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Osteopathy in Chronic Obstructive Pulmonary Disease (COPD) Rehabilitation Trial

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00637299
First Posted: March 17, 2008
Last Update Posted: October 24, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Ercole Zanotti, Fondazione Salvatore Maugeri
  Purpose
The purpose of this trial is to verify if an osteopathic treatment added to usual pulmonary rehabilitation trial is able to improve the walking ability of COPD patients and if there is any influence on lung functionality.

Condition Intervention Phase
Chronic Obstructive Pulmonary Disease Other: Active osteopathic treatment (OMT+PR): Active Comparator Other: sham osteopathic treatment (SOT+PR) Early Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Osteopathic Treatment May Improve Exercise Capacity in Patients With Chronic Obstructive Pulmonary Disease

Resource links provided by NLM:


Further study details as provided by Ercole Zanotti, Fondazione Salvatore Maugeri:

Primary Outcome Measures:
  • Walking Ability [ Time Frame: 4 weeks ]
    6 minutes walking test (6MWT)


Secondary Outcome Measures:
  • Lung Function Test [ Time Frame: 4 weeks ]
    residual volume (RV)


Enrollment: 20
Study Start Date: January 2008
Study Completion Date: November 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Active osteopathic treatment (OMT+PR)
The examination was performed by osteopathic practitioners with emphasis on the neuromusculoskeletal system including palpatory diagnosis for somatic dysfunction and viscerosomatic change, in the context of total patient care. The examination was concerned with range of motion of all parts of the body, performed with the patient in multiple positions to provide static and dynamic evaluation.
Other: Active osteopathic treatment (OMT+PR): Active Comparator
The treatment was done once a week for 4 weeks and lasted 30 minutes.The examination was done according to the following scheme: anamnesis; physical examination (evaluation of the posture, palpation, tests for passive and active motion of areas linked to altered respiratory function); cranic-sacral evaluation (by means of a palpation of the cranic-sacral mechanism).
Other Name: OMT+PR
Sham Comparator: SOT + PR
Sham osteopathic treatment (manipulation)
Other: sham osteopathic treatment (SOT+PR)
Only soft manipulation was performed
Other Name: SOT+PR

Detailed Description:
The investigators decided to perform an osteopathic manipulative treatment (OMT) in a population of COPD patients. OMT was defined as the therapeutic application of manually guided forces by an osteopathic practitioner to improve physiologic function and/or support homeostasis that has been altered by somatic dysfunction. Concerning the respiratory system, osteopathy considers a model that describes the interdependent functions among five body components as follows: 1: the inherent motility of the brain and spinal cord; 2: fluctuation of the cerebrospinal fluid; 3: mobility of the intracranial and intraspinal membranes; 4: articular mobility of the cranial bones; 5: the involuntary mobility of the sacrum between the ilia. This model is the so called primary respiratory mechanism.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients affected by COPD

Exclusion Criteria:

  • other diseases other than COPD
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00637299


Locations
Italy
Fondazione Salvatore Maugeri
Montescano, Pavia, Italy, 27040
Sponsors and Collaborators
Fondazione Salvatore Maugeri
Investigators
Principal Investigator: Ercole Zanotti, md Fondazione Salvatore Maugeri
  More Information

Responsible Party: Ercole Zanotti, MD, Fondazione Salvatore Maugeri
ClinicalTrials.gov Identifier: NCT00637299     History of Changes
Other Study ID Numbers: 01/2008
First Submitted: March 10, 2008
First Posted: March 17, 2008
Results First Submitted: January 5, 2009
Results First Posted: April 20, 2009
Last Update Posted: October 24, 2011
Last Verified: October 2011

Keywords provided by Ercole Zanotti, Fondazione Salvatore Maugeri:
COPD

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases