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Osteopathy in Chronic Obstructive Pulmonary Disease (COPD) Rehabilitation Trial

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Early Phase 1
Locations
Italy
Study Type
Interventional
Intervention
Active osteopathic treatment (OMT+PR): Active Comparator
sham osteopathic treatment (SOT+PR)
Sponsored by
Fondazione Salvatore Maugeri
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD

Eligibility Criteria

45 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patients affected by COPD

Exclusion Criteria:

  • other diseases other than COPD

Sites / Locations

  • Fondazione Salvatore Maugeri

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Active osteopathic treatment (OMT+PR)

SOT + PR

Arm Description

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.

Sham osteopathic treatment (manipulation)

Outcomes

Primary Outcome Measures

Walking Ability
6 minutes walking test (6MWT)

Secondary Outcome Measures

Lung Function Test
residual volume (RV)

Full Information

First Posted
March 10, 2008
Last Updated
October 16, 2011
Sponsor
Fondazione Salvatore Maugeri
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1. Study Identification

Unique Protocol Identification Number
NCT00637299
Brief Title
Osteopathy in Chronic Obstructive Pulmonary Disease (COPD) Rehabilitation Trial
Official Title
Osteopathic Treatment May Improve Exercise Capacity in Patients With Chronic Obstructive Pulmonary Disease
Study Type
Interventional

2. Study Status

Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
November 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fondazione Salvatore Maugeri

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
COPD

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active osteopathic treatment (OMT+PR)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
SOT + PR
Arm Type
Sham Comparator
Arm Description
Sham osteopathic treatment (manipulation)
Intervention Type
Other
Intervention Name(s)
Active osteopathic treatment (OMT+PR): Active Comparator
Other Intervention Name(s)
OMT+PR
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
sham osteopathic treatment (SOT+PR)
Other Intervention Name(s)
SOT+PR
Intervention Description
Only soft manipulation was performed
Primary Outcome Measure Information:
Title
Walking Ability
Description
6 minutes walking test (6MWT)
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Lung Function Test
Description
residual volume (RV)
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients affected by COPD Exclusion Criteria: other diseases other than COPD
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ercole Zanotti, md
Organizational Affiliation
Fondazione Salvatore Maugeri
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fondazione Salvatore Maugeri
City
Montescano
State/Province
Pavia
ZIP/Postal Code
27040
Country
Italy

12. IPD Sharing Statement

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Osteopathy in Chronic Obstructive Pulmonary Disease (COPD) Rehabilitation Trial

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