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

This study is currently recruiting participants.
Verified September 2013 by Hartcentrum Hasselt
Sponsor:
Information provided by (Responsible Party):
Roncada Gert, Hartcentrum Hasselt
ClinicalTrials.gov Identifier:
NCT01714791
First received: October 18, 2012
Last updated: September 1, 2013
Last verified: September 2013
  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:


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.

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
  • 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.
  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:

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: September 1, 2013
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 April 16, 2014