Osteopathy in Chronic Obstructive Pulmonary Disease (COPD) Rehabilitation Trial

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ercole Zanotti, Fondazione Salvatore Maugeri
ClinicalTrials.gov Identifier:
NCT00637299
First received: March 10, 2008
Last updated: October 16, 2011
Last verified: October 2011

March 10, 2008
October 16, 2011
January 2008
July 2008   (final data collection date for primary outcome measure)
Walking Ability [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
6 minutes walking test (6MWT)
walking ability (6 minutes walking test) [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00637299 on ClinicalTrials.gov Archive Site
Lung Function Test [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
residual volume (RV)
Lung Function Test [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Osteopathy in Chronic Obstructive Pulmonary Disease (COPD) Rehabilitation Trial
Osteopathic Treatment May Improve Exercise Capacity in Patients With Chronic Obstructive Pulmonary Disease

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.

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.

Interventional
Phase 0
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Chronic Obstructive Pulmonary Disease
  • 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
  • Other: sham osteopathic treatment (SOT+PR)
    Only soft manipulation was performed
    Other Name: SOT+PR
  • 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.
    Intervention: Other: Active osteopathic treatment (OMT+PR): Active Comparator
  • Sham Comparator: SOT + PR
    Sham osteopathic treatment (manipulation)
    Intervention: Other: sham osteopathic treatment (SOT+PR)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
November 2008
July 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • patients affected by COPD

Exclusion Criteria:

  • other diseases other than COPD
Both
45 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00637299
01/2008
No
Ercole Zanotti, Fondazione Salvatore Maugeri
Fondazione Salvatore Maugeri
Not Provided
Principal Investigator: Ercole Zanotti, md Fondazione Salvatore Maugeri
Fondazione Salvatore Maugeri
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP