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

March 1, 2018 updated by: Roncada Gert, Hartcentrum Hasselt

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

112

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • Limburg
      • Hasselt, Limburg, Belgium, 3500
        • Cardiac rehabilitation centre at the Jessa Hospital Hasselt

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.
Time Frame: preoperative (baseline) and 52 weeks postoperative
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.
Time Frame: 3 weeks postoperative (baseline) and 12 weeks postoperative
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.
Time Frame: 3 weeks postoperative (baseline) and 52 weeks postoperative
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.
Time Frame: 3 weeks postoperative (baseline) and 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.
Time Frame: 3 weeks postoperative (baseline) and 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.
Time Frame: 3 weeks postoperative (baseline) and 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.
Time Frame: 3 weeks postoperative (baseline) and 52 weeks postoperative
Thoracic stiffness will be evaluated at 3, 12 and 52 weeks after surgery.
3 weeks postoperative (baseline) and 52 weeks postoperative

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in maximal aerobic capacity (VO2max) at 12 weeks postoperative
Time Frame: 3 weeks postoperative (baseline) and 12 weeks postoperative
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.
3 weeks postoperative (baseline) and 12 weeks postoperative
Changes in thoracic mobility at 4, 12 and 52 weeks postoperative.
Time Frame: 4, 12 and 52 weeks postoperative
Osteopathic clinical examination of the thorax.
4, 12 and 52 weeks postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hartcentrum Hasselt

Investigators

  • Principal Investigator: Gert Roncada, DO, MSc, Heart Centre Hasselt

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

October 18, 2012

First Submitted That Met QC Criteria

October 25, 2012

First Posted (Estimate)

October 26, 2012

Study Record Updates

Last Update Posted (Actual)

March 5, 2018

Last Update Submitted That Met QC Criteria

March 1, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09.07/cardio09.01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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