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
  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)
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 Fondazione Salvatore Maugeri:

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


Secondary Outcome Measures:
  • Lung Function Test [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   45 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients affected by COPD

Exclusion Criteria:

  • other diseases other than COPD
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Ercole Zanotti, MD, Fondazione Salvatore Maugeri
ClinicalTrials.gov Identifier: NCT00637299     History of Changes
Other Study ID Numbers: 01/2008
Study First Received: March 10, 2008
Results First Received: January 5, 2009
Last Updated: October 16, 2011
Health Authority: Italy: Ethics Committee

Keywords provided by Fondazione Salvatore Maugeri:
COPD

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

ClinicalTrials.gov processed this record on July 31, 2014