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Respiratory Resistance Training on Sleep Quality in Persons With Spinal Cord Injury

This study has been terminated.
(unable to recruit participants.)
Sponsor:
Information provided by:
Texas State University, San Marcos
ClinicalTrials.gov Identifier:
NCT00629850
First received: February 25, 2008
Last updated: August 17, 2011
Last verified: August 2011
History of Changes
Results First Received: July 19, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Investigator);   Primary Purpose: Treatment
Condition: Spinal Cord Injury
Intervention: Device: Powerlung Performer

  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
No text entered.

Reporting Groups
  Description
Powerlung Trainer Device The device was used twice a day. Each use consisted of two sets of 10 breaths for each set.
Control This arm of the study will not receive the device.

Participant Flow:   Overall Study
    Powerlung Trainer Device     Control  
STARTED     1     0  
COMPLETED     1     0  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Reporting Groups
  Description
Powerlung Trainer Device The device was used twice a day. Each use consisted of two sets of 10 breaths for each set.
Control This arm of the study will not receive the device.
Total Total of all reporting groups

Baseline Measures
    Powerlung Trainer Device     Control     Total  
Number of Participants  
[units: participants]
 		  1     0     1  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     1     0     1  
>=65 years     0     0     0  
Gender  
[units: participants]
 		     
Female     0     0     0  
Male     1     0     1  
Region of Enrollment  
[units: participants]
 		     
United States     1     0     1  



  Outcome Measures
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1.  Primary:   Number of Participants With Improvement in Sleep Quality.   [ Time Frame: 10 weeks ]
  Show Outcome Measure 1

2.  Primary:   Change in Maximum Voluntary Ventilation Using Pulmonary Function Device   [ Time Frame: 10 weeks ]
  Show Outcome Measure 2

3.  Primary:   Change in Negative Inspiratory Force Using a Pressure Manometer   [ Time Frame: 10 weeks ]
  Show Outcome Measure 3


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


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
Unable to recruit subjects for the study  


Results Point of Contact:  
Name/Title: Chris Russian, Associate Professor
Organization: Texas State Respiratory Care Department
phone: 512-245-3794
e-mail: cr23@txstate.edu


No publications provided


Responsible Party: Chris Russian, Texas State University-San Marcos
ClinicalTrials.gov Identifier: NCT00629850     History of Changes
Other Study ID Numbers: TexasState 2008-29541, IRB# 2008-29541
Study First Received: February 25, 2008
Results First Received: July 19, 2011
Last Updated: August 17, 2011
Health Authority: United States: Institutional Review Board