
- Study completionDec 2017
Why it 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Mechanical Complication of Coronary Artery Bypass GraftStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hartcentrum Hasselt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roncada Gert, Hartcentrum Hasselt
- Investigators
- Gert Roncada, DO, MSc, Principal investigator, Heart Centre Hasselt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01714791
- Sponsor's protocol ID
- 09.07/cardio09.01
- Acronym
- OSTinCARE
- Status last verified
- Mar 2018
- First submitted
- 18 Oct 2012
- Last updated
- 5 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 15804805Kristjansdottir 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.
PubMed 15204235Ragnarsdottir 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.
PubMed 16106113Ragnarsdottir 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.
PubMed 15204247Bruce 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.
PubMed 12855337Kalso 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.
PubMed 11576042Locke 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.
PubMed 2392792Mazzeffi 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.
PubMed 21955825Meyerson 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.
PubMed 11576043van 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.
PubMed 21561786van 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.
PubMed 21044253Westerdahl 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.
PubMed 12693792Hansen 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.
PubMed 16336009Alston 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.
PubMed 15894562Miller 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.
PubMed 16055882
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Osteopathy on Pulmonary Function in Patients After Coronary Artery Bypass Graft Surgery: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01714791
- Acronym / sponsor ID
- OSTinCARE / 09.07/cardio09.01
- 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
- Study type
- Interventional
- Recruitment status
- TerminatedReason 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.
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Hartcentrum HasseltUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 26 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual care | Active comparator | Other: Usual carePatients following the outpatient cardiac rehabilitation program. |
| Usual care and Osteopathic treatment | Experimental | Other: Usual care, Other: Osteopathic treatmentPatients following the outpatient cardiac rehabilitation program and receiving osteopathic treatment. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Usual careAlso: Outpatient cardiac rehabilitationPatients 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 | Usual care, Usual care and Osteopathic treatment |
| Osteopathic treatmentPatients 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. | Other | Usual care and Osteopathic treatment |
Primary outcome
Change from baseline in slow vital capacity (SVC) at 12 weeks.
Time frame: preoperative (baseline) and 12 weeks postoperative
A Slow Vital Capacity (SVC) test will be performed at each time point.
7 secondary outcomes
Change from baseline in slow vital capacity (SVC) at 52 weeks.
Time frame: preoperative (baseline) and 52 weeks postoperative
Change from baseline in McNew quality of life questionnaire at 12 weeks.
Time frame: 3 weeks postoperative (baseline) and 12 weeks postoperative
Change from baseline in McNew quality of life questionnaire at 52 weeks.
Time frame: 3 weeks postoperative (baseline) and 52 weeks postoperative
Change in pain from baseline on Visual Analogue Scale (VAS) at 12 weeks postoperative.
Time frame: 3 weeks postoperative (baseline) and 12 weeks postoperative
Change in pain from baseline on VAS at 52 weeks postoperative.
Time frame: 3 weeks postoperative (baseline) and 52 weeks postoperative
Change in thoracic stiffness from baseline on VAS at 12 weeks postoperative.
Time frame: 3 weeks postoperative (baseline) and 12 weeks postoperative
Change in thoracic stiffness from baseline on VAS at 52 weeks postoperative.
Time frame: 3 weeks postoperative (baseline) and 52 weeks postoperative
Results and safety
The study was stopped early (reason given: 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.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2018.
- Background: PubMed 15804805Kristjansdottir 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.
- Background: PubMed 15204235Kristjansdottir 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.
- Background: PubMed 16106113Ragnarsdottir 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.
- Background: PubMed 15204247Ragnarsdottir 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.
- Background: PubMed 12855337Bruce 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.
- Background: PubMed 11576042Kalso 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.
- Background: PubMed 2392792Locke 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.
- Background: PubMed 21955825Mazzeffi 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.
- Background: PubMed 11576043Meyerson 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.
- Background: PubMed 21561786van 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.
- Background: PubMed 21044253van 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.
- Background: PubMed 12693792Westerdahl 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gert Roncada, DO, MSc principal investigator
Heart Centre Hasselt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Osteopathic treatment in people with Mechanical Complication of Coronary Artery Bypass Graft and Respiratory Depression, run by Hartcentrum Hasselt at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: 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.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in slow vital capacity (SVC) at 12 weeks. (time frame: preoperative (baseline) and 12 weeks postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01714791, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2018.