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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
Results First Submitted: January 5, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Condition: Chronic Obstructive Pulmonary Disease
Interventions: Other: Active osteopathic treatment (OMT+PR): Active Comparator
Other: sham osteopathic treatment (SOT+PR)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Active Osteopathic Treatment OMT was defined as the therapeutic application of manually guided forces by an osteopathic practitioner.
Sham Osteopathic Treatment (Manipulation) Sham Osteopathic Treatment was performed applying only soft manipulation

Participant Flow:   Overall Study
    Active Osteopathic Treatment   Sham Osteopathic Treatment (Manipulation)
STARTED   10   10 
COMPLETED   10   10 
NOT COMPLETED   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Active Osteopathic Treatment OMT was defined as the therapeutic application of manually guided forces by an osteopathic practitioner.
Sham Osteopathic Treatment (Manipulation) Sham Osteopathic Treatment was performed applying only soft manipulation
Total Total of all reporting groups

Baseline Measures
   Active Osteopathic Treatment   Sham Osteopathic Treatment (Manipulation)   Total 
Overall Participants Analyzed 
[Units: Participants]
 10   10   20 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   8   4   12 
>=65 years   2   6   8 
Age 
[Units: Years]
Mean (Standard Deviation)
 64.2  (5.5)   63.5  (4.7)   63.8  (5.1) 
Gender 
[Units: Participants]
     
Female   2   3   5 
Male   8   7   15 
Region of Enrollment 
[Units: Participants]
     
Italy   10   10   20 


  Outcome Measures
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1.  Primary:   Walking Ability   [ Time Frame: 4 weeks ]

2.  Secondary:   Lung Function Test   [ Time Frame: 4 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Ercole Zanotti
Organization: Fondazione Salvatore Maugeri
phone: 39 385 247 ext 324
e-mail: ercole.zanotti@fsm.it



Responsible Party: Ercole Zanotti, 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