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Neuromuscular Electrical Stimulation in Chronic Obstructive Pulmonary Disease (COPD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ercole Zanotti, Fondazione Salvatore Maugeri
ClinicalTrials.gov Identifier:
NCT00677690
First received: May 8, 2008
Last updated: November 4, 2011
Last verified: November 2011
History of Changes
Results First Received: January 5, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Chronic Obstructive Pulmonary Disease
Interventions: Other: neuromuscular electrical stimulation (NMES)
Other: Sham electrical stimulation

  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
2007-2008 - Rehabilitative Pulmonary ward

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
167 COPD patients were admitted.52 out of 167 did not meet the inclusion criteria.19 out of the remaining 115 patients refused to participate.13 out of 96 subjects subsequently dropped out due to acute exacerbation.Our definitive sample was therefore of 83 subjects

Reporting Groups
  Description
Neuromuscular Stimulation and Pulmonary Rehabilitation Patients undergone to combination of neuromuscular stimulation and pulmonary rehabilitation
Pulmonary Rehabilitation Patients undergone to pulmonary rehabilitation

Participant Flow:   Overall Study
    Neuromuscular Stimulation and Pulmonary Rehabilitation     Pulmonary Rehabilitation  
STARTED     42     41  
COMPLETED     42     41  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Reporting Groups
  Description
Neuromuscular Stimulation and Pulmonary Rehabilitation Patients undergone to combination of neuromuscular stimulation and pulmonary rehabilitation
Pulmonary Rehabilitation Patients undergone to pulmonary rehabilitation
Total Total of all reporting groups

Baseline Measures
    Neuromuscular Stimulation and Pulmonary Rehabilitation     Pulmonary Rehabilitation     Total  
Number of Participants  
[units: participants]
 		  42     41     83  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     11     9     20  
>=65 years     31     32     63  
Age  
[units: years]
Mean ± Standard Deviation 		  61.4  ± 7.6     62.8  ± 5.4     62.1  ± 8.4  
Gender  
[units: participants]
 		     
Female     11     12     23  
Male     31     29     60  
Region of Enrollment  
[units: participants]
 		     
Italy     42     41     83  



  Outcome Measures
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1.  Primary:   Exercise Capacity   [ Time Frame: 5 weeks ]
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2.  Primary:   Quadriceps Strength   [ Time Frame: 5 weeks ]
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3.  Secondary:   Dyspnoea   [ Time Frame: 5 weeks ]
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4.  Secondary:   Quality of Life   [ Time Frame: 5 weeks ]
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5.  Secondary:   Respiratory Function   [ Time Frame: 5 weeks ]
  Show Outcome Measure 5


  Serious Adverse Events
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  Other Adverse Events
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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.


Limitations and Caveats
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
No text entered.  


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


No publications provided


Responsible Party: Ercole Zanotti, Fondazione Salvatore Maugeri
ClinicalTrials.gov Identifier: NCT00677690     History of Changes
Other Study ID Numbers: 05/2008
Study First Received: May 8, 2008
Results First Received: January 5, 2009
Last Updated: November 4, 2011
Health Authority: Italy: Ethics Committee